FDA clearance | GenomeWeb

FDA clearance

The assay has been available outside the US since November and runs on the Liaison MDX benchtop instrument. 

To develop the test, the firm said it used a library of MRSA strains collected around the world, and included components that reduce false positive results.

The firm said that molecular product sales were up 103 percent, driven by the launch of the Solana Group A Strep assay earlier this year.

The FDA has approved Merck's Keytruda as a first-line treatment for non-small cell lung cancer in patients with high PD-L1 expression. 

The test enables donor screening laboratories to use PCR-based diagnostic technology to screen donated blood and plasma.

The test uses the helicase-dependent amplification technology that underpins Quidel's AmpliVue line of molecular assays.

The firm's multi-analyte quality controls for nucleic acid tests are designed to help large and small labs mitigate quality challenges. 

The PCR-based assays run on the company's Aries system, which itself received FDA clearance in October 2015.

The M1, a lower-throughput version of the company's Aries System, can process up to six samples and six assays at a time.

It is the first FDA-approved test for the stem cell transplant use case and meets the WHO International Standard for comparable results.

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Harold Varmus, a former NIH director, says that proposed reductions to the agency's budget are worrisome.

The Genome 10K project is to sequence about 10,000 vertebrate genomes, including ones of endangered species, Digital Trends reports.

The new Coalition to Save NIH Funding aims to educate lawmakers and the public on the significance of biomedical research.

In PLOS this week: analysis of viral sequences from human blood samples, gut microbiomes of heart failure patients, and more.