Biomeme SARS-CoV-2 Test Approved by FDA Under Emergency Use Authorization

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Biomeme’s end-to-end SARS-CoV-2 Test uses gold standard Real-Time RT-PCR to assist in the diagnosis of COVID-19 in as little as an hour.

Biomeme's End-to-End SARS-CoV-2 Real-Time RT-PCR Test

Biomeme's End-to-End SARS-CoV-2 Real-Time RT-PCR Test

Biomeme, Inc. announced today that the U.S. Food and Drug Administration (FDA) gave Biomeme’s SARS-CoV-2 Real-Time RT-PCR Test Emergency Use Authorization (EUA) for use in any lab CLIA-certified to perform high complexity testing. It is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

About Biomeme’s SARS-CoV-2 Test

The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is designed to detect the virus’ Orf1ab and S genes in nasopharyngeal, nasal, and oropharyngeal swab specimens, as well as nasopharyngeal wash/aspirate or nasal aspirate specimens. Unlike wet assays, which must be stored frozen and require pipetting of multiple reagents by an experienced biologist, Biomeme’s SARS-CoV-2 test is lyophilized (freeze-dried) to not only maximize shelf-life but to also enable easier transportation and storage without a cold chain.

Each test is a ready-to-use formulation that largely simplifies assay setup because each reaction well already contains the necessary master mix, enzymes, and multiplexed primers and probes. The test also includes Biomeme’s RNA Process Control (RPC) for RNA extraction and RT-PCR to identify potential inhibition in RNA samples, differences in sample handling, or an issue with the reagents.

The test utilizes Biomeme’s DNA/RNA Preservation Buffer for sample collection, M1 Sample Prep Cartridge for RNA extraction, and Biomeme’s portable Franklin™ Real-Time qPCR Thermocycler using it’s 3-well Go-Strips. Franklin’s companion mobile app, Biomeme Go, is used to run the tests and display test results in real-time for fast, simple interpretation. The test can also be used with the BD swab collection kit with VTM and can be run using Biomeme’s 96-well Go-Plates on lab-bound PCR systems such as Bio-Rad’s CFX96 or Applied Biosystems Quant Studio 5. Whether using Biomeme’s portable thermocycler to run up to 9 samples simultaneously or a lab thermocycler like the CFX96 or ABI QS5 to run up to 96 reactions, you can expect test results in as little as 1 hour.

Biomeme’s test was approved for emergency use by Health Canada in June and is currently in a number of satellite labs and low-resource settings, including an Ontario mining company, New Gold Inc. New Gold CEO Renaud Adams has been dedicated to establishing a COVID-free workplace and quickly adopted Biomeme’s test. “It’s a new technology,” Adam’s said to CBC News. "We're prepared, you know, to have a period of adjustment if need be. But at the end of the day, it could only be positive."

Key Differences Between Biomeme’s Test Kits and Others

There are considerable advantages to using Biomeme’s SARS-CoV-2 test in comparison to others:

Efficient - A multiplexed reaction means that all targets are in a single reaction. So, a single reaction equates to a single sample.

RNA Process Control (RPC) - As mentioned earlier, Biomeme’s test kits include a quantified exogenous positive control. It is a shelf-stable, lyophilized pellet of MS2 bacteriophage that you can expect to be detected around the same Cq every time.

Concentrated - Because the Biomeme test is lyophilized, you are able to add more sample (“template”) to the test (20 µL), which will directly increase sensitivity without throwing off your reagent concentrations.

Shelf-Stable - Most assays require shipment on dry ice and storage in a -80°C freezer, increasing the risk of components going bad due to freeze and thaw cycles. With Biomeme’s test assay, there is no need for refrigeration, lab equipment, or mixing of wet reagents. Just add your purified RNA and get testing.

Pre-Mixed & Pre-Aliquoted - Most assays come as multiple, separate components in bulk and need to be mixed and aliquoted by an experienced molecular biologist, further increasing the risk of contamination. There is no mixing or aliquoting of components required with Biomeme’s test. It’s already taken care of.

Biomeme co-founder and Biology Lead, Jesse vanWestrienen, took the lead on developing Biomeme’s test in February when SARS-CoV-2 was still primarily contained in Asia and eastern Europe. Jesse saw that the virus had the potential to affect the United States and quickly got to work developing a solution using Biomeme’s field-ready products and his years of expertise. Jesse says, “one of the main reasons my co-founders and I founded Biomeme was that we wanted real-time PCR to be very accessible.” Biomeme’s technology applied to SARS-CoV-2 gives healthcare providers the ability to rapidly detect the virus so that infected patients can be quarantined and treated to slow down the spread of COVID-19 no matter how remote the test site may be.

EUA Approved COVID-19 Test Form Factors by Use Case

Biomeme Go-Strips™ are pre-cut and pre-aliquoted trays of (32) 3-well Go-Strips. Each well contains a 20 µL lyophilized triplex reaction. This form factor is ideal for CLIA high complexity laboratories requiring overflow testing, as well as operating lower throughput testing in remote locations and temporary test sites. When used with the internally battery-powered Biomeme Franklin™ Real-Time qPCR Thermocycler, you can test up to 9 samples using three Biomeme Go-Strips™ within 60 minutes.

Biomeme Go-Plates™ are 96-well plates that contain a 20 µL lyophilized triplex reaction in each well. Go-Plates™ can be used on the Bio-Rad CFX96, the Applied Biosystems QuantStudio 5 thermocycler, or even cut into 3-well, 6-well, or 9-well strips for use in the Biomeme™ Franklin Real-Time PCR Thermocycler. Go-Plates™ are ideal for central labs and other test sites that require higher throughput testing.

Biomeme is currently working with CLIA high complexity labs that are in need of a medium-throughput alternative for overflow testing in their high-throughput labs or adding mobile testing capabilities to their satellite labs. For organizations without their own CLIA high complexity labs but that still want to offer testing, Biomeme asks that you contact their subsidiary CLIA high complexity lab, One Health Labs, to get started.

About Biomeme

Biomeme entered into molecular detection in 2012 when it created the first smartphone add-on capable of performing real-time PCR. Since its inception, Biomeme has used advanced biology and chemistry, world-class hardware and software engineering, to create elegant solutions to complex problems. Headquartered in Philadelphia, USA, Biomeme offers a full suite of end-to-end mobile molecular solutions that perform to the gold standard used by the world’s most advanced central labs yet require no lab equipment or specialized experience to use. To find out more about Biomeme, visit biomeme.com.

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Tom Cook
@BiomemeInc
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