Every treatment starts with one question: "What is it, exactly?" Diagnostics is the answer to that question — from an ordinary blood test all the way to reading the genetic code of a tumor to pick the right drug. It's just a few percent of the total cost of care, yet it decides almost every medical decision. This chapter shows how testing is shifting from "telling you whether you're sick yet" to "catching the disease before any symptoms" and "choosing the drug that fits you" — and why it's one of the quietest yet most powerful arenas in healthcare.
NAVER D2SF Backs ImpriMed in $10 Million Series A2 Bridge Round
NAVER D2SF, NAVER's in-house corporate venture arm, has invested in Silicon Valley precision medicine company ImpriMed, joining ImpriMed's $10 million Series A2 bridge round. The round was led by LB Investment, with participation from new investors NAVER D2SF, Samsung Securities, and Alois Ventures, plus follow-on investments from existing investors BonAngels and Han River Partners; it follows ImpriMed's $23 million Series A in 2023. ImpriMed combines ex vivo analysis of patient-derived live cancer cells with genomic, immunophenotypic, and clinical data through its xCellSense platform, and is developing AI models trained on more than 3.5 million data points. The company is preparing to commercialize products for blood cancers and blood infection, targeting FDA clearance and CLIA certification by Q1 2027 for an initial U.S. launch, while in South Korea its multiple myeloma prognosis and therapy-response software has been designated an Innovative Medical Device by the Ministry of Food and Drug Safety. ImpriMed was co-founded by CEO Sungwon Lim and CTO Jamin Koo, and its human healthcare expansion is supported by veterinary precision oncology work covering more than 27,000 tests for canine and feline lymphoma, used by over 600 veterinary hospitals across the United States, Canada, the United Kingdom, France, and South Korea.
Onco360 Named National Pharmacy Partner for AstraZeneca's Etcamah
Onco360 has been selected by AstraZeneca as a national pharmacy partner for Etcamah, also known as camizestrant, the company announced. The therapy is indicated for adult patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of an ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test. Etcamah is an estrogen receptor antagonist that binds to the ligand-binding domain of ERα, antagonizing both wild-type and mutated ESR1 and inducing proteasome-dependent degradation of ERα without agonizing it. Its approval was based on the phase 3 SERENA-6 study, in which Etcamah plus a CDK4/6 inhibitor reduced the risk of disease progression or death by 56% versus an aromatase inhibitor plus a CDK4/6 inhibitor, with median PFS of 16 months versus 9.2 months and a hazard ratio of 0.44. The most common adverse reactions, occurring in at least 20% of patients, included decreased neutrophils, leukocytes, hemoglobin, lymphocytes and platelets, along with visual disturbances and fatigue.
Tempus AI Jumps 30% After Morgan Stanley Lifts Revenue Outlook
Tempus AI shares surged nearly 30% this week after Morgan Stanley spotlighted reimbursement pricing that could add between $330 million and $400 million in combined annual revenue across its xT and xF diagnostics. CEO Eric Lefkofsky estimated xT pricing adds $80 million to $100 million next year, while xF approval and pricing could add $250 million to $300 million annually, and said Tempus should exceed its stated 25% multiyear growth target. The company reported Q2 FY2026 revenue of $382.49 million, up 21.6% year over year, raised full-year guidance to $1.595 billion to $1.605 billion, and reaffirmed adjusted EBITDA of about $65 million. Data licensing bookings totaled roughly $200 million in the quarter, with named customers including AstraZeneca, GlaxoSmithKline, Bristol-Myers Squibb, Merck, Daiichi Sankyo, Levelset Bio, and Insight Pharmaceuticals. Despite a 54.24% one-month gain, the stock remains below its 52-week high of $104.32, and the consensus analyst target price of $68.18 now trails the market price.
SUSMED's Blockchain Clinical Trial System Powers World's First Drug Approval
SUSMED, a Japanese company that develops therapeutic apps and clinical trial support systems, announced on September 16 that a drug tested in a clinical trial using its blockchain-based system has received domestic manufacturing and marketing approval. According to the company's research, this is the world's first drug approval based on the results of a corporate-sponsored clinical trial that used blockchain. The approved drug is Uekix Tablets, indicated for excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea syndrome, among other conditions. Viatris Pharmaceuticals obtained the approval, and SUSMED provided the system for the domestic clinical trial. SUSMED's SourceDataSync uses blockchain technology for data verification, checking whether records of patients' conditions and drug effects match the original records at medical institutions, with the aim of reducing manual confirmation work and data entry at medical institutions while maintaining the reliability of the records. Leading up to this approval, SUSMED conducted verification under the government's regulatory sandbox program, and in December 2020 received a response from the Ministry of Health, Labour and Welfare that blockchain-based data verification could replace conventional work. This was followed by a trial that began in November 2022, and in January 2023 the system was adopted for a trial in a different target disease. The key point this time is that a technology still in the verification stage was used in a clinical trial that led to drug approval, and SUSMED says that a separate comparative study showed a reduction in man-hours for clinical trial confirmation work and other tasks.
Biovica's DiviTum TKa Wins Strongest Evidence Yet in Metastatic Breast Cancer Meta-Analysis
Biovica International announced the publication of a new systematic review and meta-analysis in the peer-reviewed journal The Breast that the company says provides the strongest evidence to date supporting circulating thymidine kinase activity, or TKa, as a prognostic biomarker in hormone receptor-positive metastatic breast cancer. The review included 18 studies with data from nearly 3,000 women, of which 15 studies were included in the meta-analysis, and all eligible studies used Biovica's DiviTum TKa assay to measure TKa in blood. Results showed that patients with high TKa before starting treatment had approximately twice the risk of disease progression and more than twice the risk of death compared with patients with low TKa. High TKa measured at two and four weeks after treatment started was also associated with a substantially higher risk of disease progression, supporting the potential of TKa to provide early information on how a patient's disease is developing during treatment. CEO Theis Kipling said the publication strengthens confidence in the biomarker both for clinical use and as a tool in oncology drug development, and the authors concluded the meta-analysis offers the strongest evidence to date for the clinical validity of circulating TKa as a prognostic biomarker in HR+ metastatic breast cancer.
Sectra Goes Live With Digital Pathology at Four French Hospitals
Sectra has successfully implemented the digital pathology module of its enterprise imaging solution at four hospitals in France's Provence-Alpes-Côte d'Azur region, the first of eight regional hospitals moving onto one shared solution. The first phase covers Institut Paoli-Calmettes in Marseille, Assistance Publique des Hôpitaux de Marseille, Centre Hospitalier Aix-Pertuis, and Centre Antoine Lacassagne in Nice, all of which are now live. The implementations follow orders received under Sectra's 2022 framework agreement with UniHA, a cooperative of French public hospitals that lets connected hospitals purchase the solution on pre-negotiated terms. The second phase, covering the four remaining PACA hospitals — CHU de Nice, Centres Hospitaliers de Toulon and Avignon, and the Centre Hospitalier d'Ajaccio in Corsica — is already underway and planned to be completed during 2027. The digital workflow gives pathologists instant and, if needed, remote access to digital images of tissue samples instead of physical glass slides reviewed in microscopes, easing collaboration within departments, between sites, and for external expert consultations.
GE HealthCare Reportedly in Talks for $1 Billion Sofie Biosciences Deal
GE HealthCare Technologies Inc. is reportedly discussing a possible $1 billion acquisition of Sofie Biosciences, according to Reuters, which reported the talks on September 13 citing the Financial Times and people familiar with the matter. Reuters said it could not independently verify the report and no agreement was confirmed. The two companies already have an existing relationship: under an October 2023 agreement, GE HealthCare licensed global rights to Gallium-68 FAPI-46 and rights outside the United States to Fluorine-18 FAPI-74, while Sofie retained U.S. clinical-development and commercialization rights to F-18 FAPI-74. Those investigational radiotracers target fibroblast activation protein for positron emission tomography scans, and Sofie said in January that seven radiopharmacies were producing F-18 FAPI-74. Sofie also announced in February the first patient dosed in its Phase 3 pancreatic-cancer imaging study, alongside a gastroesophageal-cancer study that had dosed its first patient in December 2025. Reuters' report did not disclose Sofie's revenue, operating profit, cash generation, or financing terms, leaving the reported price unassessable against sustainable returns.
Co-Diagnostics and ReadyGo to Evaluate Blood-Based Molecular Testing, Starting with Ebola
Co-Diagnostics, Inc. and ReadyGo Diagnostics Ltd. announced a collaboration to evaluate the potential use of ReadyGo's sample-preparation technology with the Co-Dx PCR platform for blood-based molecular testing at the point of need, with an initial focus on decentralized Ebola virus detection and outbreak response. The companies are evaluating two potentially complementary technologies: the Co-Dx PCR platform, a point-of-need PCR technology, and GoCollect by ReadyGo, a field sample-preparation system that prepares blood samples for molecular testing at the point of need. The collaboration builds on Co-Dx's earlier proof-of-concept work testing an Ebola assay using plasma as a sample type, and establishing blood as a compatible sample type would extend the Co-Dx PCR platform beyond the swab-based testing it supports today into bloodborne pathogens such as HIV and hepatitis B and C. The companies have begun feasibility work and Co-Dx has taken delivery of ReadyGo materials and devices to support that evaluation, though there can be no assurance that the evaluation will be successful or result in a commercially available product. In the ongoing outbreak in the Democratic Republic of the Congo, the World Health Organization has reported 6,757 confirmed cases and 3,267 deaths as of Sept 7, 2026, for a case fatality rate of approximately 48%, with 61 health zones affected across six provinces, and the WHO has described this as the second-largest Ebola outbreak on record. Co-Dx will host a live press conference and webcast on Wednesday, September 16, 2026, at 10:30 a.m. ET to discuss the collaboration.
Nucleic Acid Isolation Market to Reach $10.52 Billion by 2035
The global nucleic acid isolation and purification market is projected to grow from USD 5.41 billion in 2026 to USD 10.52 billion by 2035, a compound annual growth rate of 6.9%, according to a new report from ResearchAndMarkets.com. Growth is being driven by demand for molecular diagnostics, next-generation sequencing, personalized medicine, genomics research and advanced drug discovery, with magnetic bead-based purification, automated extraction platforms and microfluidic systems improving processing speed and throughput. Approximately 370 companies currently offer nucleic acid isolation and purification products worldwide, with nearly 45% based in the Asia-Pacific region, and kits account for approximately 65% of the market. North America holds more than 40% of the global market, while the United States alone is expected to account for approximately 30% and expand at a CAGR of 6.8% through 2035. The report profiles key players including Roche, Promega, Macherey-Nagel, Bio-Rad, Danaher, Merck KGaA, Norgen Biotek, Perkin Elmer, Qiagen and Thermo Fisher Scientific.
Mayo Clinic and Thermo Fisher Launch Precure, LLC for Early Disease Detection
Mayo Clinic and Thermo Fisher Scientific have launched Precure, LLC, a Mayo Clinic-controlled company that will build one of the world's leading biomedical datasets to identify signs of disease before symptoms appear. Mayo Clinic will serve as majority owner and Thermo Fisher joins as minority owner of the venture, which will generate molecular data from one million biospecimens linked with longitudinal clinical information collected over several years. The effort integrates proteomic, genomic and clinical data, with Thermo Fisher contributing its Olink Explore HT proteomics platform and Thermo Scientific Orbitrap Mass Spectrometry, kits and reagents. Precure, LLC complements Precure Research, Mayo Clinic's investigator-led scientific effort, by providing the scale, infrastructure and collaborations needed to generate population-scale molecular data and translate discoveries into new diagnostics, therapeutics and other healthcare solutions. Mayo Clinic said any financial returns from its involvement would be reinvested in its nonprofit mission of patient care, research and education.
Aliko Scientific Launches Probantes in Brazil With Biodetecta Partnership
Aliko Scientific, the Euronext Growth Paris-listed oncology diagnostics group trading as ALIKO, announced the launch of the Probantes project in Brazil, the ongoing incorporation of Probantes Ltda as a wholly owned Brazilian business unit, and a strategic industrial cooperation agreement with Biodetecta – Life Science Ltda. Probantes is based in Anápolis, Goiás, and will serve as the Group's FISH and molecular probes business unit as well as its commercial platform for South America, with the company expected to be fully established by the end of October and consolidated into Aliko Scientific's financial statements from its date of incorporation. Under the agreement, Probantes will finance the development program and retain ownership of the products, product-specific intellectual property, technical documentation and regulatory rights, while Biodetecta holds commercialization rights in Brazil and Probantes and the Aliko Scientific group retain exclusive commercialization and distribution rights outside Brazil. The cooperation is structured through a Brazilian Sociedade em Conta de Participação, with profits generated within the vehicle allocated 51% to Probantes and 49% to Biodetecta and generally expected to be reinvested in working capital, product development, regulatory activities, production and further expansion. Chief Executive Officer Francesco Trisolini said the establishment of Probantes fills a critical technological gap by adding proprietary FISH probes to Aliko Scientific's integrated diagnostic platform, creating recurring consumable revenues and supporting more flexible commercial models including pay-per-use, pay-per-test, pay-per-report and service-based solutions.
Xukang Gene Withdraws IPO Filing After Nearly Three Years and Eleven Tutoring Sessions
Shanghai Xukang Gene Technology Co., Ltd. has withdrawn its IPO tutoring filing, ending its listing process after nearly three years of tutoring and eleven progress reports. Xukang Gene signed a listing tutoring agreement with Huatai United Securities on November 24, 2023, and had completed eleven tutoring sessions as of July 2026. The final two tutoring progress reports since 2026 show the company still has shortcomings in internal controls and compliance awareness among directors, supervisors, and senior management. Industry insiders believe that a genetic testing pharmaceutical company voluntarily exiting its IPO most likely reflects that its business model sustainability and profitability still need to be strengthened. Xukang Gene's listing difficulties are not an isolated case. Companies such as Shihui Gene, Annoroad, and Zhenhe Technology have also repeatedly stumbled on their listing paths. Since 2026, two other in vitro diagnostics-related companies, Tianjin Bioaosais Biotechnology Co., Ltd. and Dajia Medical Laboratory Co., Ltd., have also withdrawn their IPO tutoring filings. At the industry level, China's genetic testing market reached approximately 48.7 billion yuan in 2025, with a compound annual growth rate exceeding 30%, and is expected to surpass 100 billion yuan by 2030. However, BGI Genomics posted a net loss attributable to shareholders of 617 million yuan in 2025, Berry Genomics has been loss-making for three consecutive years, and Rightongene has been loss-making for a second consecutive year, leaving the industry overall in a pattern of rising revenue without rising profits.
Labcorp Holdings presented a long-term growth strategy and financial forecast at its 2026 Investor Day, reaffirming full-year 2026 adjusted earnings per share guidance of $18.10 to $18.55, above the Wall Street estimate of $18.01, and 2026 sales of $14.710 billion to $14.827 billion, edging past the $14.707 billion estimate. That 2026 revenue guidance comprises Diagnostics Laboratories sales of $11.45 billion to $11.53 billion and Biopharma Laboratory Services sales of $3.269 billion to $3.30 billion. Looking to 2029, management targets a compound annual revenue growth rate of 5% to 8% and compound annual adjusted EPS growth of 8.5% to 11.5%, with adjusted operating margin expanding by 75 to 150 basis points by the end of 2029 and compound annual free cash flow growth mirroring adjusted earnings growth. The company set four strategic priorities: leading specialty testing in oncology, neurology, autoimmune diseases and women's health; becoming a preferred partner for health systems and pharmaceutical companies; advancing personalized health solutions; and integrating artificial intelligence and robotics into its operations.
FDA Approves Telix's Pixclara for Glioma Brain Imaging
The Food and Drug Administration approved Telix Pharmaceuticals' Pixclara, a radioactive imaging drug used to help evaluate patients with glioma, the company said Sunday. Pixclara, also known as floretyrosine F 18, is approved for use with positron emission tomography to help distinguish recurrent or worsening glioma from changes caused by treatment, and may be used alongside other diagnostic methods in adults and children at least one month old. Telix said Pixclara is the first FDA-approved FET-PET imaging agent for glioma in the United States, intended to complement tools such as magnetic resonance imaging when physicians monitor brain tumors and plan treatment. Gliomas account for about 80% of malignant brain tumors, with approximately 24,000 new cases diagnosed annually in the United States, according to figures cited by the company. Telix is also studying the drug, identified in development as TLX101-Px, in a Phase 3 trial involving the diagnosis of brain metastases.
BKGI reports 2025 revenue up 11.81%, prepares for Genomics Thailand Phase 2
Bangkok Genomics Innovation Public Company Limited, or BKGI, reported total revenue of 386.73 million baht for 2025, an increase of 40.86 million baht, or 11.81%, from the previous year, driven by revenue from sales of laboratory products, which came in at 111.87 million baht, up 37.96%, while service revenue rose 4.34%, amid competition and changes in reimbursement policy for prenatal chromosomal abnormality screening services. Dr. Saowalak Dansakul, Chief Executive Officer of BKGI, said the company aims to drive its Genomics and Precision Medicine business in line with the policy of pushing Thailand toward becoming an international health hub, or Medical Hub, and with the trend toward preventive medicine. The company is preparing for opportunities in the Genomics Thailand Phase 2 project and is laying out a B2B business model in the Wellness and Longevity market to support clinics and partners with genetic testing products and genetic counseling personnel. For the second half of the year, the company expects support from the gradual recognition of revenue from sales of test reagents following delivery of Sequencing, or NGS, machines, as well as steady revenue from the Oncology services group reimbursed through benefits of the National Health Security Office, or NHSO. Meanwhile, data from the National Statistical Office indicates that in 2024 Thailand had 13.68 million people aged 60 and over, up from 11.63 million in 2020, a structural factor supporting the preventive health market.
Biovica Q1 Net Sales Rise 56% as Pharma Services Nearly Double
Biovica International AB reported first-quarter net sales of SEK4 million, up 56% year over year and 57% in local currency, driven primarily by its pharma services business. Pharma revenue reached SEK2.9 million, up 95% year over year, while pharma test services revenue jumped 187% on new work orders from existing global pharma partners. US IVD test revenue rose just 1% year over year to SEK1.84 million, with volumes up roughly 20%, held back by a shift toward commercial payer coverage. Operating cash flow was minus SEK16 million, a modest improvement from minus SEK17 million a year earlier, and the cash position rose to SEK51.6 million from SEK16.3 million. The company also detailed a SEK29.2 million rights issue of new Class B shares at SEK0.3 per share, a discount of approximately 23% to the theoretical ex-rights price, expected to be fully covered and guaranteed by largest shareholder HDF and family. Cost restructuring actions are expected to yield annualized savings of SEK3.5 million to SEK3.7 million.
Tempus Launches 100,000-Genome Multimodal Dataset Initiative
Tempus AI announced an initiative to build a research platform containing 100,000 whole genomes linked to longitudinal clinical information over the next several years, with a long-term goal of reaching one million genomes. The company said the effort will create the first de-identified multimodal whole-genome sequencing dataset built around disease populations and patient outcomes and specifically optimized for AI-driven research. The new dataset will be integrated into Tempus' existing de-identified multimodal data environment, where researchers can access genomic information alongside clinical histories, imaging, pathology and patient outcomes, and analyze it through Tempus Lens without moving datasets between systems. Development is already underway and the initial dataset is available through Tempus' Early Adopter Program, with additional members onboarded in waves and general availability planned for mid-2027. Founder and CEO Eric Lefkofsky said adding whole genome data linked to longitudinal outcomes gives researchers a richer foundation to build AI models and ultimately improve patient care.
Beijing Strong Biotechnologies Receives Medical Device Registration Certificate for Type I Collagen Amino-Terminal Extension Peptide Assay Kit
Beijing Strong Biotechnologies, Inc. announced on September 11 that it has recently received a Medical Device Registration Certificate issued by the Beijing Municipal Medical Products Administration. The product is named Type I Collagen Amino-Terminal Extension Peptide Assay Kit, Magnetic Particle Chemiluminescence Immunoassay Method. The registration certificate number is Jing Xie Zhu Zhun 20262400350, the registration category is Class II, and it is valid from the approval date until September 8, 2031. The kit is used for the in vitro quantitative determination of total type I collagen amino-terminal extension peptide, Total-P1NP, in human serum or plasma. The company stated that obtaining this registration certificate enriches its product line in the chemiluminescence segment of in vitro diagnostics, helps enhance its core competitiveness and market expansion capabilities, and will have a positive impact on future operations. The company also cautioned that actual sales will depend on market promotion results, and the specific impact on performance cannot yet be predicted.
Ascelia Pharma Completes FDA Type A Meeting on Orviglance NDA
Ascelia Pharma has completed its previously scheduled Type A meeting with the U.S. Food and Drug Administration regarding the Complete Response Letter for the Orviglance New Drug Application. The meeting, held on September 9, 2026, gave the company an opportunity to discuss the issues the FDA raised in the CRL and to gain further clarity on obtaining regulatory approval for Orviglance in the United States. Ascelia Pharma said it will provide an update on the regulatory path forward after it receives the FDA's official meeting minutes, which are expected within approximately 30 days. The company, headquartered in Malmö, Sweden, and listed on Nasdaq Stockholm under the ticker ACE, is a biotech focused on orphan oncology treatments with two drug candidates, Orviglance and Oncoral, in development.
MedicalSystem Biotechnology obtains Zhejiang medical device registration certificates for two in vitro diagnostic reagent kits
MedicalSystem Biotechnology Co., Ltd., stock code 300439 on the Shenzhen Stock Exchange, announced on September 10 that it recently obtained two Medical Device Registration Certificates for in vitro diagnostic reagents issued by the Zhejiang Medical Products Administration. The Immunoglobulin G4 Assay Kit, using latex immunoturbidimetry, has registration certificate number Zhejiang Medical Device Registration Approval 20262400468, valid from September 7, 2026 to September 6, 2031, and is used for the quantitative in vitro determination of immunoglobulin G4 concentration in human serum. The Ammonia Assay Kit, using the glutamate dehydrogenase method, has registration certificate number Zhejiang Medical Device Registration Approval 20262400475, valid from September 9, 2026 to September 8, 2031, and is used for the quantitative in vitro determination of ammonia concentration in human plasma. The company stated that obtaining these registration certificates enriches its product line in the in vitro diagnostic biochemistry segment, helps enhance its core competitiveness and market expansion capabilities, and will have a positive impact on future operations. The company also cautioned that actual sales will depend on market promotion results, and the specific impact on performance cannot yet be predicted.
FDA Clears Roche and Lilly's Alzheimer's Blood Test
The FDA has cleared Elecsys pTau217, a blood test developed by Roche Holding AG and Eli Lilly and Company, to help identify whether people aged 55 and older with cognitive decline are likely or unlikely to have brain changes associated with Alzheimer's disease. The test will be available through Roche's installed base of more than 4,500 laboratory analyzers in the United States, and Labcorp and Quest Diagnostics also plan to offer it through their networks. This clearance follows European approval in May, marking regulatory progress in two major markets. However, the test is not intended as a standalone diagnostic and must be interpreted with other clinical information, and its price has not been disclosed. The test's potential lies in making Alzheimer's assessment more accessible compared to traditional methods like PET scans or cerebrospinal fluid testing, which are expensive and invasive.
FDA Approves Guardant360 CDx as Companion Diagnostic for AstraZeneca's ETCAMAH
Guardant Health announced that the U.S. Food and Drug Administration has approved its Guardant360 CDx as a companion diagnostic to identify patients with HR-positive, HER2-negative advanced breast cancer with ESR1 mutations who may benefit from AstraZeneca's ETCAMAH (camizestrant). This is the first FDA-approved liquid biopsy companion diagnostic for longitudinal testing in breast cancer, enabling repeat testing every three months to detect emerging ESR1 mutations before clinical or radiographic progression. The approval is based on the Phase III SERENA-6 trial, where ctDNA-guided treatment with camizestrant plus a CDK4/6 inhibitor reduced the risk of disease progression or death by 56% compared to continuing an aromatase inhibitor with a CDK4/6 inhibitor. Patients in the new paradigm experienced a 74% longer median progression-free survival (16.0 vs. 9.2 months) and a 47% reduction in risk of deterioration in global health status. Approximately 37,000 U.S. women with advanced HR-positive breast cancer on aromatase inhibitors could benefit. This marks the 29th companion diagnostic indication for Guardant360 CDx, which is covered by Medicare and commercial payers representing over 300 million covered lives.
Alteogen Signs Option and License Deal with Novartis for Subcutaneous Products
Alteogen Inc. has entered into an option and license agreement with Novartis for the development and commercialization of subcutaneous products using its ALT-B4 enzyme, powered by the Hybrozyme platform. Under the deal, Novartis obtains multiple options to secure exclusive rights to develop and commercialize subcutaneous formulations for several of its products, leveraging ALT-B4 to convert intravenous biologics into more convenient subcutaneous injections. If all options are exercised and milestones met, Alteogen could receive up to US$3,223 million, including option fees, milestone payments, and royalties. This marks Alteogen's fourth licensing agreement this year, underscoring the growing value of its Hybrozyme technology. Alteogen's CEO, Tae-Yon Chun, highlighted the agreement as evidence of the platform's technological strength and commercial potential.
Telix Completes Phase 3 BiPASS Enrollment, Aligns with FDA on NDA Pathway
Telix Pharmaceuticals Limited announced completion of patient enrollment in the Phase 3 BiPASS study of its PSMA-PET imaging agents Illuccix and Gozellix for prostate cancer detection in the pre-biopsy setting, and has aligned with the U.S. Food and Drug Administration on a New Drug Application pathway that, if approved, would support reimbursement and broaden patient access. The study enrolled 350 patients in the U.S. and Australia, making it the first registrational trial of 68Ga-PSMA-PET imaging before biopsy. BiPASS evaluates whether combining MRI with PSMA-PET/CT can improve diagnostic accuracy and reduce unnecessary biopsies, building on prior PRIMARY and PRIMARY2 studies that showed a nearly 50 percent reduction in unnecessary biopsies. Globally, over three million prostate biopsies are performed annually, with up to 75 percent negative, and about one in four patients decline the procedure. Telix's Chief Medical Officer, Dr. David N. Cade, said the rapid recruitment reflects strong enthusiasm for a more accurate, non-invasive diagnostic approach, and successful implementation could establish precision imaging as a critical step in initial diagnosis.
Roche Secures FDA Approval for Alzheimer's Blood Test
Roche Holding has received FDA approval for its Elecsys pTau217 blood test for Alzheimer's disease in the U.S., a diagnostic designed to identify amyloid pathology from a blood sample and widen access to dementia testing across American labs. The FDA also cleared expanded use of Roche's PATHWAY HER2 and VENTANA HER2 Dual ISH tests in metastatic gastroesophageal cancers, broadening options for HER2 testing in cancer care. These approvals highlight how diagnostics and healthcare AI are reshaping clinical workflows, and they fit into Roche's broader strategy of expanding its companion diagnostics portfolio. Investors should watch how quickly U.S. labs adopt the Elecsys pTau217 test across the 4,500 installed cobas instruments, as well as reported testing volumes for the HER2 assays, to gauge the impact on Roche's diagnostics growth.
Natera and Angiex Partner to Evaluate AGX101 Response With Signatera
Natera has announced a collaboration with Angiex to evaluate treatment response to AGX101, an investigational nuclear-delivered antibody-drug conjugate, using its Signatera test in a Phase 1 trial for patients with advanced solid tumors. The partnership aims to use longitudinal circulating tumor DNA monitoring to provide deeper insights into early biologic responses and support the development of AGX101. Following the news, Natera's shares edged up 0.1%, and year to date the stock has gained 47.8%, outperforming the industry's 4.1% growth and the S&P 500's 11.6% rise. The collaboration expands Signatera's use in early-stage clinical programs and strengthens Natera's biopharma relationships, potentially boosting adoption of its molecular residual disease capabilities. Natera's market capitalization stands at $48.79 billion.
Labcorp Unveils First FDA-Cleared Single Biomarker Alzheimer's Blood Test
Labcorp Holdings has introduced the Elecsys pTau-217 blood test, the first FDA-cleared single biomarker test for Alzheimer's disease, which expands access through primary and specialty care with a minimally invasive blood draw. The company also announced a long-term alliance with the National Association of Community Health Centers to support clinical leadership and community health outcomes across the largest US primary care network. These moves highlight how Alzheimer's diagnostics and broader healthcare delivery are changing quickly, and they align with Labcorp's strategy to use its scale and assay portfolio to drive routine test orders. The key proof point will be whether ordering volumes for pTau-217 and related tests build meaningfully within primary care and the NACHC network through 2027 without compressing pricing or margins.
Druckenmiller's Top Holding Is Natera, Not Amazon, Alphabet, or Nvidia
Stanley Druckenmiller's single biggest holding is Natera, a molecular diagnostics company, not Amazon, Alphabet, or Nvidia. Natera focuses on cell-free DNA testing across women's health, oncology, and transplant surveillance, with revenue reaching $752.8 million in Q2 2026, up from $696.6 million in Q1 2026, and full-year guidance raised to $2.85 billion to $2.91 billion. The company's Signatera test for molecular residual disease has secured first FDA-approved companion diagnostic status for blood-based MRD, first PMDA approval in Japan, and first EU IVDR certification for personalized MRD testing in solid tumors. Druckenmiller's position makes Natera nearly one-fifth of his portfolio, signaling conviction in personalized blood-based testing as a core part of future medicine.
BKGI first-half profit surges 400%, advancing Oncology and Genomics
Bangkok Genomics Innovation Public Company Limited, or BKGI, reported net profit of 62.05 million baht in the first half of 2026, up 400% from the same period last year. Total revenue was 309.39 million baht, up 103%. In the second quarter of 2026, net profit was 30.82 million baht, up 618%, and total revenue was 156.25 million baht, up 119%. The company plans to expand its cancer diagnostics business, or Oncology, and sell genetic testing platforms in the second half of the year. It will also launch new projects requiring low investment but with high revenue potential, and targets full-year 2026 revenue growth of 20 to 30%.
Abbott Laboratories and Thermo Fisher Scientific both reported encouraging quarterly results, with Abbott's diagnostics segment sales rising 42% to $3.09 billion in fiscal Q2, surpassing the estimate of $3.02 billion. Abbott reaffirmed its full-year comparable sales growth guidance of 6.5% to 7.5%, while Thermo Fisher's organic revenue increased 5%, signaling a potential recovery in life sciences spending. Thermo Fisher's management highlighted improving customer activity across pharmaceutical and biotechnology markets, and its Analytical Instruments business returned to growth after nearly two years of weak demand. Abbott's diversified portfolio across diagnostics, medical devices, and nutrition provides resilience, while Thermo Fisher's outlook depends more heavily on continued recovery in pharmaceutical and biotechnology spending.
Stanley Druckenmiller's Duquesne Family Office has made Natera its largest stock position at 16.6% of the reported portfolio, worth about $864.9 million, according to a 13F filing dated August 14, 2026. He added 122,700 shares during the second quarter, lifting the stake to about 3.19 million shares even as the stock traded near record highs. Natera reported second-quarter revenue of $752.8 million on August 6, 2026, up 37.7% from a year earlier and beating Wall Street's estimate of about $662.6 million, while oncology test volume jumped 57.2% and full-year revenue guidance was raised to a range of $2.85 billion to $2.91 billion. The company's main product, Signatera, is a blood test that detects tumor DNA after cancer treatment, and Druckenmiller's concentrated bet signals high conviction in cancer diagnostics as a business that grows through any economy. Natera shares closed at $311.69 on August 18, 2026, up about 36% for the year and near a 52-week high of $326.03.
Hematogenix assay underpins FDA accelerated approval of Bristol Myers Squibb's ZENBEXUS
Hematogenix announced that its proprietary Next Generation Flow Cytometry assay for multiple myeloma minimal residual disease served as the analytical method for the pivotal efficacy endpoint supporting the FDA's accelerated approval of Bristol Myers Squibb's ZENBEXUS (iberdomide), the first CELMoD therapy approved for multiple myeloma. The FDA-approved prescribing information states that MRD-negative complete response was assessed using a Hematogenix Next Generation Flow Cytometry assay at a threshold of 10⁻⁵. In the Phase 3 EXCALIBER-RRMM trial, patients treated with ZENBEXUS in combination with daratumumab and hyaluronidase-fihj and dexamethasone achieved an MRD-negative complete response rate of 41%, compared with 21% for patients treated with daratumumab, bortezomib, and dexamethasone, a statistically significant improvement with p<0.0001. Hematogenix President and CEO Dr. Hytham Al-Masri said being named directly in the FDA label for the first approved therapy in a novel drug class validates the precision and scientific rigor of the company's laboratory platform. Hematogenix operates CAP-accredited and CLIA certified laboratories in the United States, United Kingdom, Malaysia, and China.
Kangwei Century's Mycoplasma Pneumoniae Detection Kit Receives Class III Medical Device Registration Certificate
Jiangsu Jianwei Diagnostic Technology Co., Ltd., a wholly-owned subsidiary of Kangwei Century, has independently developed a Mycoplasma pneumoniae nucleic acid and drug-resistance mutation site detection kit using fluorescent PCR. The kit recently obtained a Class III Medical Device Registration Certificate for in vitro diagnostic reagents from the National Medical Products Administration, valid until August 16, 2031. The product is used for in vitro qualitative detection of Mycoplasma pneumoniae DNA and its antibiotic resistance mutation sites 23S rRNA 2063 A to G and 23S rRNA 2064 A to G in human throat swab samples. Using fluorescent PCR technology, it can simultaneously detect the Mycoplasma pneumoniae P1 gene nucleic acid and its macrolide antibiotic resistance mutation sites. A single sampling and a single test can confirm infection and provide drug resistance information at the same time, helping to avoid failure of empirical medication and improve treatment success rates. The product is compatible with mainstream fluorescent quantitative PCR platforms and is suitable for a wide range of settings, including fever clinics, respiratory departments, pediatrics, and primary healthcare institutions. As of the announcement date, this product is the company's fifth Class III registration certificate for respiratory disease detection, further enriching its product pipeline in the field of respiratory pathogen detection. It marks important progress in the company's integrated molecular diagnostic product layout of infection diagnosis plus drug resistance testing, and is expected to enhance the company's competitiveness in the molecular diagnostic market for respiratory infections.
Sansure Biotech's combined dengue and chikungunya nucleic acid test approved for market
Sansure Biotech announced that its dengue virus and chikungunya virus nucleic acid detection kit recently received a medical device registration certificate from the National Medical Products Administration. The product is the first domestically approved combined nucleic acid test for dengue and chikungunya to enter the market.
Guardant Health Surges on FDA Approval and Cancer Screening Momentum
Guardant Health, Inc. contributed to performance in the second quarter of 2026 following a string of positive developments, as several catalysts played out during the quarter. These developments include U.S. Food and Drug Administration approval of an updated version of the Guardant360 liquid biopsy test, American Cancer Society inclusion of the company's Shield test for colorectal cancer screening, and a report of stronger-than-expected first-quarter earnings driven by volume growth and coverage expansion. The one-month return of Guardant Health, Inc. was 9.26%, while its shares traded between $53.40 and $176.58 over the last 52 weeks. On August 14, 2026, Guardant Health, Inc. stock closed at approximately $157.21 per share, with a market capitalization of about $21.68 billion.
Natera Lands New Trial Collaboration for Latitude Test
Natera has announced a new collaboration that places its Latitude molecular residual disease test into a Phase 1 clinical trial for Kupando Therapeutics' lead immunotherapy candidate, KUP-101. The news follows an active stretch for Natera, including recent earnings, raised 2026 revenue guidance, and regulatory milestones in Japan. Natera's share price has returned 60.97% over 90 days and 35.44% year to date, while its three-year total shareholder return stands at 489.22%. The stock last closed at $309.93, above the most-followed fair value estimate of $282.14 but below the Simply Wall St DCF model's fair value of $607.06.
CapsoVision expects FDA clearance for AI Highlights by end of Q3
CapsoVision anticipates FDA clearance for its AI Highlights product by the end of the third quarter, with commercial launch expected shortly thereafter. The company reported second quarter revenue of $3.6 million, up 10% year-over-year, and gross profit of $1.9 million with a 51% gross margin. Operating expenses were $9.5 million, driven by clinical trials, engineering work, and public company costs. CapsoVision also plans to submit its CapsoCam Colon second-generation capsule and AI module for FDA review in the fourth quarter, delayed from the third quarter due to the need for more positive subjects with significant polyps. The company ended the quarter with $9.1 million in cash and established an at-the-market equity offering program of up to $100 million with Cantor Fitzgerald.
Baron Discovery Fund Accumulated CareDx Shares During Reimbursement Uncertainty
Baron Discovery Fund disclosed it meaningfully increased its position in CareDx during the third quarter of 2025 when shares traded between $11 and $12, viewing the price as reflecting a worst-case scenario around a draft Medicare coverage decision. The draft local coverage decision from the CMS MolDX Program proposed limiting reimbursement for CareDx's transplant diagnostic tests, including removing increased coverage for HeartCare and introducing a bundled payment model. CareDx shares have since recovered to the high-$20s as investors recognized the LCD process involves ongoing dialogue, and the company reported first-quarter 2026 revenue up 39% year over year with testing volumes up 17%. CareDx also announced the divestiture of its lab products business and the acquisition of Naveris, marking its entry into head and neck cancer testing.
Labcorp Raises Guidance, Completes Buyback, and Expands Oncology Testing
Labcorp reported higher second-quarter and year-to-date earnings, raised its 2026 revenue growth guidance, completed a large share repurchase program, and made Roche's FDA-approved VENTANA PTEN (SP218) RxDx Assay available nationwide to guide prostate cancer treatment decisions. The company also recently received FDA approval for its PGDx elio tissue complete CDx for advanced melanoma. These moves reinforce Labcorp's role as a major companion diagnostics provider and signal management confidence through upgraded guidance and sustained buybacks. The PTEN assay rollout and upgraded 2026 guidance support a near-term catalyst around mix shift into precision oncology, though risks such as potential PAMA-related reimbursement cuts and pricing pressure in core lab services remain.
Tellgen's Six Alzheimer's Auxiliary Diagnosis Reagent Kits Accepted for Registration by Shanghai Medical Products Administration
Six medical device registration applications submitted by Tellgen and its holding subsidiary Maishibio have been accepted by the Shanghai Medical Products Administration. Among them, the four products submitted by Tellgen are detection kits based on chemiluminescence immunoassay, including kits for measuring beta-amyloid 1-40, beta-amyloid 1-42, phosphorylated Tau181 protein, and phosphorylated Tau217 protein, intended for the auxiliary diagnosis of Alzheimer's disease. The two products submitted by subsidiary Maishibio are measurement kits based on liquid chromatography-tandem mass spectrometry, including a six-class steroid hormone measurement kit and a fat-soluble vitamin measurement kit. The company stated that these products align with its strategic layout and are conducive to expanding its product matrix in non-oncology testing areas, but they are currently in the registration acceptance stage and still need to go through technical review, administrative approval, and other steps. Obtaining the registration certificate is subject to uncertainty and will not affect recent performance.