Bioinformatics Analysis Determines the Detect Covid-19 Test is Programmed to Identify Mutating SARS-CoV-2, Providing Lab-Accurate Results in One Hour at Home
GUILFORD, Conn., November 30, 2021--(BUSINESS WIRE)--Detect™, Inc., a Connecticut-based health technology company, announced today that its PCR-quality, at-home rapid molecular Detect™ Covid-19 Test recognizes the Omicron (B.1.1.529) SARS CoV-2 variant. Detect’s comprehensive bioinformatics analysis indicates that the Detect Covid-19 Test will identify Omicron as accurately as it recognizes the other major Covid-19 variants. Of the 121 isolated Omicron Covid-19 viral genome sequences publicly identified by the GISAID database, none of them carry any mutations in the genome region targeted by the Detect Covid-19 Test.
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The Detect Covid-19 Test identifies Omicron as accurately as it recognizes other major Covid-19 variants and will be available for purchase via Detect.com starting in mid-December. Once available, it will be the lowest cost, PCR-quality test on the market among a new class of rapid molecular tests. (Photo: Business Wire)
The Detect Covid-19 Test takes the multi-step, complex lab test process and reduces it to an easy-to-use, affordable, over-the-counter at-home test with only three minutes of hands-on time to provide PCR-quality results in less than one hour. Detect’s molecular test amplifies small segments of viral RNA, which enables it to identify an infection at lower viral loads than antigen tests, allowing for earlier detection.
"In light of the newly identified Omicron variant, we conducted a comprehensive computational analysis and looked carefully at the available Omicron genomic sequences. Our analyses found no mutations in the region targeted by our test," states Eric Kauderer-Abrams, Chief Technology Officer for Detect, Inc.
The Detect Covid-19 Test was designed to accurately identify SARS-CoV-2 in spite of mutation by targeting a region of the viral genome that is less likely to develop persistent mutations. To further safeguard against potential new mutations and variants, Detect uses proprietary nucleic acid amplification technology that is more robust than laboratory PCR to random mutations appearing in the targeted genome region.
To guarantee this performance in the face of the mutating virus, Detect continuously scans public viral genome sequences for mutations with potential to interfere with virus identification, ensuring that the test accurately identifies new variants, including Omicron.
As a testament to the Detect Covid-19 Test’s performance and ability to meet national testing needs, the Detect Covid-19 Test was recently selected for the highly competitive National Institutes of Health (NIH) Rapid Acceleration of Diagnostics Initiative (RADxSM) for an $8.1 million contract to scale up manufacturing.
"Through the NIH RADx contract, Detect has access to the U.S. Variant Task Force (VTF). Together, we are constantly monitoring new variants for potential interactions with our test by computational surveillance," explains Harry Kemble, Detect’s Informatics and Nucleic Acids Group Lead. "In addition, via the VTF, Detect has access to wet lab testing to confirm strong test performance should any potentially problematic new variants arise in the future."
The Detect Covid-19 Test will be available for purchase via Detect.com starting in mid-December. Once available, it will be the lowest cost, PCR-quality test on the market among a new class of rapid molecular tests. One single-use test will cost $49 and the reusable Detect Hub will be sold separately at $39, giving individuals the speed, convenience and accuracy to safely attend school, return to work, gather and travel.
About Detect™, Inc.
Detect, Inc. (www.detect.com) is a health technology company with the mission to build tools that empower people to understand their health and make informed, timely decisions by bringing accurate testing into the home. Founded by world-renowned scientist, entrepreneur and National Medal of Technology and Innovation recipient, Dr. Jonathan Rothberg, Detect, Inc. has created an accurate, fast, and easy-to-use PCR-quality molecular Covid-19 test.
The technology also serves as a platform for future home tests, such as influenza and STIs. Detect, Inc. is part of 4Catalyzer, a health technology accelerator that strives to transform 21st century medicine by solving today’s most challenging problems across life science research tools, medical devices and therapeutics. To learn more, visit: detect.com and 4catalyzer.com.
The Detect Covid-19 Test has not been FDA cleared or approved but has been authorized by FDA under EUA. 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.
This project is supported by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative and has been funded in whole or in part with federal funds from NIBIB, NIH, Department of Health and Human Services, under Contract No. 75N92022C00002.
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