PCR-based diagnostics

Clinical research has shown that the assay exhibited 100 percent sensitivity compared to culture-based testing methods, Hologic said.

The test has been validated for use with the same full set of female urogenital specimens that are used with Cobas NT/NG testing, as well as for use with male urine. 

The financing will go toward efforts by the German firm to bring its point-of-care screening system for drug-resistant bacteria to hospitals. 

The firm said that the RealTime CMV test is the only commercially available cytomegalovirus that can amplify two select regions of the CMV genome.

The firm does not meet a listing requirement calling for at least $2.5 million in stockholders equity and has 45 days to submit a plan to regain compliance.

The funding will support manufacturing of the firm's Idylla PCR-based diagnostics platform and worker training at its Mechelen, Belgium facility.

With this clearance, the respiratory pathogen panel is ready to enter the market to aid in accurate patient diagnosis for respiratory illness.