As of the end of January, SARS-CoV-2 has demonstrably infected more than 100 million individuals globally. It has killed more than 2 million. And the long-term sequelae of COVID infections – to say nothing of the health consequences of grief, social isolation and widespread economic distress – are still unfolding and will be for years to come.
Thermo Fisher Scientific Inc. has inked a definitive agreement to acquire Mesa Biotech Inc., a privately held molecular diagnostics company with a point-of-care (POC) platform, for approximately $450 million in cash. The scientific instruments and testing giant said it will pay an additional $100 million in cash upon the completion of certain milestones. The planned acquisition will expand Thermo Fisher’s franchise of diagnostic test options with a novel platform that enables nucleic acid polymerase chain reaction (PCR) testing at the point of care.
The U.S. FDA is actively working on guidance for conversion of emergency use authorizations (EUAs) to conventional premarket review programs, but the FDA’s Tim Stenzel said he does “not perceive a need to rush to convert EUAs” because of the volume of EUA applications, and because he does not expect the public health emergency “to end anytime soon.”
Thermo Fisher Scientific Inc. launched a new cell therapy processing system that overcomes many of the hurdles that have kept promising cell therapies from reaching commercialization. The modular, closed system increases cell processing efficiency and reduces associated costs.
The Lung Cancer Genomic Screening Project for Individualized Medicine in Asia (LC-SCRUM-Asia) has partnered with Thermo Fisher Scientific Inc. to speed molecular profiling in two major studies. The project now uses Waltham, Mass.-based Thermo Fisher’s Ion Torrent Genexus system and Oncomine Precision assay as the sole system for conducting next-generation sequencing (NGS) to improve personalization of therapeutic approaches and better understand drug resistance in non-small-cell lung cancer (NSCLS).
Thermo Fisher Scientific Inc. released updated software and new instructions for its Taqpath COVID-19 Combo Kit, a widely used COVID-19 test kit that is also the basis for several other coronavirus diagnostics, following issuance of a letter to clinical laboratory staff and health care providers by the U.S. FDA about the risk of false results with the test. Separately, the Waltham, Mass.-based company has released the first in a series of hematology-oncology assays designed to run on its Ion Torrent Genexus system.
It was one of the largest med-tech deals of the year. However, Qiagen NV shareholders were apparently not satisfied by Thermo Fisher Scientific Inc.’s offer, with the voluntary public takeover bid not achieving the minimum 66.67% acceptance threshold. A total of 47% of the outstanding Qiagen shares were tendered into the offer of €43 (US$50.95) at the expiration of the acceptance period Aug. 10.
Thermo Fisher Scientific expanded its Globalaccess Sequencing Program to include oncology laboratories in addition to research labs working on COVID-19 studies. The company will subsidize a limited number of Genexus systems to help pathology laboratories around the world.
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.
Thermo Fisher Scientific Inc. is working with Daiichi Sankyo Co. Ltd. to develop a companion diagnostic (CDx) to identify non-small-cell lung cancer (NSCLC) patients with human epidermal growth factor receptor 2 (HER2) mutations who could be eligible for the Tokyo-based company's cancer drug, Enhertu.
