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The agency approved Agilent/Dako's PD-L1 IHC test for identifying TNBC patients who are most likely to respond to Keytruda and chemo.
The company's goal is to help laboratories and smaller diagnostic firms accelerate test development and provide end-to-end test design assistance.
The firm beat the consensus Wall Street estimate on the top line but fell short of the estimate on the bottom line.
The test will use a blood-based biopsy to detect patients with BRCA1, BRCA2, and/or ATM alterations in metastatic castration-resistant prostate cancer.
Roche's real-time PCR test detects defined mutations of the epidermal growth factor receptor gene in DNA from non-small cell lung cancer patients.
FoundationOne Liquid CDx can now be used as a companion diagnostic for therapies to treat advanced ovarian, breast, and non-small cell lung cancer.
The test analyzes substitutions, insertion and deletion alterations, and copy number alterations in 324 genes, along with some genomic signatures in solid tumors.
The test confirms the presence of antibodies directed to various gene products of HIV-1 and HIV-2 in human serum or plasma.
The Italian diagnostics firm believes its test can ID patients with high viral loads rapidly who need to be treated quickly.
The test detects the presence of two biomarkers within a single cell associated with HPV infections that can progress to cervical cancer.