Data Shows 100% Concordance with Real Patient Samples; Study Supports CRISPR-based Test Diagnostic Accuracy to Detect COVID-19

September 01, 2020 08:30 AM Eastern Daylight Time

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sherlock Biosciences, an Engineering Biology company dedicated to making diagnostic testing better, faster and more affordable, today reported data from a 20 clinical sample pilot study conducted by Gregory J. Tsongalis, Ph.D., and his team at Dartmouth-Hitchcock Medical Center in Lebanon, NH. The study evaluated the accuracy and performance of the Sherlock™ CRISPR SARS-CoV-2 kit for the detection of nucleic acid from the novel coronavirus that causes COVID-19. Sherlock test results were 100 percent concordant with results from Dartmouth-Hitchcock’s lab-based polymerase chain reaction (PCR) test method.

“We have been encouraged by results from the pilot study of Sherlock’s CRISPR-based test,” said Wahab Khan, Ph.D., Assistant Director of the Laboratory for Clinical Genomics and Advanced Technology at Dartmouth-Hitchcock. “At a time when COVID-19 clinical diagnosis is in high demand – and often with limited resources – this approach highlights the value of mature, new technologies to provide valuable alternatives for the detection of not only COVID-19 but other emerging infectious diseases. We look forward to continuing our studies with CRISPR diagnostics with the goal of continually expanding our data set to characterize the value of this important molecular diagnostic approach.”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. The kit, for which Sherlock Biosciences recently received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA), is based on the SHERLOCK method, which stands for Specific High sensitivity Enzymatic Reporter unLOCKing. The Sherlock CRISPR collateral detection reaction identified SARS-CoV-2 across a range of viral loads with high accuracy in previously tested patient samples.“Results from this pilot study have demonstrated – in real patient samples – that our CRISPR-based diagnostic test accurately reports the presence or absence of the SARS-CoV-2 virus,” said William J. Blake, Chief Technology Officer at Sherlock Biosciences. “We are grateful for an independent assessment of our test by leading molecular diagnostic experts at Dartmouth-Hitchcock and look forward to announcing additional data from their ongoing study in the coming weeks.”About Sherlock BiosciencesSherlock Biosciences is dedicated to making molecular diagnostics better, faster and more affordable 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.About Dartmouth-Hitchcock HealthDARTMOUTH-HITCHCOCK HEALTH (D-HH), New Hampshire’s only academic health system and the state’s largest private employer, serves a population of 1.9 million across Northern New England. D-HH provides access to more than 2,400 providers in almost every area of medicine, delivering care at its flagship hospital, Dartmouth-Hitchcock Medical Center (DHMC) in Lebanon, NH. DHMC was named again in 2020 as the #1 hospital in New Hampshire by U.S. News & World Report, and recognized for high performance in 9 clinical specialties and procedures. Dartmouth-Hitchcock Health also includes the Norris Cotton Cancer Center, one of only 51 NCI-designated Comprehensive Cancer Centers in the nation; the Children's Hospital at Dartmouth-Hitchcock, the state’s only children’s hospital; affiliated member hospitals in Lebanon, Keene, and New London, NH, and Windsor, VT, and Visiting Nurse and Hospice for Vermont and New Hampshire; and 24 Dartmouth-Hitchcock clinics that provide ambulatory services across New Hampshire and Vermont. The D-H system trains nearly 400 residents and fellows annually, and performs world-class research, in partnership with the Geisel School of Medicine at Dartmouth and the White River Junction VA Medical Center in White River Junction, VT.

Contacts

Katie Engleman, 1ABkatie@1abmedia.comAudra Burns, Dartmouth-Hitchcock Healthaudra.m.burns@hitchcock.org

Source: https://www.businesswire.com/news/home/20200901005358/en/Sherlock-Biosciences-Announces-Clinical-Data-Dartmouth-Hitchcock-Health%E2%80%99s