RTP GENOMICS

RTP Genomics LLC is a small start-up bioanalytics company founded in North Carolina in 2016 by Dr. William Kaufmann and Dr. Dennis Simpson and their business partners, Gene Howington, Tom Powers and Ted Powers that combines innovations in experimental and computational science to develop better ways to detect cancer.  RTP Genomics is located in the Research Triangle Park area of North Carolina, reflecting Drs. Kaufmann and Simpson’s ties to the University of North Carolina at Chapel Hill. Our aim is to maintain an ongoing relationship with the University for future research projects with possible commercial applications. We maintain a small core of R&D experts and have an extensive set of collaborations in industry and academia. We currently have the five partners, various contractors and consultants, and multiple research projects ongoing. We have established research partnerships with several universities, clinical research organizations (CROs), and genomic services companies including the University of North Carolina at Chapel Hill, Novogene, and Agilent Technologies. All activities will be supported by a combination of grants and future rounds of private financing

 RTP Genomics  LLC has developed the AML-MutationCounter, a genomic test for remission of AML that measures the level of residual tumor DNA in blood and bone marrow . The method involves targeted, duplex-consensus, next-generation DNA sequencing (DC-NGS) to score mutations in AML driver genes. Remission blood is compared to the primary leukemia to identify cancer driver mutations that are retained at remission  in <5% of white blood cells. Cancer-driving gene mutations are sensitive indicators of residual leukemia. The AML-MutationCounter uses commercial DC-NGS technology with proprietary bioinformatic processing algorithms to return a list of cancer driver gene mutations that are retained at remission. The presence of residual mutations at remission is an indication for further therapy. Clearance of these mutations to <0.3% mutant allele fraction (MAF) may indicate curative eradication of leukemia. Our preliminary data have shown high sensitivity for detection of mutations present at 1% mutant allele fraction, low occurrence of false positives, and, in leukemia patient samples, detection of cancer-driving gene mutations at mutant allele frequencies as low as 0.4%.

Our process aims to create a test available to oncologists, research centers and drug companies that is more sensitive than current standards, while still being cost effective enough to foster widespread adoption. These feature will improve both quality of care from end-users and qualitative analysis for researchers. Current clinical practice involves application of a flow cytometric test for residual disease at remission. The flow test is sensitive to as low as 0.01% leukemic cells in blood or bone marrow. However, recent results using genomic tests for minimal residual disease (MRD) indicate that the flow method fails to detect residual disease in a sizable fraction of patients. Thus, a genomic test for residual disease improves risk stratification and therapeutic decision-making.  Such advances in genomic oncology are the foundation for precision medicine.