The U.S. FDA announced July 18 that it has granted an emergency use authorization (EUA) to Quest Diagnostics Inc. for the company’s real-time, reverse transcriptase polymerase chain reaction test for the SARS-CoV-2 virus in a development that FDA commissioner Stephen Hahn described as “an important step forward.”
Commercial continuous glucose monitors (CGMs) require some access to a patient’s blood, typically through tiny needles embedded in a wearable patch sensor. But Movano Inc. is working to develop a CGM that is based on radio frequency technology to monitor glucose levels via a noninvasive, external wearable, likely in a form factor akin to a watch or a wrist-worn fitness wearable.
HONG KONG – Incheon, South Korea-based Celltrion Inc. will start manufacturing its COVID-19 treatment for clinical trials and commercial distribution, even though it’s only reached phase I.
The Xpert MTB/XDR test developed by the Foundation for Innovative New Diagnostics (FIND) and Cepheid Inc. quickly indicates whether a patient has a dangerous – and rapidly increasing – strain of multidrug resistant tuberculosis (TB). The new test enables clinicians to return results in 90 minutes and see immediately whether the pathogen would respond to standard first- or second-line therapies.
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.
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