Rokline to Produce High-throughput Kits for Distribution Across the United States
BOSTON, May 11, 2021 – The 221b Foundation, a nonprofit organization established by Sherlock Biosciences to address the global COVID-19 pandemic while promoting diverse representation in STEM, today announced that it has granted a license to Rokline Health Concepts, LLC to develop and manufacture COVID-19 diagnostic tests using Sherlock’s CRISPR technology. The agreement will increase access across the United States, providing testing capacity for thousands of results per day.
By providing its CRISPR technology, called SHERLOCK, through The 221b Foundation, Sherlock is facilitating pathways for the development and delivery of rapid, accurate and automatable solutions to directly benefit patients and the fight against the global COVID-19 pandemic.
“With the most comprehensive IP estate in CRISPR diagnostics, we believe that providing open access to it for COVID testing will expedite the end of the pandemic,” said Rahul Dhanda, co-founder, president and CEO of Sherlock Biosciences and founding board member of The 221b Foundation. “The team at Rokline has a long history of clinical excellence in bringing tests to market, and we look forward to working with them as they validate our high-throughput option, a critical need to increase testing capacity in response to the pandemic.”
The SHERLOCK diagnostic platform can achieve single molecule detection of nucleic acid targets; its name stands for Specific High Sensitivity Enzymatic Reporter unLOCKing. SHERLOCK utilizes CRISPR activity for “smart amplicon detection” and can be adapted for use with existing diagnostic instruments, improving time to result due to its significant multiplexing capacity. When a specific sequence of DNA or RNA is present, a CRISPR enzyme is activated and, much like a pair of scissors, starts cutting nearby genetic material, releasing a fluorescent signal that indicates a positive result. In May 2020, Sherlock 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.
Rokline Health Concepts was founded to identify and apply innovative technologies to health care diagnostics for the early detection of disease. Diagnostic products will be commercialized in its network of CLIA certified laboratories, and manufactured for worldwide distribution.
“I am honored that I can leverage my many years of clinical laboratory experience to bring Sherlock’s CRISPR platform to the market during a time of such global need,” said Herbert A. Fritsche, Ph.D., co-founder of Rokline Health Concepts. “The ability of the assay to be automated for high-throughput is incredibly valuable, and we look forward to demonstrating that this novel CRISPR-based test is uniquely suited to managing patients through the pandemic.”
About The 221b Foundation
The 221b Foundation was founded with the dual mission to assist in the eradication of COVID-19, while supporting racial and gender diversity in STEM. By providing support and intellectual property that enables both non-profit and for-profit entities to develop CRISPR-based diagnostic testing, The 221b Foundation seeks to aid in the fight against the global COVID-19 pandemic while furthering access and diversity in STEM industries. Led by industry experts in the fields of diagnostic testing, STEM and diversity, The 221b Foundation envisions a world where advances in CRISPR technology fuel the innovations that will put an end to the COVID-19 pandemic. For more information, please visit: 221bfoundation.org.
About Sherlock Biosciences
Sherlock Biosciences is dedicated to providing global access to the simplest and most accurate tests that empower individuals to control their own healthcare. Through its Engineering Biology platforms, the company is developing applications of SHERLOCK™, a CRISPR-based method for “smart amplicon detection,” 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 2020, the company made history with the first FDA-authorized use of CRISPR technology. For more information visit Sherlock.bio.
Katie Engleman, 1AB