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The kits are the first reagents cleared by the FDA for detecting antineutrophil cytoplasmic antibodies on an automated digital IFA microscope, Inova Dx said.
Seeker quantitatively measures the activity of lysosomal enzymes that may suggest lysosomal storage diseases.
Commenters told the FDA that antigen-based rapid influenza diagnostic tests have performed poorly, and the reclassification will "mitigate" health risks.
The firm said that the push toward outcomes-based medicine will drive innovation in diagnostic wearables and smart textiles over the next few years.
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.