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Thermo Fisher said the assay is the first and, so far, only FDA-approved test of its kind for a targeted treatment for RET fusion-positive NSCLC.
T2 Bio's T2SARS-CoV-2 Panel detects SARS-CoV-2 within two hours using a nasopharyngeal swab sample and runs on the firm's T2Dx instrument.
Amoy will develop its AmoyDx Pan Lung Cancer PCR Panel (9-in-1 Plus) as a companion diagnostic test for Haihe's MET kinase inhibitor Glumetinib.
The agency approved the test for use across solid tumors and with multiple companion diagnostic indications including one for prostate cancer and three for lung cancer.
The assay provides comprehensive genomic information to oncologists from a blood draw, using targeted next-generation sequencing of circulating cell-free DNA.
The targeted sequencing assay analyzes 12 genes and can be paired with the firm's BRCA gene testing kit.
Vela Diagnostics said that the RT-PCR-based test has also received provisional authorization from the Health Sciences Authority in Singapore.
The company expects to garner clearance for its platform in the US first for Lynch syndrome as it builds additional evidence for an immunotherapy application.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
To enable the use of saliva in addition to other types of samples, Sysmex requested a change to a marketing approval it obtained in March.
Novavax has begun a phase III trial of its SARS-CoV-2 vaccine, according to the New York Times.
Vox reports that the Trump Administration may limit student visas for individuals from some countries to two years.
The governor of New York says the state will conduct its own review of any SARS-CoV-2 vaccine, NPR reports.
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