Close Menu

More articles about Diagnostics

The Voyage study is designed to enroll more than 150,000 people and will follow participants for at least seven years.

The investment banks cited the company's access to proprietary technology and the potential $5 billion market for Exagen's testing options as reasons for its Outperform rating.  

The companies will develop an assay to guide treatment with a type of radiopharmaceutical therapy in patients with these rare tumors.

The company said the revenue growth was driven by growing international demand for its noninvasive prenatal testing products and services.

The Berlin-based company is the first to be designated and more NBs expect they will be designated by year end.

The test, which detects antibodies to Ebola virus from whole-blood samples and cadaveric oral fluid, was also granted breakthrough device designation.

Investigators at the Foundation for Research and Technology - Hellas, a Greek research institute, are coordinating the effort.

While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.

Fresenius was alleged to have unnecessarily tested some dialysis patients for hepatitis B surface antigen and billing Medicare for the tests.

The test, TruGraf, assesses differentially expressed genes in blood to rule out subclinical kidney transplant rejection in patients with stable renal function.

The single-cell genomics firm will collaborate with Fred Hutchinson Cancer Research Center on a targeted sequencing panel for MRD monitoring in AML.

The firm said that a new R&D plant will enable it to develop non-core testing applications that allow it to enter new markets, such as veterinary diagnostics.

The plan focuses on five scientific priorities to advance research and development over the next five years, including developing diagnostic tests for the diseases. 

The decision, which enables Medicare reimbursement, is effective for tests administered on or after Dec. 1.

Next week at the American Society of Human Genetics annual meeting, LabCorp researchers plan to present results from almost 1,000 triplet pregnancies.

The seven-gene test, ColonSentry, is designed to determine an individual's current risk for colorectal cancer relative to an average risk population.

The final guidance seeks to streamline the process, which has typically required separate submission processes for the drug and the device.

BioDirection is collaborating with CENTER-TBI, an EU initiative that aims to advance the care of patients with traumatic brain injury.

The grant will co-fund a year-long project to validate Biofidelity's chemistry to detect mutations used to guide non-small-cell lung cancer treatment.

According to the DOJ, the company also accepted a 25-year ban on participating in any federal healthcare program.

Pages