The company presented new data on the performance of a multi-pronged liquid biopsy assay in detecting colorectal cancers across a range of clinical stages.
The clinical genome-wide DNA methylation test can diagnose genetic diseases that are missed by exome or genome sequencing and evaluate variants of unknown significance.
The test uses qPCR to measure the methylation level of three bladder cancer-specific biomarkers in patient urine samples.
The team said it will partner with startup Early Diagnostics to commercialize the assay, which integrates DNA methylation analysis and computational technology.
The Israeli firm recently announced the results of a multicenter study of its Bladder EpiCheck test in addition to netting €2.5 million in EU funding to develop a lung cancer assay.
The final LCD, which expands Medicare coverage of the firm's ConfirmMDx test to all providers, becomes effective on Sept. 3.
The American Cancer Society today lowered the recommended age for screening patients at average risk for the disease to 45 from 50 years old.
The PCR-based methylation assay is intended to help predict the response of certain high-risk breast cancer patients to anthracycline-based chemotherapy.
Liquid biopsy companies are increasingly recognizing the value of analyzing not just circulating tumor DNA, but biomarkers like CTCs, methylation, and proteins.
The company's validation studies demonstrate that the assay has a 99 percent negative predictive value, which it believes will persuade physicians of its value.