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The firm said the assays detect all classes of alterations including genomic signatures for microsatellite instability, tumor mutation burden, and loss of heterozygosity.
The firm said the FDA clearance was supported by data across several lab sites and all variant classes in clinical samples from 35 tumor types.
The data from the trial will support regulatory submissions in the US and EU for Libtayo as a first-line option for PD-L1 positive non-small cell lung cancer patients.
Inivata expects to publish initial data on the assay's detection abilities in lung cancer at the American Association for Cancer Research virtual meeting in July.
Trodelvy is an antibody-drug conjugate that targets the antigen Trop-2 and is intended for metastatic triple-negative breast cancer patients who have received at least two prior therapies.
The company's PD-L1 IHC 22C3 pharmDx identifies patients with non-small cell lung cancer who qualify for first-line monotherapy with pembrolizumab.
A more accurate, integrated risk model for pancreatic cancer included not only clinical risk factors, but also blood markers and pancreatic cancer loci from genome-wide association studies.
The company has permission from US and Chinese regulators to launch human studies of its anti-Claudin 18.2 monoclonal antibody following positive preclinical studies.
The firms will evaluate Stratafide, a pan-solid tumor diagnostic test designed to identify actionable genomic alterations in tissue or blood samples.
PRGN-2009 showed anti-tumor activity in preclinical studies and now will be evaluated in humans as a monotherapy and in combination with a bifunctional fusion protein.