Introducing SARS-CoV-2 Mutation Panel 1.0 by Biomeme

EDIT: As RNA viruses like SARS-CoV-2 continue to mutate, so will this panel. Please review our COVID-19 page for the latest information regarding our testing capabilities, including variant/mutation detection.

We are proud to announce our new SARS-CoV-2 Mutation Panel 1.0 (RUO) to help researchers, epidemiologists, and local, state, and federal health departments at the forefront of pandemic response detect key mutations and quickly identify the variant associated with those mutations via RT-PCR! 

Our SARS-CoV-2 Real-Time RT-PCR Test detects the SARS-CoV-2 Variants of Concern listed below, our new SARS-CoV-2 Mutation Panel 1.0 enables identification of the specific variant of concern by characterizing 9 different loci (the location of a gene in your DNA) within a positive sample, looking for key single point mutations and deletions common to certain variants.  

The Importance of Variant Surveillance  

Genetic variants of SARS-CoV-2 have been emerging and circulating around the world throughout the COVID-19 pandemic. All viruses mutate and change, and SARS-CoV-2 is no different. The emergence of variants has created a need for increased genomic surveillance to monitor what the CDC has defined as “Variants of Concern”. These are the variants of SARS-CoV-2 that have shown evidence of an increase in: 

• Transmissibility
• More severe disease (e.g., increased hospitalizations or deaths), significant reduction in neutralization by antibodies generated during previous infection or vaccination)
• Reduced effectiveness of treatments or vaccines
• Diagnostic detection failures
  

SARS-CoV-2 Variant Classifications  

Sequences with similar genetic changes are grouped into lineages, and multiple lineages can have the same substitutions. For example, the E484K substitution is found in lineages B.1.351 and P.1. Genomic surveillance efforts provide the capability to more rapidly detect and mitigate the spread of viruses that have increased transmissibility, reduced susceptibility to treatments, etc.

How It Works 

1. Test your sample using Biomeme’s SARS-CoV-2 Test. 
2. If positive result(s) detected, test the extracted sample using our SARS-CoV-2 Mutation Panel 1.0. 
3. Detect which key mutations are present and identify the variant associated with those mutations in less than an hour. 

Test Form Factors 

If you’re familiar with Biomeme, you already know that all of our assays are pre-mixed and shelf-stable in an effort to simplify and streamline the testing process. If you’re unfamiliar with us or our PCR products, below are the various form factors we manufacture for each of our tests, including our new SARS-CoV-2 Mutation Panel 1.0: 

• Go-Strips™: 3-well PCR strips designed to work with our real-time PCR thermocyclers to deliver gold standard performance anywhere. A single 3-well Go-Strip can detect all 9 mutations so you can test up to 3 samples simultaneously per PCR run. 
• Go-Plates™: 96-well PCR plates designed to work with the most common lab-bound thermocyclers, including the Bio-Rad CFX96, ABI Quant Studio 5, 7500 Fast, and Roche Lightcycler 480. A single Go-Plate™ can detect up to 32 samples for all 9 mutations or you can cut down the plate to run fewer samples at a time. 
• Bulk Vials: Designed for flexibility, our bulk vials are best for when you have non-standard PCR plastics or 384-well plates. A set of 3 bulk vials can test up to 130 samples (10uL reaction volume) for the 9 mutations of concern. 
  

Flexibility for Expansion 

As SARS-CoV-2 continues to evolve, it will be imperative for laboratories and test manufacturers to adapt as well. As new mutations and variants of concern arise, additional mutations will be added to the panel. A single PCR run on the Franklin™ can detect and differentiate up to 27 individual PCR targets. So, starting with 9 mutations, we have lots of room to grow! 

Sequencing of novel variants will allow diagnostic tests to stay updated, helping to ensure that new strains are detected. Most importantly, monitoring and sequencing these and other possible variants will ensure that tests, treatments and vaccines maintain efficacy for as long as possible. 

Pre-Order

Biomeme's SARS-CoV-2 Mutation Panel 1.0 will be generally available beginning Summer 2021 and will be sold on a first come, first serve basis. If you're interested in purchasing, please take a moment to submit this short form and a technical sales rep will follow up with you.