The company, established as a merger between A*STAR MedTech spin-off MiRXES and venture capital firm Venturecraft, has developed a blood test for early-stage stomach cancer.
Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify urothelial carcinoma patients who may benefit from the anti-PD1 immunotherapy.
The agency cleared Techlab's H. Pylori Quick Check, which provides results in 30 minutes, and the H. Pylori Check, a 96-well plate format test for labs that test large numbers of specimens.
Five Prime will use an IHC CDx to analyze the use of investigational drug candidates in patients with advanced gastric or gastroesophageal junction cancer.
The ctDNA assay will be used to select patients for Phase 3 of Five Prime's registrational trial investigating bemarituzumab in gastric cancer patients.
Patients with PD-L1-expressing gastric or gastroesophageal junction tumors can now be identified for potential treatment with Keytruda using Agilent's assay.
Eleven new recommendations were issued to address appropriate HER2 testing and clinical guidance in individuals with advanced gastroesophageal adenocarcinoma.
