More articles about Diagnostics

The Polish company recently received 9 million Polish złoty ($2.4 million) from the country's National Center for Research and Development to support its activities.

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 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.

Changes in physician behavior around monitoring patient response to therapeutic monoclonal antibodies is increasing demand for clinical testing of these drugs.

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 study authors said that many cases of drug resistance remained undetected due to inaccurate tests, resulting in more deaths from incorrect treatment. 

Proficiency testing providers told CMS last year that an update to the rule, which has not been changed since 1992, is long overdue.

Investigators calculated that the new assay, which includes 67 SNPs, could offer a 50 percent improvement over previous methods if used in newborn screening.

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 team plans to launch an RNA-seq diagnostic test out of the SickKids clinical laboratory in one year to complement clinical exome sequencing.

Pages