The U.S. House Energy and Commerce Committee needed two days of hearings to get through a spending measure that provided the FDA with $500 million for its part in the government response. The CDC would receive $7.5 billion for vaccine distribution and tracking, all developments that ran parallel to an announcement that another 200 million doses of vaccine will be delivered by the end of July at a cost of $3.7 billion.

COLOMBIA – South Korea’s molecular diagnostics firm Seegene Inc. is expanding operations in the Brazilian market after Anvisa, the country's health care surveillance agency, cleared its multi-assay product through a COVID-19 emergency pathway. Seegene manufactures Allplex, a SARS-CoV-2/FluA/FluB/RSV test able to screen and differentiate eight targets.

Laboratory Corporation of America Holdings (Labcorp) reported its financial performance for the fourth quarter of 2020, which included a jump in revenues of 52%, a result enabled in part by its quick response to the COVID-19 pandemic. However, Labcorp said that revenues related to pandemic testing could decline by anywhere from 35% to 50% over the course of calendar year 2021.

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.