Illumina (Nasdaq:ILMN) announced today that it plans to appeal the Federal Trade Commission’s (FTC) decision over its acquisition of Grail. The FTC today announced that it finds the $7.1 billion acquisition “likely to substantially reduce competition” in the U.S. It would affect the research, development and commercialization of cancer tests, FTC said. In its decision, […]
Genomics/Molecular Diagnostics
Illumina launches cloud-based next-gen sequencing software
Illumina (Nasdaq:ILMN) announced today that it released its Connected Insights cloud-based software for next-generation sequencing (NGS). San Diego-based Illumina designed Connected Insights to streamline interpretation and reporting from a range of assay types. This enables labs to scale the use of NGS. They can also reduce turnaround times for clinical reporting by integrating third-party knowledge […]
BD wins FDA clearance for high-throughput infectious vaginitis diagnostic
BD (NYSE:BDX) announced today that it received FDA 510(k) clearance for its Vaginal Panel diagnostic on the COR system. The comprehensive diagnostic test directly detects the three most common infectious causes of vaginitis. It uses the BD COR, the company’s high-throughput molecular diagnostic platform for large laboratories. Franklin Lakes, New Jersey-based BD originally received marketing […]
PerkinElmer divests businesses, becomes life sciences and diagnostics company
PerkinElmer (NYSE:PKI) announced today that it completed a divestiture of its applied, food and enterprise service businesses. Waltham, Massachusetts-based PerkinElmer divested these businesses to investment firm New Mountain Capital. This results in a new, high-growth life sciences and diagnostics business at PerkinElmer. According to a news release, the businesses focuses on developing and delivering novel […]
FDA clears Abbott’s blood test for concussion
Abbott (NYSE:ABT) announced that it received FDA clearance for the first commercially available laboratory traumatic brain injury (TBI) blood test. The test, now widely available to U.S. hospitals, runs on the Abbott Alinity i laboratory instrument. It provides clinicians with an objective way to quickly assess mild TBIs, otherwise known as concussions. Abbott said in […]
How the BD diagnostics business is driving greater access to care
It’s been a busy time for BD, with recent approvals further driving the company’s diagnostics business forward. Dave Hickey and BD (NYSE:BDX) have their sights on what they call “transformative forces.” These forces could change the delivery of healthcare going forward. Hickey, EVP and president of the Life Sciences segment at BD, said these forces […]
FDA approves BD HPV assay for use with Hologic ThinPrep Pap test
BD (NYSE:BDX) announced today that it received FDA approval for its Onclarity HPV assay for use with the ThinPrep Pap test. The ThinPrep Pap test, developed by Hologic (Nasaq:HOLX), offers Pap and HPV testing from one vial. It accompanies the BD SurePath liquid-based Pap test vial as the most commonly used vials by labs in […]
Exact Sciences launches cancer therapy selection test
Exact Sciences (Nasdaq:EXAS) announced that it launched its OncoExTra cancer therapy selection test in the U.S. OncoExTra is a next-generation sequencing, comprehensive DNA- and RNA-based genomic test. Madison, Wisconsin-based Exact Sciences designed it to provide doctors and patients a complete molecular picture of the patient’s cancer. The test provides reliable and actionable results personalized to […]
FDA authorizes BD’s combo COVID-flu-RSV test
BD (NYSE:BDX) announced today that it received FDA emergency use authorization (EUA) for a COVID-19, flu and RSV combination diagnostic. The company designed the molecular test to detect SARS-CoV-2, influenza A and B and respiratory syncytial virus (RSV). It’s used on the BD Max molecular diagnostic system. The test uses a single nasal or nasopharyngeal […]
FDA extends shelf life of some popular COVID tests
The FDA announced today that certain COVID-19 diagnostic tests under emergency use authorization now have a longer shelf life. Diagnostics made by Abbott, Maxim Biomedical and iHealth Labs all received extensions for their expiration dates. The Abbott BinaxNow COVID-19 antigen self-tests now have a shelf life of 22 months. Previously, the popular test had a […]
FDA clears new sepsis diagnostic from Cytovale
Cytovale announced today that it received FDA 510(k) clearance for its IntelliSep test for the early detection of sepsis. San Francisco-based Cytovale designed IntelliSep to provide test results in under 10 minutes. The emergency department-focused tool helps clinicians recognize sepsis and make time-sensitive critical decisions. It provides actionable answers directly from a standard blood draw. […]