Keeping you up to date on recent developments in diagnostics, including: Review highlights differences in accuracy of COVID-19 rapid tests; Likelihood of disease from hidden genetic defects; Confocal PET enables color differentiation of PET tracers in preclinical imaging.
LONDON – After the extraordinary public accusation by the National Institute of Allergy and Infectious Diseases that it published “outdated” information on the interim results of the phase III U.S. trial of its COVID-19 vaccine, Astrazeneca plc has rushed through the full primary analysis, showing 76% efficacy in preventing symptomatic disease. That is 3% lower than the headline figure in the interim data published on March 22. But with the confidence interval ranging from 68%-82%, it is consistent with the pre-specified interim analysis claim of 79% efficacy – and would appear to indicate the data safety monitoring board’s (DSMB) concern that the company, “may have provided an incomplete view,” was misplaced.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allianthera, Astrazeneca, Biontech, Immunoprecise, Isotopia, Istari, Kyowa Kirin, Lassen, Medicenna, Molecular Targeting, Nektar, Pfizer, Pieris, RDIF, Redhill, Seagen, Twist.
The FDA is becoming more amenable to screening and surveillance tests for the COVID-19 pandemic, although the distinction between test uses is not always clear. Toby Lowe, the associate director of the Office of In Vitro Diagnostics and Radiological Health (OIR), said on the agency’s weekly town hall that the difference between surveillance and screening tests is whether the individuals who are screened can act on the information thus derived.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biotia, Diazyme, Helio Health, Letsgetchecked, Mesi, Natera, Tempus, Tivic Health, Twist Bioscience.
The continuing politicization of COVID-19 vaccines is undermining medical science and the international response to the pandemic. “Vaccine nationalism is very troubling,” Jeremy Levin, chair of the Biotechnology Innovation Organization’s (BIO) executive committee, told BioWorld.
LONDON – A U.K.-wide study has found that seven out of 10 patients hospitalized with COVID-19 infection were continuing to suffer physical and mental health problems five months after discharge.
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