Keeping you up to date on recent developments in diagnostics, including: Improving diagnosis of pulmonary hypertension; A web-based COVID-19 assessment tool; Discovering pharmacological enzyme activators.
The U.S. FDA detailed which kinds of SARS-CoV-2 tests are getting top priority, with access to rolling, rapid reviews for emergency use authorization (EUA) during the unfolding pandemic. The agency is aiming to authorize point-of-care and at-home tests to better distribute the use of testing in various locations. It also is looking at automated and high-throughput tests that can offer analysis of larger batches of tests at one time.
PERTH, Australia – Sydney-based Speedx Pty. Ltd. has signed a global distribution deal with Roche AG, through which the latter will sell Speedx’s Resistanceplus MG and Resistanceplus GC molecular tests for detecting antimicrobial resistance to Mycoplasma genitalium (Mgen) and gonorrhea, respectively.
In a step toward what may become the new normal, at least for now, the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee is meeting virtually Wednesday and Thursday to review pediatric development plans for four cancer drugs.
HONG KONG – China and U.S.-based Lisen Imprinting Diagnostics Inc. has unveiled its Quantitative Chromogenic Imprinted Gene In-Situ Hybridization (QCIGISH) technology, a novel approach for identifying, visualizing and quantifying the biallelic and multiallelic expressions of an imprinted gene panel associated with cancer status.
PARIS – Agfa-Gevaert Group NV, of Mortsel, Belgium, has sold parts of its health care information technology (IT) business to Italy’s Dedalus Holding SpA for $1.1 billion. The divested interests include health care information solutions activities and integrated care activities in Germany, Austria, Switzerland, France and Brazil, as well as certain IT imaging activities in these territories. It represents about half of Agfa Healthcare’s business.
Policymakers in the U.S. are grappling with a disastrous pandemic as well as long-standing political tensions, but one aspect of the COVID-19 pandemic that might unify them is the need to ensure that patients in the U.S. are not at the mercy of other nations for needed diagnostics and therapies.
The U.S. FDA granted San Diego-based Illumina Inc. an emergency use authorization (EUA) for the first COVID-19 diagnostic test that uses next-generation sequencing (NGS). In addition to diagnosing infection with SARS-CoV-2, the COVIDSeq test can help researchers track mutations in the coronavirus.