My Pirola -- Staying vigilant with the variants
By Matt McFarlane, Research and Development Scientist
Why is the Anavasi Diagnostics platform a great solution for affordable and accurate point-of-care COVID-19 testing? Here is a scientist’s (not salesperson’s) take on it.
The AscencioDx® COVID-19 Test and Molecular Detector, by Anavasi, was designed from the start to ensure our assay would continue to detect the latest variants with target redundancy. Three distinct regions of the SARS-CoV-2 viral genome are detected by our assay which gives robust protection against any future mutations, since only one of the three regions needs to maintain performance for the test to successfully detect any variant.
Researchers around the world from public health, academia and private companies continue to sequence the covid virus and share them on databases such as GISAID/ROSALIND. Anavasi routinely checks the genomes of all SARS-CoV-2 sequences collected in the USA each month and compares the regions critical to performance and has maintained >99.9% ability to detect all variants observed in the USA.
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Anavasi also continually monitors reports of emerging variants which have potential for concern such as BA.2.86 (nicknamed Pirola) which was first sequenced August 13, 2023. Currently there are 5 genomes of BA.2.86 publicly shared and in silico analysis done by Anavasi confirms 100% coverage by our assay. Anavasi’s COVID-19 test will detect this variant if it spreads.
This variant is being watched extremely closely by experts around the world because it is as genetically different in Spike protein from the other current circulating variants as the first Omicron sequences were from the original SARS-CoV-2 virus. In fact, according to the CDC it has >30 amino acid differences compared with Omicron variant BA.2, which was the dominant strain in early 2022. It is still too early to tell what BA.2.86 will do. It could fade away, or it could cause a very large wave similar to when Omicron first emerged.
As Dr. Michael Blaivas discussed in our previous blog, it is imperative for healthcare providers to have access to testing methods that can provide accurate results quickly in order to make timely diagnostic decisions and treatments for their patients to ensure the best outcome.
In addition to these efforts, our team is committed to providing the very best in new products and has multiple Respiratory and Sexual Health assays in development, with clinical trials beginning for some as early as Q4 2023. Follow us on LinkedIn and stay informed and up to date on great things to come from Anavasi Diagnostics.
Additional Resources:
https://twitter.com/K_G_Andersen/status/1692222077707915651?s=20
https://twitter.com/firefoxx66/status/1692508068808970566?s=20
Where Speed, Efficiency, & Accuracy Align
The AscencioDx® Covid-19 Test and The AscencioDx® Molecular Detector have not been FDA cleared or approved, but have been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
