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Invitae is working with Bristol Myers Squibb, Janssen, Novartis, and Genentech to advance an NGS panel to gauge the efficacy of AML treatments in trials.
Adaptive is rebranding its immunoSeq Dx assay as T-Detect and plans to submit for an EUA for a COVID-19 T-Cell response test by the end of the year.
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 latest approval is immunotherapy Tecentriq's fourth indication in non-small cell lung cancer and fifth indication in lung cancer.
The consortium aims to develop assays that can detect biomarkers of pulmonary fibrosis that can be used as early indicators of a treatment's activity.
Genentech will use Adaptive's ClonoSeq assay for MRD testing in a CLL study. Adaptive will receive upfront and sample testing payments of undisclosed amounts.
Abionic will conduct all premarket process requirements for the test, while Genentech will fund the clinical and regulatory costs associated with the test.
The FDA has granted accelerated approval to Rozlytrek as a treatment for adult and adolescent patients with NTRK fusion-positive cancers.
The company is also looking to expand the use of its FDA-approved ClonoSeq assay, which has US FDA approval for MRD detection in acute lymphocytic leukemia and multiple myeloma.