NEW YORK (GenomeWeb News) – Molecular diagnostics company DxNA has received a $2.5M equity investment from an unnamed individual investor.
DxNA will use the funds to move two of its products through the US Food and Drug Administration regulatory process, according to a statement released earlier this week.
The company intends to use the investment to complete the regulatory process for FDA 510(k) clearance of its valley fever assay, a PCR-based diagnostic of Coccidioidomycosis infection. Coccidioidomycosis is a soil-dwelling fungus endemic to the southwestern US. When inhaled, the fungus causes a flu-like syndrome and respiratory infection called valley fever, which was diagnosed in 20,000 people in 2011, according to the US Centers for Disease Control and Prevention.
There are currently no FDA-approved PCR-based assays for diagnosing Coccidioidomycosis infection, according to DxNA.
The investment will also be used to initiate the regulatory process for the company's PCR-based MRSA assay. This test detects and differentiates Staphylococcus aureus and coagulase negative Staphylococcus, and can determine if either has the methicillin resistance gene, mec-A.
Both tests are run on the company's portable real-time PCR diagnostic system, called GeneSTAT, which obtained the CE mark in 2011.
In May of this year, DxNA licensed the rights to the Staph assay from Pathogene, a spinout company of the Translation Genomics Institute and Northern Arizona University. It followed that licensing deal in July by announcing its planned acquisition of Pathogene, which is expected to close in the coming weeks.