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FDA clearance

The FDA approved the real-time PCR-based test for use on the Cobas 6800 and 8800 systems to assess the response of transplant patients to treatments. 

The GenePOC GBS LB assay uses real-time PCR technology to detect GBS colonization from lim broth samples with sensitivity of 95.9 percent and specificity of 95.5 percent. 

The test on the Alinity platform is for use in the POC or clinical laboratory setting, and for the quantitative measurement of glucose in arterial and venous whole blood.

Recent action from the FDA to reclassify certain point-of-care flu diagnostics means the agency will keep a closer eye on the tests' sensitivity and specificity.

The real-time PCR, sample-to-answer assay provides surveillance of whooping cough, a contagious respiratory disease, in clinically symptomatic patients.

The Ventana PD-L1 assay was approved as a complementary diagnostic for bladder cancer patients being considered for treatment with the immunotherapy Imfinzi. 

According to Roche, the module "offers greater testing efficiency, superior reagent management, and industry-leading turnaround time for critical diagnostic tests."

The homogenous immunoturbidimetric PCT assay can be used on most clinical chemistry analyzers to measure procalcitonin levels in serum and plasma samples.

The clearance is the first by the FDA for a whole-slide imaging system for reviewing and interpreting digital surgical pathology slides prepared from biopsied tissue.

Alere said that it will promptly apply for a CLIA waiver for use of the Alere Reader and the in vitro immunochromatographic influenza assay.  

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