The kit, for which Sherlock Biosciences recently received Emergency Use Authorization by the US Food and Drug Administration, will be used to test clinical samples from patients from D-HH member hospitals.
The Sherlock CRISPR SARS-CoV-2 test kit is designed for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 USC. §263a, to perform high complexity tests.
Based on the SHERLOCK method, which stands for Specific High-sensitivity Enzymatic Reporter unLOCKing, 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 specimen.
When the signature is found, the CRISPR enzyme is activated and cuts reporter RNAs provided as part of the kit to release a detectable signal, yielding results in about an hour.
It is the first and only CRISPR-based diagnostic test to receive EUA from the FDA for qualitative detection of nucleic acid from SARS-CoV-2.
Dartmouth-Hitchcock Health is New Hampshire's only academic health system and the state's largest private employer. It serves a population of 1.9m across Northern New England.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial