ChromaCode, a genomics multiplexing platform company developing accessible and affordable laboratory-based solutions, signed an early access agreement with Tennessee Oncology, a nationally recognized oncology practice with 35 clinical sites of care across Tennessee and in Northwest Georgia, to test the analytical and clinical performance of ChromaCode’s HDPCR non-small cell lung cancer (NSCLC) biomarker assay. 

The NSCLC assay has complete coverage of variants identified by the National Comprehensive Cancer Network (NCCN) as clinically relevant in NSCLC and offers a streamlined workflow for rapid results, even with low sample input, while decentralizing molecular testing through cloud-based analysis, the company says.

ChromaCode’s NSCLC Assay

Recently published research in the journal Diagnostics shows the sensitivity of the NSCLC assay, even with minimal input material. The assay detected with high sensitivity DNA single nucleotide variants, insertions, and deletions, as well as RNA fusions, achieved 99% coverage of NSCLC somatic variants found in the COSMIC Mutation Database, and was highly concordant with other methods including next-generation sequencing. Tennessee Oncology will perform further studies to validate the analytical and clinical performance of the NSCLC kit.

“We conduct molecular testing for patients on a regular basis, handling over a thousand cases annually. However, challenges such as longer turnaround times when critical decisions need to be made, or insufficient tissue for sequencing, can pose significant obstacles,” says Thomas Stricker, MD, medical director for Precision Medicine at Tennessee Oncology. “Having the capability to perform in-house testing and reduce the turnaround times promises to be of great benefit to patients, particularly the 50 percent who are likely positive for one of the driver mutations with targeted treatment options.”

Further reading: Blood Tests Identify NSCLC Patients Who May Benefit from Immunotherapies

“We are delighted to announce this partnership with Tennessee Oncology; we share with them a vision and a commitment to deliver the best solutions in cancer diagnostic technology to serve the needs of patients, no matter where they live. We look forward to partnering with Tennessee Oncology on our NSCLC test now and on other molecular assays in the near future,” says Mark McDonough, CEO of ChromaCode.