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.
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 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.
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.
The Scottish researchers have cofounded ClinSpec Dx to commercialize an infrared spectroscopy platform that they said may enable more precise screening for brain cancer.
Specific Diagnostics said it plans to apply CE marking to the Reveal system next year, followed by submission to the FDA for 510(k) clearance.
ProciseDx anticipates bringing rapid, quantitative point-of-care tests to market in 2020 using Lumiphore's metal luminescent reporter technology.
Chipscreen is developing a small molecule inhibitor of key serine-threonine kinases involved in tumor angiogenesis, cell mitosis, and microenvironment inflammation.
The FDA-cleared panel includes tests for salmonella, Shiga toxin-producing Escherichia coli, Shigella, Campylobacter, and Cryptosporidium.