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.
The company also reaffirmed its guidance for the fourth quarter, and continues to expect revenues of $46.5 million to $48.0 million and EPS of $.09 to $.11.
The company plans to launch on the platform tests for diagnosing sexually transmitted diseases and for distinguishing between viral and bacterial infections.
As part of the deal, which is worth at least $3 million for the first five years, Primerdesign will develop and supply 384-well plate molecular assay panels for Genesis.
