It is the first FDA-approved test for the stem cell transplant use case and meets the WHO International Standard for comparable results.
The software connects Luminex's FDA-cleared Aries PCR-based platform with its multiplex xMap technology-based Magpix system.
With this clearance, the respiratory pathogen panel is ready to enter the market to aid in accurate patient diagnosis for respiratory illness.
At the San Antonio Breast Cancer Symposium, a Sividon collaborator is scheduled to present a new study including a comparison between EndoPredict and Oncotype DX.
The test is used to identify NSCLC patients for whom treatment with Tarceva in first-line therapy and Tagrisso in second and subsequent lines of therapy may be effective.
Before patients receive the Cotellic/Zelboraf combination, patients should be tested with an FDA-approved BRAF mutation companion test, the agency said.
The German molecular diagnostics firm has adjusted its 2015 outlook in response to the FDA letter.
The complementary diagnostic for Bristol-Meyers Squibb's Opdivo is the firm's second test to receive FDA approval this month. The first was for Merck's Keytruda.
The test is for determining whether a patient's tumor expresses the PD-L1 protein and is likely to respond to Merck's drug Keytruda, which the FDA also approved today.
The test was approved for use with Iressa to determine those patients who would benefit by being treated with the drug.
The US National Institutes of Health's All of Us project awarded $4.6 million to the company Color to develop a genetic counseling resource for the program.
The Times of India reports on a pilot study that used genomic testing to determine whether patients had drug-resistant tuberculosis.
New guidelines say that more women may benefit from genetic testing for hereditary breast or ovarian cancer, according to the Los Angeles Times.
In Cell this week: small proteins identified among human microbiome, role for tumor microbes in pancreatic cancer survival, and more.