As new COVID-19 variants are rapidly spreading around the globe, diagnostic providers have had to prove that their tests can accurately identify new virus strains as they emerge
MatMaCorp's COVID-19 2SF RNA test effective in detecting variants. (Credit: dianakuehn30010 from Pixabay)
MatMaCorp (Materials and Machines Corporation), a developer of comprehensive molecular diagnostic systems, today announced data demonstrating the effectiveness of the company’s COVID-19 2SF RNA test in detecting variants associated with SARS-CoV-2, the virus causing COVID-19. Preliminary evaluation by MatMaCorp indicated that the company’s COVID-19 test is capable of detecting >99.5% of 3,801 coronavirus variants reported worldwide to date.
As new COVID-19 variants are rapidly spreading around the globe, diagnostic providers have had to prove that their tests can accurately identify new virus strains as they emerge. This evaluation by MatMaCorp follows guidance issued by the U.S. Food and Drug Administration (FDA) recommending test developers to consider the potential for future viral genetic mutations when designing new tests and also conduct routine monitoring to evaluate the potential impact of new mutations on current tests.
MatMaCorp has not had to modify its COVID-19 2SF RNA test to ensure effectiveness against variants, because the test was developed specifically to identify a highly conserved gene within SARS-CoV-2. To identify the virus, MatMaCorp’s COVID-19 test employs ‘padlock probes’ – small bits of DNA targeted with high specificity toward the RNA-dependent RNA polymerase (RdRp) gene, an essential gene for viral replication. Notably, the RdRp gene has not accumulated significant changes in any of the COVID-19 strains so far identified and analyzed by MatMaCorp.
Dr. Abe Oommen, MatMaCorp founder and President, said, “Based on our experience working with other RNA viruses, we were able to build on our past successes and take a completely different approach when developing our COVID-19 test. Because the RdRp gene sequence we detect in our COVID-19 2SF RNA test is highly conserved in the virus, our test retains effectiveness in detecting all currently known variants of the coronavirus.”
“As of February 17th, all of the available information in global public databases show that the variations such as B.1.1.7, B.1.351, and P.1 do not show changes in the RdRp gene,” says Dr. Ted Kalbfleisch, bioinformatician and founder of Invictus Informatics.
Bioinformatics analysis provided by Dr. Kalbfleisch showed that MatMaCorp’s 2SF RNA test can detect 99.7% of isolates for B.1.1.7 (UK variant), 99.8% of isolates for B.1.1.28 (Brazil variant), 100% of isolates for B.1.351 (South Africa variant), and 100% of isolates for B.1.525 (emerging global variant).
MatmaCorp’s test, performed on the company’s Solas 8® portable detection system, was recently granted an EUA by the U.S. FDA. It is classified as a high complexity test; the portable testing platform can rapidly perform multiple RT-PCR assays and has been validated by six independent locations across the country. It currently supports testing in rural community hospitals, and the company is working on additional claims to expand the use of the platform.
In addition to the Solas 8 platform, the company is also diligently moving forward with the development of a hand-held real-time PCR device that is capable of detecting and quantitating DNA or RNA targets within one hour and providing cycle threshold (Ct) values.
This new system is geared towards the global point-of-care (POC) market and is expected to be available later in 2021 for wider use in molecular diagnostic applications.
Source: Company Press Release