Galaxy Diagnostics said this week that it has opened a clinical testing laboratory in Research Triangle Park, NC, to expand the availability of its PCR-based test for Bartonella, a difficult-to-detect species of bacteria that causes a variety of animal and human diseases, the most well known of which is cat-scratch disease.
Galaxy's new laboratory is in the Alexandria Innovation Center in Research Triangle Park, where the company moved after recently graduating from the First Flight Venture Center, a technology incubator also located in RTP.
The company's flagship molecular test, EnrichmentPCR, is built around a patented enrichment media called Bartonella alpha proteobacteria growth medium, or BAPGM, which was developed and patented by researchers at the North Carolina State University College of Veterinary Medicine.
According to Galaxy, conventional PCR testing is largely ineffective at detecting Bartonella spp. infection, especially in immunocompetent patients, and the BAPGM method enhances the growth of the bacteria up to PCR-detectable levels. The company said that the medium supports the growth and facilitates the detection and isolation of many Bartonella species in seven days rather than seven weeks for conventional methods.
"Our new facilities will enable us to meet the growing demand for our EnrichmentPCR test for Bartonella," Amanda Elam, president of Galaxy Diagnostics, said in a statement.
"The best way to know for sure if a pet is infected is to run EnrichmentPCR," Elam added. "Once detected, a Bartonella infection can be treated with antibiotics. The best way to protect people is to protect the animals they live and work with, and that means find it, treat it, and prevent the return of the bacteria."
Bartonella is increasingly implicated in a wide range of chronic health conditions affecting the central nervous system, joints, and vascular system of humans. Transmission of the bacteria from host animals is thought to occur most often by flea or tick bites and by animal bites and scratches.
Galaxy is currently seeking approval for its new laboratory under the Clinical Laboratory Improvement Act to allow it to perform tests on human blood samples. The company said it has been performing EnrichmentPCR tests on animal samples since 2009, and sees a growing market.
"Our research at NCSU has found Bartonella in cats, dogs, horses, feral pigs, and a wide range of other species," said Galaxy Chief Science Officer Ed Breitschwerdt. "In addition, our research has found a significant number of people who suffer from chronic health conditions that have tested positive for Bartonella."
"While we can’t state definitively that Bartonella caused the conditions, there is evidence that treatment to eliminate the bacteria led to improvement in the symptoms," he added. "Our new laboratory will help us expand the number of tests we can perform, and we are planning to achieve CLIA certification later this summer."