Some at-home infectious disease tests and sample collection kits exist in a murky regulatory realm, and their sale to patients is troubling laboratorians and clinicians.
The firm said its new molecular platform, which offers random-access testing, high throughput, and a broad menu has the potential to replace multiple instruments in molecular labs.
The Austin, Texas-based company offers more than 30 tests, including those for food sensitivity, fertility and women's hormones, sexually transmitted diseases, and thyroid.
An early user of a new Mycoplasma genitalium and antibiotic resistance test from SpeeDx that uses the Xpert cartridge shared some initial validation data.
The FDA said it is the first test authorized to test for M. genitalium, a slow-growing bacteria that is difficult to detect with traditional laboratory methods.
