The COVID-19 pandemic has spurred a considerable amount of testing innovation, including more extensive use of saliva as a medium for detection of pathogens. The U.S. FDA has announced an emergency use authorization (EUA) to Yale School of Public Health for the Salivadirect testing protocol that requires no extraction of the SARS-CoV-2 virus’s RNA, a feature that Assistant Secretary for Health Brett Giroir said is “yet another testing innovation game changer that will reduce demand for scarce testing resources.”
LONDON – A large scale population study has shown that home self-testing with low-cost lateral flow diagnostics is a valid way of tracking the COVID-19 pandemic. A total of 105,651 people across the U.K. tested themselves for SARS-CoV-2 antibodies with a fingerprick blood test as part of the REACT (REaltime Assessment of Community Transmission) study.
In a controversial move, the American Cancer Society (ACS) recently recommended that people with a cervix should have a primary human papillomavirus (HPV) test every five years starting from age 25 to 65 to screen for cervical cancer. The recommendations displace the Papanicolaou (Pap) test that has formed the backbone of cancer screening for decades and extend the time between tests by two years.
TORONTO – The Toronto Stock Exchange (TSX) has accepted documentation supporting a binding letter of intent between Toronto-based Therma Bright Inc. and arm's-length vendor Orpheus Medica Inc. for development of a rapid saliva, COVID-19 test.
HONG KONG – Incheon, South Korea-based Celltrion Inc. is planning to launch two of its three rapid test kits in the U.S. as it plays its part in the global fight against the COVID-19 pandemic. Celltrion said Aug. 12 that its Sampinute COVID-19 Antigen MIA and Diatrust COVID-19 IgG/IgM rapid test kits will launch in the U.S. by the third week of August.
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.
Immunoscape Ltd. closed an $11 million global equity financing round led by U.S.-based venture firm Anzu Partners along with University of Tokyo Edge Capital in Japan, and Indonesia's NPR Holdings. The company plans to use the funds to ramp up its immune profiling technology platform, which performs deep T-cell analysis, and expand partnerships to develop vaccines for COVID-19 and other viruses as well as targeted oncology therapies.
Keeping you up to date on recent developments in diagnostics, including: GEP tests poor predictors of melanoma recurrence; A nonfasting blood test for diabetes; Starving out Chlamydia.
Much of the research on the immune response in patients with COVID-19 has focused on the humoral antibody response. Adaptive Biotechnologies Corp., on the other hand, has focused on cellular immunity to measure the T-cell response to infection with SARS-CoV-2.
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