Applied Biocode intends to have panel for identifying 18 gastrointestinal pathogens on the clinical market by the end of the year.
Companies with diverse infectious disease diagnostic technology offerings said that molecular methods are complementary to, not competitive with traditional diagnostics.
CLIA waivers are driving the promise of MDx uptake in physicians’ offices, but achieving adoption in larger settings will remain a strategic imperative.
The firm's GI panel has also been recently evaluated in pediatric populations, demonstrating a marked increase in overall pathogen detection.
The firm also reported a 46 percent increase in molecular biology sales due to growth in its FilmArray line.
The test detects 11 viruses and three bacterial pathogens in approximately one hour and requires two minutes of hands-on time.
The study involved 11 sites and 1,560 prospectively collected patient samples and demonstrated high overall positive and negative percent agreement with comparator assays.
On an organic basis, Q1 revenues grew more than 11 percent, driven in part by strong sales of its FilmArray, Vidas, and Vitek product portfolios.
The high-throughput system is now approved with the firm's Blood Culture ID, Gastrointestinal, Meningitis/Encephalitis, and the previously approved Respiratory Panel.