A previous analysis of CMS billing data found two contractors had seen particularly high rates of billing for tier two molecular pathology procedure codes, raising concerns about fraud.
The automated instrument has been available for research use, but its target market will be expanded to include clinical diagnostic applications in the coming months.
The interim results found the ColoAlert test had a sensitivity of 94 percent and specificity of 97 percent, with sensitivity for advanced adenoma of 80 percent.
The new study in the Journal of the American Heart Association shows that the firm's machine learning-based genetic-epigenetic approach can help diagnose coronary heart disease.
The study used the firm's HART CVE panel to stratify patients with chronic total occlusions for risk of a major adverse cardiac event.
The company currently offers a risk stratification test for Barrett's esophagus and is developing an early detection test for esophageal cancer.
The company's product revenues fell 78 percent to $14.8 million, while grant and other revenues fell 7 percent to $2.7 million.
The agency would provide reimbursement for a new set of six codes at $600 per test — a price much lower than expected.
The company's Diagnostics and Genomics segment revenues rose 4 percent, while Protein Sciences revenues were up 2 percent.
The company saw softer than anticipated demand in its life sciences business while revenue from its diagnostics segment was down 16 percent.