NEW YORK – The US Food and Drug Administration last week revoked Abbott’s Emergency Use Authorization for its BinaxNow COVID-19 Ag Card 2 Home Test upon the company’s request. The EUA was granted on March 31, 2021, and amended on Sept. 23, 2021, and Jan. 7, 2022. Abbott requested for the EUA to be revoked on Feb. 21 because the authorization “is no longer required, in consideration of Abbott’s product available under another EUA issued to Abbott,” the FDA said on its website. The FDA added that no tests were distributed under the EUA.
Laboratory Corporation of America last week disclosed in its Form 10-K that it paid $400 million for the purchase of Ascension, a Catholic, nonprofit health system. Labcorp had announced the acquisition last month.
Pacific Biosciences said this week that it is supporting Canada's Hospital for Sick Children (SickKids) in using HiFi whole-genome sequencing to identify genetic variants associated with medical and developmental conditions. SickKids will examine samples that were previously analyzed with short-read sequencing but where the analysis did not identify a disease-causing variant.
Scottish microarray technology company Arrayjet said this week that it has formed a US subsidiary of the same name that will support US customers in research, pharma, and diagnostics. The company sells liquid handling and bioprinting equipment based on its patented, non-contact inkjet technology and offers contract research and manufacturing services for microarray and high-throughput screening applications.
Indian genomics company Mapmygenome said this week that it opened a new laboratory, called the Genomics Experience Center, in Bengaluru on March 1. The new center, which is certified by the National Accreditation Board for Testing and Calibration Laboratories and the Indian Council of Medical Research, will provide genetic testing, genetic counseling, blood tests, health screening tests, antibody tests, and COVID-19 RT-PCR tests and will complement Mapmygenome's existing laboratory services in Hyderabad and Delhi. The company's flagship product, Genomepatri, analyses an individual's DNA to assess genetic risk for certain conditions, drug efficacy, and drug sensitivities.
AltPep said this week that it has received US Food and Drug Administration breakthrough device designation for its blood-based Soba-AD diagnostic test to detect Alzheimer’s disease. The company said the test, which is in development, detects toxic forms of amyloid-beta peptides at the early stages of the disease and has the potential to detect Alzheimer’s early, including before symptoms arise.
BioEcho Life Sciences, a German nucleic acid purification and sample prep company, this week announced a minority investment from Ampersand Capital Partners. Financial details were not disclosed. In a statement, BioEcho said it will use the funding to support the launch of several new kits and expand its direct sales force, among other worldwide growth initiatives.
Mission Bio said this week that its first center of excellence, aimed at developing best practices for integrating its Tapestri platform into solid tumor research, will be located at Memorial Sloan Kettering Cancer Center. Jorge Reis-Filho, MSK's director of experimental pathology, will run the center. His lab plans to develop academic and industrial best practices using single-cell DNA profiling to observe tumor heterogeneity and clonal architecture in solid cancers. His team will work closely with Mission Bio’s R&D team to improve nuclei extraction protocols, roll out new virtual panel content for BRCA-mutant cancers and other cancer types, and enhance copy number variation analysis.
Caris Life Sciences said this week that the Tampa General Hospital Cancer Institute has joined the Caris Precision Oncology Alliance, a worldwide network of cancer centers that collaborate to advance precision oncology and biomarker-driven research. The network now comprises 59 cancer centers and academic institutions. Members have early access to Caris' database and artificial intelligence platform to establish evidence-based standards for cancer profiling and molecular testing in oncology.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.