The next phase of testing for the COVID-19 pandemic will hopefully include the roll-out of tests for neutralizing antibodies for the SARS-CoV-2 virus, but there are some roadblocks. The FDA’s Tim Stenzel said the agency has a limited amount of information to offer regarding emergency use authorizations for these tests, a predicament that might not resolve until several applicants are in and the agency can see some information that will aid in development of performance and validation standards.
Diversified health care player Abbott Laboratories did better than expected when it reported second quarter earnings. The Abbott Park, Ill.-based company is one of the earliest to start reporting for this period, which in the U.S. was characterized by an initial heavy impact from the ongoing pandemic.
Keeping you up to date on recent developments in diagnostics, including: Predicting likelihood of rare disease; X chromosome is finished; Cotesting improves detection of cervical cancer; Single-cell studies give insights into pulmonary fibrosis.
In its first fully virtual markup session, the House Energy and Commerce Committee Wednesday set aside politics to approve a bill that would make the U.S. Strategic National Stockpile (SNS) a better emergency resource – at least for the next few years.
Glympse Bio has closed an oversubscribed $46.7 million series B financing, with an eye toward boosting its novel biosensor platform in fibrotic diseases, including nonalcoholic steatohepatitis (NASH), oncology and infectious diseases.
Researchers around the globe are still struggling to understand the basic biology of COVID-19 infection, including how it works in the body and how to most effectively combat it. To aid them in their efforts under the weight of the ongoing pandemic, single-cell research tool company 10x Genomics Inc. has launched an updated version of its Chromium Single Cell Immune Profiling product.
Endpoint Health Inc. has made its official debut, scooping up $12 million in debt and equity financing from a host of investors, including Mayfield, Y Combinator, Ame Cloud Ventures and Wireframe Ventures. The Palo Alto, Calif.-based company is focused on helping people with illnesses such as sepsis and acute respiratory distress syndrome (ARDS) – life-threatening conditions often caused by serious infections, including COVID-19.
Thermo Fisher Scientific has joined forces with First Genetics JCS to commercialize next-generation sequencing (NGS) diagnostics in Russia. The agreement allows Moscow-based First Genetics to bring its F-Genetics NGS system and in vitro diagnostic assays for reproductive health testing to Russian labs.
New England Biolabs Inc. (NEB) has launched its research use only product that can be utilized for the detection of the novel coronavirus, SARS-CoV-2 RNA. It is intended to serve as an alternative to RT-qPCR, enabling visual detection of amplification of SARS-CoV-2 nucleic acid in half an hour.
The U.S. Preventive Services Task Force (USPSTF) may recommend a fairly dramatic expansion of the populations that would be eligible for coverage for lung cancer screening, a bit of news that might be expected to cheer makers of CT imaging systems. However, compliance with the existing recommendations is already quite low, suggesting that an expansion of eligibility is likely to exert a negligible effect at best on utilization.