FDA approved Foundation Medicine's companion diagnostic test for solid tumors, making it the first of its kind on the U.S. market.
IVD - News
FDA approved the Roche cobas Zika as the first commercially-available blood donor screening test for Zika virus.
Angle, a cell diagnostics company with a novel harvesting technology for circulating tumor cells and megakaryocytes, inks two major agreements, including a co-marketing partnership with Qiagen.
Education and additional rapid diagnostics are needed to help save lives, say advocates. Daphne Allen Deaths from antimicrobial resistance (AMR) could reach 10 million annually by 2050, fears a new industry alliance. Diagnostics manufacturers (along with those developing pharmaceutical...
The 60-second rapid HIV test, INSTI, receives innovative technology award. HIV-positive patients may not always know they are infected. Routine screening has been a challenge, but one potential solution has just won an innovative technology award and a group purchasing contract with one of the...
The scorned blood-test company cuts hundreds of jobs and moves its focus to its miniLab testing platform as it struggles to rebuild its reputation.
The agency has issued draft guidance detailing its oversight of next-gen sequencing devices used to diagnose infectious diseases.
FDA has approved Abbott's companion diagnostic to detect a specific gene deletion in certain leukemia patients, part of its pairing with a drug intended to treat such populations.
In a new subanalysis, results of a blood test are found to be correlated with cardiovascular event rates, potentially offering a way to classify coronary artery disease patients by risk of future events.
Concussion symptoms aren’t always immediate, but study results have shown a particular biomarker can be found in a patient’s blood for as long as a week.
Invitae announces new panels for pediatric, rare diseases, neuromuscular, and inherited metabolic conditions, taking its coverage well beyond oncology to more than 1000 genes.
A study of over 10,000 patients tested with a multigene hereditary cancer panel finds that the approach commonly spots hereditary cancer-linked gene variants that single gene tests might miss.
In recent months, genetic testing company Invitae has dramatically expanded its test menu, focusing on diagnosing disease using a broad platform.
The development of biologic-delivery devices requires input from the materials science, biology, chemistry, toxicology, biomedical, mechanical engineering, and other disciplines