Tools, Diagnostics & CDMO

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.

Andelyn Biosciences announced it is now manufacturing FAYUVI, Ultragenyx Pharmaceutical Inc.'s FDA-approved gene therapy for Sanfilippo syndrome type A, also known as mucopolysaccharidosis type IIIA, for commercial supply at its Columbus, Ohio facility. The move follows the U.S. Food and Drug Administration's approval of FAYUVI, making it the first FDA-approved gene therapy manufactured using the Andelyn AAV Curator Platform process. Sanfilippo syndrome type A is a rare, fatal lysosomal storage disease that primarily affects the central nervous system and is marked by rapid neurodegeneration beginning in early childhood; it is estimated to affect 3,000 to 5,000 patients worldwide, with a median life expectancy of 15 years. Andelyn Chief Executive Officer Wade Macedone said the company is proud to manufacture an FDA-approved gene therapy for commercial use using an AAV Curator Platform process, calling the milestone a reflection of the purpose behind Andelyn's founding. Andelyn, a full-service FDA-inspected cell and gene therapy commercial CDMO with more than 20 years of experience, has produced clinical and commercial material for more than 500 cGMP batches and 85 global clinical trials.

Charles River Laboratories International unveiled new rapid cell banking and release programs that use advanced sequencing and in vitro tools to shorten biologics and advanced therapy cell bank lead times for biopharma clients. The platform cuts cell bank production time by 40% and combines rapid microbiological methods with NGS characterization, including the iDTECT NGS platform, to support regulatory readiness. Charles River says the approach reduces reliance on animal testing by incorporating alternative in vitro methods aligned with the 3Rs framework. The company, a US life sciences group with a market cap of about $13.1b, positions the offering for time-sensitive programs where delays are costly. Investors will watch for booked projects using the iDTECT NGS platform, client mix in advanced therapies, and whether the services appear in updated segment revenue breakdowns.

IP Group PLC reported that its net asset value exceeded GBP1 billion at the end of H1 2026, with NAV per share rising about 3% to 114p and reaching roughly 117p as of 11 September 2026. The company generated GBP69 million in cash proceeds during the half, up from GBP30 million a year earlier, plus GBP17 million after the period, bringing year-to-date proceeds to about GBP86 million and total proceeds since 2025 to GBP154 million, more than halfway toward its GBP250 million target by the end of 2027. Gross cash stood at GBP239 million at period end, while the portfolio was valued at roughly GBP900 million, or about 103p per share, with the top five assets accounting for about 50p per share. The Pfizer royalty interest rose GBP27 million to just over GBP150 million, and Oxford Nanopore posted GBP117 million in revenue, about 12% growth at constant currency, with gross margin up 400 basis points to 62% and its adjusted EBITDA loss more than halved to just over GBP22 million. Profit for the period was GBP31 million, effectively converted into cash, and about GBP50 million of proceeds is available for shareholder returns under the capital allocation policy.

On September 18, the Ministry of Industry and Information Technology, the National Development and Reform Commission, and eight other ministries jointly released the 15th Five-Year Plan for the Development of the Pharmaceutical Industry, proposing that by 2030, biopharmaceutical R&D and application will rank among the world's leaders, and the biopharmaceutical industry will accelerate its rise as a national emerging pillar industry. The plan sets 10 expected indicators covering industrial scale and efficiency, innovative development, enterprise cultivation, and cluster development, including operating revenue of pharmaceutical industrial enterprises above designated size exceeding 3.5 trillion yuan, an average annual growth rate of the innovative drug industry scale exceeding 20 percent, more than 5 products with global annual sales exceeding 1 billion US dollars, first-in-class innovative drugs accounting for more than 25 percent of the global total, more than 200 innovative medical devices launched, 50 pharmaceutical industrial enterprises with annual operating revenue exceeding 10 billion yuan, and 20 pharmaceutical industrial parks at the 100-billion-yuan level. Boosted by this news, the three major stock indices all rose more than 1 percent in early trading that day. Huatian Technology hit the daily limit up, with turnover of 6.065 billion yuan, nearly 1.47 million lots of sealed buy orders on the limit-up board, and nearly 3.3 billion yuan of main capital rushing in, ranking first in the A-share market. Zhou Sicong, fund manager of Ping An Pharmaceutical Select, believes innovative drugs are likely to become an important growth theme, and CITIC Securities said China's innovative drugs have entered a stage of global value realization. According to statistics from Securities Times Data Treasure, since September, Chengdu Leading Pharmaceutical, Asymchem Laboratories, Porton Pharma Solutions, and Hunan Warrant Pharmaceutical have led gains, all rising more than 10 percent, with Chengdu Leading Pharmaceutical up a cumulative 16.87 percent.

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.

Ultragenyx Pharmaceutical Inc. announced that the U.S. Food and Drug Administration granted standard full approval of FAYUVI, also known as UX111, for pediatric patients with mucopolysaccharidosis type IIIA, or Sanfilippo syndrome Type A, making it the first-ever FDA-approved treatment for the progressive and fatal neurodegenerative disease. FAYUVI is a single-dose intravenous AAV9 gene therapy and marks the second gene therapy approval and sixth FDA approval overall for Ultragenyx, which also received a Priority Review Voucher upon the approval. The approval is supported by data from the pivotal Transpher A trial and long-term follow-up extending to nearly 8 years, in which FAYUVI-treated patients in the modified intention-to-treat population of 17 demonstrated a 23.5 point higher cognitive score over an external natural history cohort of 27 untreated patients, with a p-value of less than 0.0001. Ultragenyx expects commercial product to be available for shipment to Qualified Treatment Centers within 30-60 days, supported by its UltraCare program, and the therapy is manufactured entirely in the U.S. at the company's Gene Therapy Manufacturing Facility in Bedford, Massachusetts, and Andelyn Biosciences in Columbus, Ohio. Sanfilippo syndrome Type A is estimated to affect approximately 3,000 to 5,000 patients in commercially accessible geographies, with a median life expectancy of 15 years.

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.

Twist Bioscience announced on 16 September 2026 an agreement with Lilly TuneLab under which Twist will provide antibody characterization data services using preferred Twist protocols to generate high-quality wet lab data that feed Lilly's AI/ML drug discovery models. The collaboration plugs Twist's DNA and antibody capabilities into Lilly's AI-driven discovery ecosystem, potentially deepening its role in data-rich, AI-enhanced antibody development workflows across the biopharma industry. The deal follows Twist's US$300,000,000 follow-on equity raise in August 2026, a pairing that highlights a company still funding growth externally while positioning itself as a preferred data and DNA supplier to big pharma and AI drug discovery partners. Twist's narrative projects $753.3 million in revenue and $127.9 million in earnings by 2029, yielding a $105.30 fair value, a 26% downside to its current price, while some of the most optimistic analysts already expected revenue of about US$715,300,000 and earnings of roughly US$128,500,000 by 2029. The agreement may reinforce that bullish view on AI-driven demand, though it does not by itself resolve the near-term issue of achieving a credible path toward breakeven or reduce dependence on a concentrated set of large NGS customers.

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 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.

AstraZeneca has pledged to invest $15bn in China, deepening Western pharmaceutical ties with a country that has become a bona fide drug superpower even as Washington moves to sever them. The company's chief executive, Sir Pascal Soriot, announced the investment during Sir Keir Starmer's Beijing visit, building on existing manufacturing and research sites in Beijing, Shanghai, Wuxi, Taizhou and Qingdao; China is now AstraZeneca's second-largest market, accounting for roughly 12pc of global turnover, with around 17,000 employees and four advanced manufacturing sites. GSK has struck a series of partnerships with Chinese labs, including a $1.3bn pact with Hutchmed for the bulk of licensing rights to what it called first-in-class cancer treatments, and an alliance with Hengrui Pharma worth up to $12bn. Industry-wide licensing deals totalled $138bn last year, a nearly tenfold jump since 2021, according to PharmCube. The US Biosecure Act, signed into law in December, bars companies reliant on federal contracts from working with Chinese biotech firms tied to the military, and the proposed Biotech Investment National Security Act would subject licensing deals involving Chinese companies to national security reviews. China had 1,255 drugs at the research stage by 2024, a nearly eight-fold jump in less than a decade, against 1,441 in America and 400 in Europe.

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.

This year, the pace of Chinese innovative drugs going global has accelerated further, with total out-licensing deal value surpassing $120 billion, up 36% year-on-year. Upfront payments exceeded $10 billion. The market is also showing steady growth in average deal size, rising upfront payment amounts and their share of total deal value, and frequent large transactions. Guosen Securities noted that in the first half of 2026, the pharmaceutical industry's fundamentals continued to improve, with innovative drugs and CXO sectors performing particularly well. Revenue in the innovative drug sector grew 44.1% year-on-year, while CXO sector revenue and net profit rose 23.3% and 15.7% respectively. Growth accelerated further in the second quarter, with innovative drug revenue up 51.3% year-on-year. Domestic innovative drugs are entering a phase of volume expansion under medical insurance, while the second wave of innovative drug globalization is reaching a harvest period. Multiple products have met primary endpoints in global Phase III clinical trials and are about to enter global commercialization. As of 09:59 on September 17, 2026, the STAR Market Pharmaceutical ETF Penghua, tracking the SSE STAR Market Biomedical Index, rose 1.12%. Among constituents, Vazyme rose 5.60%, CanSino Biologics rose 4.38%, and HOB Biotech rose 3.61%, with Dizal Pharmaceutical and Hotgen Biotech also advancing.

S&P Dow Jones Indices announced on September 4, 2026, that Bloom Energy and Illumina are joining the S&P 500 benchmark, with the changes taking effect before trading opens on September 21, 2026, replacing Molson Coors, The Trade Desk, and Builders FirstSource. Bloom Energy arrives after product revenue jumped 215% last quarter on hyperscaler demand for onsite fuel-cell capacity, and management raised full-year revenue guidance to $3.9 billion to $4.2 billion. Illumina returns to the index with second-quarter revenue up 9% and raised EPS guidance of $5.30 to $5.40, though management flagged ongoing China and tariff headwinds. The swap barely moves returns for the Vanguard S&P 500 ETF, since new S&P 500 entrants typically begin well under a tenth of a percent of the index, while Vanguard's June 30, 2026 factsheet showed 38% of the fund in its ten largest holdings, including 8% in NVIDIA alone. The composition shift tilts the index toward growth at the margin, with Bloom carrying a beta of 3.81 and a forward P/E of 57x and Illumina at a forward P/E of 34x, while the departing Molson Coors trades at 7x forward earnings with a 4.9% dividend yield and Builders FirstSource at 14x.

Twist Bioscience and Ginkgo Bioworks traded higher on Wednesday after each announced agreements with Lilly TuneLab, a collaborative drug discovery platform established by Eli Lilly. Under its agreement, Twist Bioscience said it will provide antibody characterization data services to TuneLab companies accessing AI and machine learning drug discovery models trained on Lilly-owned research data. CEO Emily Leproust said Twist has the scale and high-throughput capabilities to generate consistent and reliable antibody characterization data these models need to be trained on. Ginkgo Bioworks, through its Ginkgo Datapoints offering, will provide discovery data generation services to TuneLab users. John Androsavich, General Manager at Ginkgo Datapoints, said layering on Ginkgo's ability to quickly generate high-quality, AI-ready datasets at any scale should let TuneLab participants close the loop between digital design and biological reality faster than ever before.

Ginkgo Bioworks announced that its Ginkgo Datapoints offering has entered a new agreement with Lilly TuneLab, the collaborative AI/ML drug discovery platform created by Eli Lilly and Company. Under the deal, Ginkgo Datapoints will provide discovery data generation services, including small molecule developability (ADME) and antibody developability testing, to companies participating in TuneLab. John Androsavich, General Manager at Ginkgo Datapoints, said the combination of Ginkgo's automation and TuneLab's collaboration platform aims to accelerate next-generation therapeutic development across the industry, letting participants close the loop between digital design and biological reality faster than ever before. Ginkgo said its antibody and small molecule developability screening can turn around results in ML-ready formats that plug directly into TuneLab's predictive models, closing the loop between an AI-generated hypothesis and validated lab data in days rather than months. The standardized assay protocols are expected to help AI/ML models learn more efficiently, and new TuneLab members can now submit Datapoints-generated data to access additional platform model benefits. Lilly TuneLab is part of Lilly Catalyze360, alongside Lilly Ventures, Lilly Gateway Labs, and Lilly ExploR&D.

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.

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 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.

The Ministry of Higher Education, Science, Research and Innovation, together with the Stock Exchange of Thailand and network partners, is preparing to establish a private equity trust, or PE Trust, with a target size of approximately 1 billion baht to invest in New Economy businesses. The SET, the Capital Market Development Fund, or CMDF, the National Innovation Agency, or NIA, as well as financial institutions and private-sector players will take part. Initially, CMDF will contribute 300 million baht and the NIA will allocate another 300 million baht through the Higher Education Science Research and Innovation Policy Council. Funds ready for operation are expected to total around 600 million to 1 billion baht, with a goal of starting investment in a first batch of about two to three startups by the end of this year. The project is driven by three main mechanisms: creating synergy through a University Holding Consortium, or UHC Consortium; using a Venture Builder to incubate businesses; and linking with the stock exchange. The UHC Consortium aims by 2032 to produce 100 deep tech spin-off companies from universities and the network, of which five are targeted to have the potential to list on the stock exchange, and at least one company is to be pushed to a valuation of more than 1 billion US dollars. Priority business groups include Health and Wellness, medical devices, pharmaceuticals, biotech services and energy, such as biosensors and genomics that apply AI and databases. Professor Kittipong Urapeepatanapong, chairman of the Stock Exchange of Thailand, said adding companies in the New Economy group will help create long-term growth for the Thai capital market, since the current structure of listed companies still carries considerable weight in traditional businesses.

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.

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.

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.

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, 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.

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.

GE HealthCare Technologies Inc. has submitted its next-generation StarGuide GX digital 4D CZT SPECT/CT system to the FDA for 510(k) clearance, following recent CE Mark approval in Europe. The system, designed to support theranostics and precision care, aims to expand access to molecular imaging technologies. Jean-Luc Procaccini, president and CEO of Molecular Imaging and Computed Tomography at GE HealthCare, emphasized the company's focus on innovation to meet evolving healthcare needs. Following the announcement, GEHC stock fell 3% at yesterday's close, and year to date shares are down 18.6%, compared with the industry's 20.6% decline, while the S&P 500 has risen 11.6%. The regulatory progress could strengthen GE HealthCare's position in the molecular imaging market, which is projected to reach $9.5 billion by 2026 with a CAGR of 4.6% through 2030, according to Grand View Research.

MarketsandMarkets projects the global MRI systems market will grow from USD 6.88 billion in 2026 to USD 9.68 billion by 2031, at a CAGR of 7.0%. Growth is driven by the rising prevalence of neurological and musculoskeletal disorders, an expanding geriatric population, increasing chronic diseases like cancer, and supportive regulatory and reimbursement policies. The closed MRI systems segment held the largest market share in 2025, as did the fixed/stationary design segment. Asia Pacific is experiencing rapid growth, particularly in China, India, and Southeast Asia. Key players include Siemens Healthineers, GE HealthCare, Philips, FUJIFILM, and Canon, with innovations focusing on AI-enabled workflows and helium-free systems.