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.
The Vitros HIV Combo test is a fourth-generation test that detects HIV-1 and HV-2 antibodies, and the p24 antigen, resulting in earlier detections of the disease.
Bruker plans to acquire an 80 percent stake in Hain, which has capabilities in tuberculosis and mycobacteria testing as well as virology and human genetics.
