As COVID-19 variants have emerged, so have questions about the effectiveness of tests for infection. While the risk of mutations significantly limiting their ability to detect the novel coronavirus is thought to be relatively low, companies that make COVID-19 tests are moving quickly to enhance and revalidate their products.

By mid-January 2021, the U.K., South Africa and Brazil had confirmed that “variants of concern” were driving massive surges in COVID-19 cases in their countries. Once alerted, other nations found these troubling strains rapidly multiplying within their populations as well. At the time, the world had reported 90 million cases, creating abundant opportunities for the coronavirus to mutate. Of those cases, the virus in just 360,000 had been sequenced – and nearly all of them from just a handful of countries.

It’s been more than a year since COVID-19 initially smacked humanity and as BioWorld’s senior analyst, Karen Carey, detailed in early February, vaccine and therapeutic R&D continues to move furiously forward. Variants have added a new twist in the race to gain global control of the virus. But what about tests and surveillance? Are these medical technologies keeping pace with the rapidly changing virus? BioWorld MedTech takes a deep dive in today’s edition.

• Staff Writer Meg Bryant looks for answers on whether current tests are effective when it comes to the variants and how the test makers are adapting.
• Staff Writer Annette Boyle explores how industry and universities united to scale up surveillance of SARS-CoV-2 variants.
• Senior Science Editor Anette Breindl explains why mutations in SARS-CoV-2 are at once a challenge, a fact of life and an opportunity.
• Regulatory Editor Mark McCarty highlights how governments are being challenged with keeping track of mutations while simultaneously validating new and revamped existing tests.

Personal Genome Diagnostics Inc. (PGDx) secured $103 million in a series C fundraising round led by Cowen Healthcare Investments and other stars of the med-tech investment world. Participants included Northpond Ventures, Vensana Capital, Rock Springs Capital, Kern Capital, Sands Capital, PFM Health Sciences, Windham Ventures, New Enterprise Associates, Innovatus Capital Partners, Catalio Capital Management, and others.

Diagnostic manufacturers are turning their attention to antibodies for those who have been vaccinated for the SARS-CoV-2 virus, and the U.S. FDA’s Tim Stenzel had some advice about this on the Feb. 10 testing town hall. Stenzel advised that developers think of such tests in the same vein as a companion diagnostic (CDx) in that these antibody test will have to be separately validated for each vaccine that is included in the test’s labeled claims.

Preventive medicine hasn’t always had the backing of hard data, but research into genomics at the U.S. National Institutes of Health may soon change that.

Preventive medicine hasn’t always had the backing of hard data, but research into genomics at the U.S. National Institutes of Health may soon change that. Evan Eichler of the Howard Hughes Medical Institute said on a recent NIH webinar that phased genome assembly may allow medical science to efficiently treat diseases caused by genetic disorders, but will also enable preventive medicine, the holy grail of those who seek to restrain the ever-increasing cost of medical care.

Hologic Inc. is teaming up with Google Cloud to use machine learning technologies to improve the accuracy and timeliness of cytology for cervical cancer screening. Marlborough, Mass.-based Hologic, which makes both Pap and human papillomavirus (HPV) assays, is already using artificial intelligence (AI) and machine learning in its new digital cytology platform that is available in Europe. The multiyear collaboration with Mountain View, Calif.-based Google Cloud will start with innovating that product further by enhancing the deep learning component of the system.