Galaxy Diagnostics Launches the Most Sensitive Test Available for Direct Detection of Cat Scratch Disease

DURHAM, N.C. - EntSun -- Galaxy Diagnostics, Inc., the science leader in sample enrichment powered testing solutions for elusive flea and tick-borne pathogens, today announced the launch of Bartonella Digital ePCR™.  This blood-based DNA test panel provides the most sensitive direct detection of Bartonella species infections, including cat scratch disease, trench fever, involvement in culture negative endocarditis, rheumatologic disease, neurologic disease, vasoproliferative tumors, and other Bartonella-associated diseases.

The new test provides important advantages over antibody testing and conventional PCR:

• Identifies positive cases missed by IFA serology testing
• Confirms active infection via direct detection of Bartonella DNA
• Offers up to 10x more sensitive than conventional PCR
• Detects a broad range of Bartonella species in one test

Bartonella, like other flea and tick-borne pathogens, can elude conventional testing. This revolutionary new test panel combines the power of two technologies to greatly increase the likelihood of confirmation of Bartonella species infection. The patented BAPGM platform grows the low abundance organisms present in a patient sample up to detectable levels, while droplet digital PCR (ddPCR) confirms the presence of the target organism via 20,000 PCR reactions instead of a single PCR reaction.

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Published data suggests that Bartonella Digital ePCR™ is up to 10 times more sensitive than the original Bartonella ePCR™ test panel (BAPGM enrichment plus PCR) first offered by Galaxy Diagnostics. In this study supported by funding from the National Heart Lung and Blood Institute at the National Institutes of Health, Galaxy scientists reported that ddPCR sensitivity (53/112) is significantly better than qPCR (6/112) when testing patient blood and enrichment blood culture samples. Consistent with prior research, BAPGM enrichment confirmed by PCR identifies positive cases missed by antibody testing. Further research is needed to confirm clinical utility for specific presentations and disease stages of Bartonella species infection.

"Advancing the sensitivity of existing test offerings is central to our mission to bring the most scientifically advanced sample enrichment technologies and diagnostic advances to the forefront of flea and tick borne disease", said Galaxy CEO Amanda Elam. "A growing body of published research suggests that Bartonella species infections play a key role in chronic illness, from cancer involvement to heart and liver infections, especially for those individuals with high exposure to fleas, ticks, and animals. We are committed to improving the standard of diagnostic care for detection of these elusive, low abundance pathogens to ensure better patient care for those at highest risk of infection and severe disease globally."

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Galaxy advocates for a new standard of diagnostic care in Bartonellosis testing and recommends a combination baseline testing protocol using Bartonella Digital ePCR™ to confirm active infection and IFA Serology for Bartonella species to detect the presence of antibodies.

About Galaxy Diagnostics

Galaxy Diagnostics is a privately held medical laboratory located in Research Triangle Park offering the only testing solutions powered by revolutionary sample enrichment technologies for elusive flea and tick borne pathogens. The company's mission is to "Go Beyond" the limits of conventional detection by driving scientific innovation, creating new clinical knowledge through research and publication, and providing medical education and excellent customer support to healthcare providers, veterinarians, patients, and research customers in this important area of emerging infectious disease.