The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.
PartoSure includes a noninvasive strip test that detects placental alpha microglobulin in patients and is already being used in 35 countries in Europe, the Middle East, Asia, and Latin America.
The firm plans to eventually market a direct-from-blood platform that uses infrared spectrometry to identify drug-resistant pathogens within 20 minutes.
The FDA approved its use with tissue or plasma biopsies, giving clinicians a non-invasive option to conduct a test that provides results in a day.
The test cartridge runs on the company's Unyvero platform and covers 103 diagnostic targets for various pathogens and markers of antibiotic resistance.
The firm said that its system combines many of the analytical strengths of a higher-volume instrument with the ease of a table-top analyzer.