PCR-Based Infectious Disease Diagnostics to Be Developed

A start-up molecular diagnostics company has raised seed money to fund clinical evaluation of its polymerase chain reaction (PCR)-based molecular assays for difficult-to-treat and drug-resistant infectious diseases.

The company is developing and validating infectious disease assays for clinical use based primarily on disease targets, genetic biomarkers, and PCR primers. It hopes to use the funding and potential grant money to out license its assays to existing in vitro diagnostic providers, who would then take the tests to market.

The company, PathoGene (Flagstaff, AZ, USA) was founded in 2008 based on technology developed by the Translational Genomics Research Institute (TGen; Phoenix, AZ, USA), in the laboratory of Prof. Paul Keim, director of pathogen genomics division and professor of microbiology at Northern Arizona University (NAU; Flagstaff, AZ, USA).

The company is developing and validating infectious disease assays for clinical use based primarily on disease targets, genetic biomarkers, and PCR primers developed in Prof. Keim's laboratory. PathoGene's assays could also be redeveloped for other molecular technologies using the same targets; however, the assays would probably remain PCR-based for the near future.

PathoGene will initially focus on assays for diagnosing methicillin-resistant Staphylococcus aureus (MRSA) infections and for determining the antibiotic resistance profile of the infection; followed by assays for diagnosing Valley fever, a fungal disease that is caused by one of two strains of Coccidioides and is isolated to the Phoenix-Tucson corridor, the California San Joaquin valley, and a few other pockets in the Southwest United States.

Diagnostic assays for Valley fever will be developed in both humans and animals; currently studies are ongoing in both clinical and veterinary environments. The company is also developing diagnostic assays for influenza, including H1N1 strains.

Todd Snowden, PathoGene's president, said that PathoGene would attempt to strike deals with companies that offer both "large-volume-type platforms" designed for more centralized diagnostic testing and newer platforms directed at "smaller community hospital-based labs, the moderate complexity and random access-type analyzers." The latter types of platforms are "really being driven into the community hospital setting because of the movement of PCR-type techniques into infectious disease.''

The US$750,000 in seed money is the first outside investment received by PathoGene, which has thus far subsisted on contributions from its founders.

Related Links:
PathoGene
TGen's
Northern Arizona University