FDA has granted marketing authorization to a SARS-CoV-2 test using the de novo premarket review pathway. The de novo designation went to BioFire Diagnostic's respiratory panel 2.1, which previously had emergency use authorization. The milestone marked a major turning poing in the COVID-19 diagnostics story.
Roche’s $1.8 billion proposed acquisition of GenMark Diagnostics is the latest in the growing trend of diagnostic deals occurring in 2021. Other recent M&A in the diagnostics space have included Thermo Fisher Scientific's planned acquisition of Mesa Biotech for $450 million in cash with the potential for $100 million in milestones, and three Hologic acquisitions. Hologic plans to acquire Somatex for $64 million, Biotheranostics for $230 million, and Diagenode for $159 million. All three of those deals have been announced just this year.
And in case you missed our last Medtech in a Minute report...
Companies — IVD companies in particular — won't be fooled again by a global pandemic. That's not to say there won't be another global pandemic, of course, but next time companies like Abbott will be well-prepared. Abbott has made sure of this with its newly formed Abbott Pandemic Defense Coalition, a scientific and public health partnership dedicated to the early detection of, and rapid response to, future pandemic threats. Abbott said that by connecting global centers of excellence in laboratory testing, genetic sequencing, and public health research, the program will identify new pathogens, analyze potential risk level, rapidly develop and deploy new diagnostic testing, and assess public health impact in real-time.
Cue Health has been granted emergency use authorization (EUA) for an over-the-counter COVID-19 test. The San Diego, CA-based company’s test is aimed at consumers ages 2, and older – without the need for a prescription. The molecular nucleic acid amplification test is designed to detect genetic material from the SARS-CoV-2 virus. It uses a lower nasal swab and delivers results in about 20 minutes to the user's mobile smart device. The news follows another testing breakthrough as Abbott recently received EUA for a laboratory PCR Assay that detects and differentiates SARS-CoV-2, Flu A, Flu B, and RSV in one test - and FDA EUA for Asymptomatic Usage of Alinity m COVID-19 test.
Ibex Medical Analytics is combining artificial intelligence and cancer diagnostics to improve pathology. The Tel Aviv, Israel-based company raised $38 million in a series B round to accelerate the adoption of the Galen platform, an AI-powered cancer diagnostic solution. This brings the five-year-old company's total fundraising since inception to $52 million.