According to the Centers for Disease Control and Prevention (CDC), there are currently over 6.2 million confirmed cases of COVID-19 in the United States, and that number continues to rise for the time being. From wearing masks to sheltering-in-place, social distancing, and incessant hand-washing, every American has the ability to help our nation ebb the continued spread of the novel coronavirus.

In addition to encouraging Americans to adopt strict sterilization habits and apply them to their daily routine, more aggressive and ambitious methods need to be implemented like increased COVID-19 testing and contact tracing to slow the spread. SARS-CoV-2 is the virus that causes the coronavirus disease. The National Institutes of Health (NIH) is attempting to provide widespread testing for SARS-CoV-2 as a way to slow the spread and prevent others from contracting COVID-19.

NIH Investing in CRISPR-Based Coronavirus Testing

In an effort to ramp up mass testing, the NIH has invested $248.7 million to launch the RADx initiative in April of 2020. RADx, short for Rapid Acceleration of Diagnostics, is an initiative designed to provide accurate and effective rapid COVID-19 testing that can be distributed nationwide. To further their efforts, the NIH is also making strides in regards to accessibility.

COVID 19 Racial Disparity Bar Graph Comparison

Minority and lower-income communities have been some of the hardest hit by the coronavirus. Without access to easy-to-use and affordable, or even free, COVID-19 testing, slowing the spread is made significantly more difficult. The RADx-UP (RADx Underserved Populations) program is designed to work within the RADx initiative to address the spread of the coronavirus specifically in vulnerable populations.

So how does the NIH, with help from both government agencies and privately funded companies, expect to accomplish these lofty goals? Let’s take a deeper dive into the ins and outs of rapid COVID-19 testing and the biotechnologies that are being employed to lift America out of this global health crisis.

CRISPR Biotech to Revolutionize Rapid COVID-19 Testing Market

The coronavirus pandemic has created an urgency for large-scale diagnostic testing that is scalable, affordable, and user-friendly. Also referred to as rapid point-of-care (POC) tests, the safe reopening of society depends on coronavirus testing that can be taken at home or in a low-resource setting with quick turnaround times.

In recent months, The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to deploy POC tests that look for the presence of SARS-CoV-2. While most tests make use of polymerase chain reaction technology to magnify and identify the genetic materials present in the SARS-CoV-2 virus, it seems that one biotechnology offers the benefits of both accuracy and efficiency by using isothermal amplification methods instead. Here enters CRISPR.

CRISPRCRISPR, short for CRISPR-Cas9 and long for Clustered Regularly Interspaced Short Palindromic Repeats, is a very well-known biotechnological tool. Widely used for editing DNA sequences and gene therapy, CRISPR can also be used as a diagnostic tool for detecting the sequences in, you guessed it, the SARS-CoV-2 virus.

CRISPR has always been considered a gene-editing pioneer and some believe it could make COVID-19 testing as easy as a pregnancy test. This piqued the minds of the scientific community who were eager to find a solution for rapid POC testing.

With The U.S. Food and Drug Administration’s EUA in place for CRISPR-based Covid-19 point-of-care tests, the application of CRISPR biotechnology is now on pace to completely transform the coronavirus diagnostic testing market. Among the handful of biotech companies that were vying to lead this paradigm shift, Sherlock Biosciences wound up grabbing the brass ring.

Sherlock Biosciences, in a partnership with Binx Health, will become the first company to unveil an FDA-authorized CRISPR-based technology for COVID-19 diagnostic assays. Rahul Dhanda, CEO of Sherlock Biosciences, claims that the rapid POC COVID-19 tests will be largely inexpensive, with results expected within an hour. Researchers close to the project estimate that the materials for each test could cost about $6. Dr. Feng Zhang, a researcher at the Broad Institute in Cambridge and one of the pioneers of CRISPR biotechnology, hinted to the inexpensive nature of CRISPR-based COVID-19 testing, stating, “We’re excited that this could be a solution that people won’t have to rely on a sophisticated and expensive laboratory to run.”

The excitement in the scientific community is palpable. James J. Collins, co-founder and board member of Sherlock Biosciences and Termeer Professor of Medical Engineering and Science at MIT said, “When our lab collaborated with Dr. Feng Zhang’s team to develop SHERLOCK, we believed that this CRISPR-based diagnostic method would have a significant impact on global health.” Adding that, “During what is a major healthcare crisis across the globe, we are heartened that the first FDA-authorized use of CRISPR will aid in the fight against this global COVID-19 pandemic.”

The Sherlock test works by capitalizing on CRISPR technology to create an effective molecular diagnostics test. Much like other COVID-19 tests, the Sherlock assay requires a respiratory specimen from the mouth, nose, or lungs to detect the viral RNA. The RNA is then converted into DNA using isothermal amplification to make the viral genome easier to replicate and identify.

This innovation in rapid COVID-19 testing certainly changes the conversation as far as accessibility on a national scale, but we may not begin to see these tests being widely available for several months. That being said, with an upcoming fall flu season looming, some expect to see a resurgence of COVID-19 cases across the United States which will undoubtedly increase the demand for handheld diagnostic kits. At that point, it becomes a distribution issue, which will have to get worked out when the time comes.

While the implementation and distribution of rapid at-home COVID-19 testing gets sorted out for the general public, businesses actually have options available to them now. There are a select few biotech companies that have developed comprehensive coronavirus testing on a corporate level. Basically, they offer large scale COVID-19 tests for small to large companies that are eager to open back up but are concerned for the safety of their staff. The turnaround time is typically 2-3 business days, which is a godsend for business owners who are committed to reopening safely and as soon as possible.