The firm's lead product is a blood-based assay, called Alibrex, which uses PCR technology to monitor stage IV solid tumor cancer therapy.
The American Society of Breast Surgeons updated consensus guidelines to recommend multigene panel testing for patients with cancer, including those who were tested many years ago.
The investment bank said the company is strongly positioned as a leader in the transplant diagnostics market with tests that serve an unmet need.
Decipher — formerly GenomeDx Biosciences — will help Dendreon identify patients who are likely to respond to its prostate cancer therapy Provenge.
The test is for monitoring treatment response in chronic myeloid leukemia and uses a new Droplet Digital PCR instrument.
The firm's CTO Sarah Levy said the Series C funding will enable it to expand R&D activities to develop applications beyond complete blood counts.
Deck: Increases in denials from insurers, uncollectible patient balances, and reimbursement pressures negatively affected company revenues.
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.
An analyst said the DetermaVu test could potentially be best in class for lung cancer diagnosis and that CMS could begin reimbursing for it in late 2020.
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 company will use proceeds to support commercialization of its lung cancer liquid biopsy test, and to fund studies to cement reimbursement and adoption.
Biocept is offering 6.25 million shares of its common stock and warrants to purchase up to 6.25 million shares of the common stock at a combined price $1.20 per share and warrant.