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FDA clearance

Mobile apps could one day transform the way diseases are diagnosed, but concerns have been raised about their accuracy and safety.

The firm said that it is the first point-of-care diagnostic test available in the US to detect a potentially fatal disease that affects around 8 million people globally.

The firm said that its analyzer and intelligent quality management system enhance the efficiency of testing and reduce the total cost of care.

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 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.

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