Study Demonstrates Value of ChromaCode HDPCR™ Testing for Tick-Borne Pathogens

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Sep 18, 2019, 08:00 ET

CARLSBAD, Calif., Sept. 18, 2019 /PRNewswire/ -- ChromaCode, Inc., a next-generation molecular diagnostics company using data science to significantly enhance multiplexing capabilities of life science instrumentation, today announced publication of a study by the Medical College of Wisconsin, Milwaukee Wisconsin, and Gundersen Medical Foundation, La Crosse, Wisconsin, highlighting the robust performance and expansive utility of the High-Definition PCR (HDPCR™) Tick-Borne Pathogen (TBP) Panel RUO.

The manuscript by Dr. Blake Buchan et al., titled "Evaluation of a novel multiplex high-definition PCR (HDPCR) assay for the detection of tickborne pathogens in whole blood specimens," was recently published online in the Journal of Clinical Microbiology (JCM). This multi-site study tested a combination of clinical whole blood samples and simulated samples with ChromaCode's TBP panel. Significant findings from the study include:

A total of 425 clinical specimens and 93 simulated specimens were tested with TBP in this study
For clinical samples, the TBP panel demonstrated a 100% positive percent agreement for the identification of Anaplasma phagocytophilum, Borrelia miyamotoi, Borrelia mayonii, and Rickettsia rickettsii and negative percent agreement greater than 99.8% for all nine TBP targets.
For the simulated specimens, the TBP panel demonstrated a sensitivity and specificity of 100% and 99.9%, respectively.

"The U.S. is seeing an increase in the incidence of tick-borne infections, novel pathogens that can be transmitted by ticks, and ticks harboring multiple disease agents," said Blake Buchan, Ph.D., D(ABMM), Associate Director, Clinical Pathology, Medical College of Wisconsin¹. "During this study, molecular characterization of tick-borne pathogens with a syndromic panel proved to be a beneficial adjunct to existing lab testing, enabling detection of infection in an acute stage during which serologic testing is frequently negative, as well as identifying emerging tick-borne pathogens that are not frequently tested for."

The TBP panel is ChromaCode's first commercial assay using the company's proprietary HDPCR multiplexing technology and detects nine of the most common tick-borne pathogens in a single reaction. The assay is platform-agnostic and can be performed on the most common qPCR instrumentation in laboratories around the world with no instrument modifications or additional hardware, avoiding expensive capital and service costs usually associated with multiplex testing.

The article was published online with DOI: 10.1128/JCM.00513-19 and is available here: https://jcm.asm.org/content/early/2019/08/29/JCM.00513-19.

About JCM
A journal of the American Society for Microbiology (ASM), the Journal of Clinical Microbiology publishes the most current research related to the laboratory diagnosis of human and animal infections and the role of the laboratory in both the management of infectious diseases and the elucidation of the epidemiology of infections.

About ChromaCode
Based in Carlsbad, CA, ChromaCode is redefining molecular testing through data science. ChromaCode's HDPCR™ multiplexing technology is the unique coupling of widely-used, low-cost chemistries with proprietary software using data science algorithms empowering the enormous, global installed base of real-time and digital PCR instrumentation to perform multiplex testing at a very low cost. Using HDPCR™, ChromaCode is seeking to expand global access to multiplex testing, reduce healthcare costs, and provide solutions for unmet healthcare needs faster. www.ChromaCode.com

¹Dr. Buchan serves as a consultant to ChromaCode and has received financial compensation for his services.

SOURCE ChromaCode, Inc.