Widespread and scalable surveillance of the SARS-CoV-2 virus on a national basis won’t be possible if identification of the variants and subvariants that keep popping up remains a game of Whac-a-Mole. But help may be on the way. Thermo Fisher Scientific announced that it has teamed with Helix and Rosalind, Inc. on a National Institutes of Health (NIH)-supported project to develop a new SARS-CoV-2 genotyping method allowing for more rapid identification of virus variants.

The Strategic Opportunity

Current detection and tracing of new CoV-2 variants is based on next-generation sequencing (NGS), with roughly 5 percent of randomly selected positive samples in the US sent for variant identification. The problem with NGS is that it’s slow, taking up to 21 days from the date of positive result for variant data to become available in public repositories. Widespread adoption of genotyping-based identification would be much faster, not to mention cheaper since it would enable labs to reduce costs for strain subtyping required for NGS, allowing for classifying a high percentage of positive samples and provide information in just two or three days. Samples that can’t be assigned to a known variant via the genotyping approach would then become prime suspects for new variants. Large numbers of such samples would send up a red flag that a new variant might be emerging and give test and vaccine makers time to analyze and adjust their products accordingly.

The NIH RADx Project

Funded by the NIH Rapid Acceleration of Diagnostics (RADx) Initiative, the Thermo Fisher/Helix/Rosalind project utilizes a polymerase chain reaction (PCR)-based genotyping method that any test lab performing real-time PCR testing can use. Labs can use the Rosalind Tracker website to make the data generated publicly available. “Our approach makes it possible to conduct surveillance testing on a significantly larger number of samples and quickly determine which variant is present in a sample,” said Dr. Eric Lai, one of the co-lead investigators, in a statement. The collaborators used Rosalind’s cloud-based data analytics platform to create a centralized tool that labs can use to aggregate and analyze the data in a real-time dashboard format offering a snapshot of the most current virus strains circulating the country. Thermo Fisher’s role: Supply the tests by updating its TaqMan SARS-CoV-2 Mutation Panel research-use only assay to include the four markers that can detect the Omicron and Delta variants with high precision. Population genomics and viral surveillance company Helix validated the technology. “Our challenge has been staying in front of this pandemic at the rate the virus is evolving,” noted Rosalind CEO Tim Wesselman in a press release. “We’ve demonstrated an approach for maintaining highly accurate markers, rapidly implementing marker updates in manufacturing, and quickly deploying these assays to nationwide testing labs for validating COVID-19 positivity with lineage assignment.” Here’s a summary of some of other key strategic diagnostic deals announced in March 2022:

Strategic Alliances, Partnerships, & Collaborations

Distribution, Sales, & Marketing Agreements

Licenses

Government Contracts