New test being submitted for Emergency Use Authorization (EUA) is designed to detect SARS-CoV-2, influenza A, and influenza B from a single patient sample
CORALVILLE, Iowa (January 19, 2021)
– Integrated DNA Technologies (IDT)
, a leading comprehensive genomics solutions provider, is developing a multiplex RT-qPCR test that can detect and distinguish between SARS-CoV-2, influenza A, and influenza B from a single patient sample. The new PrimeTime™ SARS-CoV-2/Flu Test is being submitted by IDT for U.S. Food and Drug Administration Emergency Use Authorization (EUA).
The new broad usage test is the first in vitro diagnostic product being developed by IDT, which has long been an industry leader in the manufacture of high-quality custom nucleic acids and serves over 130,000 life sciences researchers in more than 100 countries. The PrimeTime SARS-CoV-2/Flu Test combines a number of IDT’s components into a single test solution, which will be especially helpful for laboratories that are experiencing supply chain challenges for testing reagents. The IDT test will be able to be utilized as an “open system solution” validated on several different instrument platforms, enabling more widespread use.
“IDT is uniquely positioned to create a single testing solution for customers who have faced challenges securing reagents for both SARS-CoV-2 and influenza testing,” said IDT President Trey Martin. “IDT’s high-quality, reliable products have played a key role in virus detection and research during the pandemic, and the PrimeTime SARS-CoV-2/Flu Test provides a highly scalable, precise, and cost-effective solution.”
The PrimeTime SARS-CoV-2/Flu Test will include primers, probes, master mix, dilution buffer, and controls—manufactured with the highest standards of quality—packaged into a test kit for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. These novel RT-qPCR reagents from IDT will enable CLIA labs to help meet or expand their testing capacity.
The PrimeTime SARS-CoV-2/Flu Test will be the latest IDT achievement in response to the global pandemic. IDT was the first company in the nation to have its primer and probe kits approved by the Centers for Disease Control and Prevention (CDC) for use as a key component of the CDC EUA testing protocol for the diagnosis and detection of COVID-19. As of January 8, 2021, IDT has produced primer and probe kits sufficient to enable approximately 62 million tests to be conducted in the United States pursuant to the CDC EUA testing protocol.
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Integrated DNA Technologies, Inc. (IDT)
develops, manufactures, and markets nucleic acid products for the life sciences industry in the areas of academic and commercial research, agriculture, medical diagnostics, and pharmaceutical development. IDT has developed proprietary technologies for genomics applications such as next generation sequencing, CRISPR genome editing, synthetic biology, digital PCR, and RNA interference. Through its GMP services, IDT manufactures products used by scientists in researching many forms of cancer and most inherited and infectious diseases. IDT is widely recognized as the industry leader in custom nucleic acid manufacture, serving over 130,000 life sciences researchers. IDT was founded in 1987 and has its manufacturing headquarters in Coralville, Iowa, USA, with additional manufacturing sites in San Diego, California, USA; Research Triangle Park, North Carolina, USA; Leuven, Belgium; and Singapore. For more information, please visit www.idtdna.com
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