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Noticias de GH
Eventos de GH
TwinStrand Biosciences Wins, Guardant Health Patent Challenge Rejected
TwinStrand Biosciences "announced that the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) has again rejected Guardant Health, Inc.'s (GH) challenge to a core patent underlying Duplex Sequencing. In an Oct. 14, 2026, Final Written Decision on remand from the U.S. Court of Appeals for the Federal Circuit, the PTAB ruled in favor of the University of Washington (UW), determining that Guardant Health failed to establish the unpatentability of any of the 30 challenged claims of U.S. Patent No. 10,760,127. The '127 patent is owned by UW and exclusively licensed to TwinStrand."
Guardant Health's Guardant360 CDx Receives CE Mark in Europe
Guardant Health (GH) announced that Guardant360 CDx has received CE-marking under Europe's in Vitro Diagnostic Medical Devices Regulation as a companion diagnostic to identify patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer who may benefit from treatment with ETCAMAH, AstraZeneca's (AZN) next-generation oral selective estrogen receptor degrader and complete ER antagonist. Approval in Europe reinforces Guardant Health's commitment to enabling practice-changing ongoing monitoring across the world's largest healthcare markets. With Guardant 360 CDx, clinicians can test for ESR1 mutations in tumors through a simple blood draw, ahead of disease progression. This approach reinforces the transformative role of liquid biopsy in guiding therapy decisions earlier in a breast cancer patient's journey. The European approval follows prior regulatory approvals of Guardant360 CDx as a companion diagnostic for ETCAMAH in the United States and Japan. "Guardant360 CDx offers molecular insights that can support informed treatment decisions for patients with advanced breast cancer, addressing the disease before it gets out of control," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "What is even more exciting is that we see tremendous potential for this type of testing protocol to transform the treatment of other cancer types to change the future of oncology."
Guardant Health Announces COSMOS-MEL01 Study Results
Guardant Health announced Cancer Research Communications, a journal of the American Association for Cancer Research, has published results from the COSMOS-MEL01 study. "The study is the first published prospective, multicenter evaluation of the tissue-free, epigenomic Guardant Reveal blood test for molecular residual disease detection and recurrence monitoring in patients with resected stage II-III melanoma," the company stated. "COSMOS-MEL01 extends the growing body of evidence supporting Guardant Reveal into melanoma and demonstrates the power of epigenomic MRD detection across a diverse set of melanoma subtypes. The ability to identify patients at very high risk shortly after surgery, and to detect molecular recurrence before it appears clinically, could help inform more personalized surveillance and clinical trial strategies. These findings also illustrate the advantages of a tissue-free approach that can deliver molecular insights without the logistical complexity of obtaining and analyzing a tumor specimen," said Helmy Eltoukhy, Guardant Health chairman and co-CEO.
BTIG Analyst Says Grail Cancer Test Received Positive FDA Vote
BTIG analyst Mark Massaro says following the FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee for the Galleri cancer test from Grail (GRAL) that while the company "got a net positive vote," the panelist votes on effectiveness and benefit/risk was "closer than we expected" and "even closer when you listened to the expert's responses to their votes." The firm, which does not have a rating on Grail, thinks the panel "should most likely (but is not a lock to) bode well for the company's FDA approval prospects" and thinks "a rising tide is likely to lift many boats." The first FDA AdCom panel convened to discuss a multi-cancer early detection test will have direct readthroughs to other MCED tests either launched, or in development, from our Guardant Health (GH), Abbott's (ABT) Exact Sciences, Caris Life Sciences (CAI), Freenome (FRNM) and Natera (NTRA), the analyst added.
Guardant Health Receives FDA Approval for Guardant360 CDx as Breast Cancer Companion Diagnostic
Guardant Health (GH) announced that the U.S. Food and Drug Administration has approved Guardant360 CDx as a companion diagnostic to identify patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer harboring tumors with ESR1 mutations before radiographic progression who may benefit from treatment with ETCAMAH, AstraZeneca's (AZN) next-generation oral selective estrogen receptor degrader. Guardant360 CDx is the first FDA-approved liquid biopsy CDx for longitudinal testing in breast cancer, and this approval represents a major shift from therapy selection and switching post-radiographic progression to adaptive cancer management and early interception using pre-radiographic progression circulating tumor DNA testing. The approval is based on data from the pivotal SERENA-6 clinical trial, which introduced a first-of-its-kind treatment strategy using ctDNA monitoring to detect emerging ESR1 resistance mutations before radiographic disease progression. Patients who switched to ETCAMAH in combination with continuing a cyclin-dependent kinase 4/6 inhibitor versus continuing treatment with an aromatase inhibitor with a CDK4/6 inhibitor following ESR1 mutation detection experienced a 56% reduction in the risk of progression or death. The trial demonstrated the clinical value of proactively identifying disease progression earlier than radiographic imaging and adapting therapy earlier in the course of disease.
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