With the certification, the Silicon Valley-based company aims to roll out its AvaGen test for keratoconus and corneal dystrophies beginning this quarter.
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.
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 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.
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.
Acquired epilepsy is a form of the neurological disorder that results from other conditions such as stroke, infections, and traumatic brain injury.
The FDA gave the nod to Shenzhen Bioeasy Biotechnology for two lateral flow immunoassays that provide preliminary results in detecting marijuana in urine.
The system, which was launched in Europe earlier this year, helps eliminate preanalytical errors by automatically detecting patient tube parameters.
The firm said that its newly CE-marked test for intestinal infections is suitable for use in laboratories and hospitals, and provides results in 90 minutes.
The company's Acucy Influenza A&B test detects viral nucleoprotein antigens from nasal and nasopharyngeal swabs.
ProciseDx anticipates bringing rapid, quantitative point-of-care tests to market in 2020 using Lumiphore's metal luminescent reporter technology.