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The Cobas vivoDx MRSA test uses new bacteriophage technology based on bioluminescence to detect bacterial colonization in nasal swabs.

The company is using the test to direct patient enrollment and treatment stratification in a trial of pembrolizumab (Keytruda) combination treatments.

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

Of the 28 companies in the index, 21 companies' share prices increased while the share values of 7 declined month over month. 

The financing will go toward building out its sales teams in the US and Europe in order to market its multiplexed MDx tests for infectious diseases.

The company also said that it expects a clearance decision from US regulators in the near term on a lower respiratory tract infection test that runs on its Unyvero system.

The company's point-of-care platform combines clinical chemistry, immunoassays, and hematology technology to run a range of diagnostic tests. 

 

Since FDA's actions, the company has implemented a program in which customers must sign a certification letter saying they are using its products as intended.

Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.

Despite the step-up in FDA action against labs offering PGx tests, the success of these programs suggests that access to them isn't being stifled as some feared.

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