Deck: Increases in denials from insurers, uncollectible patient balances, and reimbursement pressures negatively affected company revenues.
The startup, which was founded by two Washington University researchers and a Wharton MBA, is looking to take a big bite out of Cologuard's market.
While the study showed initial promise, further work will be necessary to clarify its performance for various clinical indications.
The assay's CE marking permits its use for the early diagnosis of HIV-1 in infants and for measuring viral load and disease progression using dried blood spot samples.
The test measures a number of protein biomarkers, including a proprietary antibody, to diagnose prostate cancer and determine its aggressiveness.
The company plans to use the funds to support development of an early cancer detection test and expansion of its CDx sales force.
As part of the agreement, LifeLabs will serve as an exclusive distributor for MDxHealth's non-invasive liquid biopsy prostate cancer assay In Canada.
Cardiac immunoassays paced revenue growth in Q4. The firm also saw an 88 percent jump in total revenues for 2018, supported by 43 percent growth in molecular diagnostics.
The joint venture, called Renx AI Labs, will allow RenalytixAI to operate outside New York City and perform prospective revenue-generating contract research.
Proficiency testing providers told CMS last year that an update to the rule, which has not been changed since 1992, is long overdue.
The assay, which uses the Bioneer ExiStation molecular diagnostics instrument, was also recently registered for purchase by the Global Fund.
The partners anticipate developing tests that analyze clusters of biomarkers to detect cardiovascular disease, kidney disease, liver cancer, and other diseases.
The new grant from Innovate UK will fund development of a sample preparation system to support POC infectious disease pathogen detection.
The federal government said GenomeDx billed Medicare for its Decipher Biopsy prostate cancer genome classifier on behalf of patients who didn't need the test.
The firm said that it anticipates using the funds to scale operations in the US and to continue rolling out its service in the UK.
The FDA also cleared a 23andMe genetic health risk report for a syndrome associated with a higher risk of developing hereditary colorectal cancer.
The assay is designed to detect ribosomal RNA from four clinically relevant Babesia species and runs on the company's Procleix Panther system.
PAMA, divestitures, and weather were among the factors negatively affecting revenues in the company's diagnostic division.
The firm used about $38.8 million on Feb. 1 to repay all outstanding principal, interest, related fees, and other obligations under an existing loan agreement.