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FDA clearance

The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.

The approval of its Omics Core assay for tumor-normal mutational profiling opens the door for payor reimbursement, which is key to reaching profitability, NantHealth said.

The in vitro diagnostic test can deliver molecular results from whole blood samples in less than three hours, the company said. 

The FDA clearance follows earlier US marketing approval for the firm's C. Difficile assay.

The agency has approved the use of Exact's Cologuard test for average-risk individuals aged 45 and older.

The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions. 

The clearance of the Binx io CT/NG test marks a milestone for the Johns Hopkins University group that funds early-stage development of rapid STI testing.

The Frederick, Maryland-based firm has received regulatory clearance for a multiplexed array-based assay after more than 15 years in development.

Applied BioCode said that it now has access to higher volume laboratories that use the Roche MagNa Pure 96 System for sample extraction.

The assay is for detecting varicella-zoster virus in cerebrospinal fluid and can be used with the firm's Liaison MDx instrument.

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The Washington Post reports that the CDC's SARS-CoV-2 test issues reflect earlier ones it had with Zika virus testing.

NPR writes that even with thousands of new COVID-19 papers, each should be evaluated based on its own quality.

Researchers traced a gene cluster linked to COVID-19 severity to Neanderthals, the New York Times reports.

In PNAS this week: soil bacteria-derived small molecules affect centrosomal protein, microfluidics approach for capturing circulating tumor cells, and more.