Marketplace Overview
PrimeraDx is an emerging molecular diagnostics company developing products that will change the practice of medicine by delivering multi-gene tests that directly impact medical decision making and improve patient management and outcome. This compelling value proposition results from the use of a novel, proprietary technology called STAR (Scalable Target Amplification Routine). STAR provides a unique solution to bridge the technology gap between the current gold standard of quantitative real-time PCR analysis which interrogates single genes and semi-quantitative DNA microarrays which analyze hundreds or thousands of genes. The technology is applicable to all forms of nucleic acid analysis including gene expression, mutation analysis, micro RNA analysis, methylated DNA analysis and viral load analysis.
The STAR technology will be deployed on a fully automated instrument platform capable of quantitative, specific and sensitive analysis of upwards of 60 nucleic acid targets in a single sample. PrimeraDx will leverage this technology to address key market opportunities in infectious disease and oncology with differentiated products.
PrimeraDx’s near term strategy is focused on developing multiplexed quantitative and qualitative infectious disease assay. The first product, ViraQuant™, is a multiplexed assay providing quantitative, simultaneous measurement of 5 viruses (CMV, EBV, BKV, HHV6, HHV7) that are problematic in immune compromised patients. FungiQuant Yeast and FungiQuant Mold ™, the second and third products, are fungal panels that addresses an unmet need mycology testing where, to date, no reliable molecular tests are available. PrimeraDx’s tests will provide rapid time to results (3 hours) to interrogate for multiple pathogens with high level of sensitivity and quantification for essentially the same cost as performing a single pathogen molecular test. This high performance and highly cost effective means to assay pathogens has the ability to change the practice of medicine. It enables patient monitoring and better therapeutic choices which will translate into improved patient outcomes, and drive cost reduction in overall healthcare cost. To enable deployment of the STAR technology to research and clinical labs, PrimeraDx is developing a bench top, fully automated and high through put Integrated Capillary Electrophoresis system to perform the STAR based assays. The ICEPlex system is built for laboratories where it will integrate into existing workflow process, does not require expert training, and complies with the laboratory standards for footprint, pricing, throughput and industrial design. The platform will provide significant economic benefit by delivering multiple test results at the cost of a single test.
PrimeraDx’s longer term strategy is focused on oncology, as this represents a high growth opportunity. The medical need for improved diagnosis, monitoring and staging of disease is driving the identification and validation of new gene signatures for various cancers. The PrimeraDx platform is ideally suited to transform these gene panels into future molecular tests.