FDA Approves Guardant360 CDx as Companion Diagnostic for AstraZeneca's ETCAMAH

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 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 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.