Large-scale Manufacturing of Rapid Diagnostic Test Kit and Reagents to Enable Increased Testing Capacity for COVID-19 Worldwide
First-ever FDA-authorized CRISPR-based Diagnostic to Launch This Month
CAMBRIDGE, Mass. and CORALVILLE, Iowa (June 8, 2020)
– Sherlock Biosciences and Integrated DNA Technologies (IDT) today announced the companies have entered into a strategic collaboration to enable large-scale manufacturing of the Sherlock™ CRISPR SARS-CoV-2 kit for the detection of the novel coronavirus that causes COVID-19. The test kit, for which Sherlock Biosciences recently received
Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA), will assist in managing the COVID-19 pandemic by increasing testing capacity and decreasing time to result.
The Sherlock kit is the first CRISPR-based diagnostic test to receive EUA for the detection of SARS-CoV-2. The kit provides specific and sensitive detection of the virus in patient samples, and it requires no specialized instruments to complete a test. Using standard laboratory equipment gives it a minimal footprint and contributes to a turnaround time of approximately one hour, significantly faster than other testing methods.
IDT is supporting the manufacturing of the kit by supplying several key components, including the Cas13a enzyme on which the test is based, as well as CRISPR RNA (crRNA) and primer mix. IDT’s product quality, speed, and ability to scale are key factors in helping to bring the Sherlock kit to market.
“Given the severity and scale of the COVID-19 pandemic, it is imperative to increase and improve upon existing diagnostic solutions,” said Rahul Dhanda, co-founder, president and CEO of Sherlock Biosciences. “We are pleased to partner with IDT, a leading comprehensive genomics solution provider. They have already been leading the charge in large-scale manufacturing of key components for the CDC EUA testing protocol to meet the demands of this global pandemic, and this is another avenue in which they are supporting testing needs. Through this strategic partnership, we will be able to scale production as needed to satisfy the demand for increased testing volumes, which should allow laboratory technicians to run tests at a higher throughput and provide results rapidly to improve patient care.”
“Sherlock has developed a unique methodology for quick and specific detection of SARS-CoV-2, and IDT is proud to leverage our high-quality products to support this groundbreaking testing method,” said Trey Martin, president of IDT. “We look forward to working closely with Sherlock to scale the production of its CRISPR test kit to meet demand in response to this global pandemic.”
The Sherlock™ CRISPR SARS-CoV-2 test kit is designed for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests. Based on the SHERLOCK method, which stands for S
ing, the kit works by programming a CRISPR nuclease to detect the presence of a specific genetic signature – in this case, the genetic signature for SARS-CoV-2 – in a nasal swab, nasopharyngeal swab, oropharyngeal swab or bronchoalveolar lavage (BAL) specimen. When the signature is found, the CRISPR enzyme is activated and cuts both the target viral RNA and the reporter RNAs provided as part of the kit and used during the detection reaction. This releases a detectable signal, yielding results in about an hour. It is the first CRISPR-based diagnostic test to receive EUA from the FDA for qualitative detection of nucleic acid from SARS-CoV-2.
IDT will provide access to the CRISPR SARS-CoV2 kit via its website and ordering channels. Those interested in ordering the kit can do so here
About Sherlock Biosciences
is dedicated to bringing molecular diagnostics anywhere and everywhere through Engineering Biology platforms. The company is developing applications of SHERLOCK™, a CRISPR-based method to detect and quantify specific genetic sequences, and INSPECTR™, a Synthetic Biology-based molecular diagnostics platform that is instrument free. SHERLOCK and INSPECTR can be used in virtually any setting without complex instrumentation, opening up a wide range of potential applications in areas including precision oncology, infection identification, food safety, at-home tests, and disease detection in the field. In May 2020, the company received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Sherlock™ CRISPR SARS-CoV-2 kit, the first FDA-authorized use of CRISPR technology. For more information visit Sherlock.bio and follow us on Twitter at @sherlock_bio.
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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 Research Triangle Park, North Carolina, USA; San Diego, California, USA; Leuven, Belgium; and Singapore.
More information about IDT’s efforts to fight against COVID-19 can be found here
IDT is an operating company within Danaher Corporation’s (NYSE: DHR) Life Sciences platform. For more information, please visit www.idtdna.com
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IDT Public Relations
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