Sherlock Biosciences is partnering with binx health to not only bring to market the first point-of-care CRISPR product but also take the first step toward a new paradigm in health and diagnostics.
On January 4, 2018, Boston was shut down by a blizzard, but Rahul Dhanda was on a mission. A few months prior, the veteran of the diagnostics industry had gotten a call from David Walt—Harvard professor and scientific founder of biotech heavyweight Illumina—about a potential startup company Walt was exploring with synthetic biology pioneers Feng Zhang and Jim Collins. Despite the weather, Dhanda, in his business jacket and snow pants, trudged through two feet of snow to pitch his vision for that company to its founders. The day ended with dinner and one takeaway: “Let’s do it.”
That company is Sherlock Biosciences, and just two years after that fateful January day, it received the first FDA Emergency Use Authorization for its CRISPR-based Covid-19 test, and was named a Technology Pioneer by the World Economic Forum.
Today, Sherlock announced that it has partnered with binx health to scale the rapid diagnostic test for point-of-care settings ranging from doctors’ offices to grocery stores. It represents not only the first point-of-care CRISPR product to come to market, but the first step toward a new paradigm in health and diagnostics.
Sherlock’s namesake diagnostics platform, Specific High-sensitivity Enzymatic Reporter unLOCKing, is a technique that uses CRISPR to identify highly specific genetic sequences. It’s the perfect tool for diagnosing Covid-19 by the presence of the novel coronavirus, which is discernible by its specific RNA sequence. The CRISPR system is adapted from the bacterial immune system and is best known for its ability to edit genes. Typically, CRISPR uses a piece of guide RNA as a “WANTED” poster to seek out a target gene of interest, which is then snipped by its enzymatic partner, the Cas9 “molecular scissors.”
The incredible precision of CRISPR has revolutionized gene editing. That same specificity also makes it a powerful tool for diagnostics, which is vital in fighting pandemics. While SHERLOCK™ does not utilize Cas9, it employs the same underlying principle of enzymatic molecular scissors. Guide RNA strands serve as scouts for a specific sequence of genetic material. When the guide meets the virus, the enzymatic scissors are activated and chop up a reporter-probe-quencher sequence, generating a fluorescent signal that shows the presence of the virus.
When run in the lab, Sherlock’s diagnostic process produces results in under an hour. The company’s new partnership with binx will scale the technology and bring the testing time down to as little as 20 minutes.
binx’s FDA-approved and point-of-care testing system, binx io, is an easy-to-use desktop-sized instrument that has already made waves in testing for sexually transmitted infections. With its single-use cartridge system and the SHERLOCK™ platform installed, a binx io unit can analyze nasal swab samples and report a “detected” or “not detected” result for the novel coronavirus in under 30 minutes.
“The speed and performance of binx io makes it incredibly competitive and best-in-class,” says Dhanda. “The decrease in time and increase in performance of SHERLOCK™ in conjunction with binx’s platform creates an incredibly powerful way to manage the pandemic.” By providing diagnostic screening in everyday locations, binx and Sherlock are meeting a need for Covid-19 testing that remains highly urgent months into this pandemic, especially as case counts continue to rise in the United States.
Pivoting to conquer a pandemic
The team at Sherlock recognized early this year that the health crisis unfolding in China would soon become a global threat. Within a matter of days, the Board of Directors made a unanimous and resounding decision to alter course to combat Covid-19. Sherlock’s scientists responded with an inspiring demonstration of commitment, adaptability, and creativity. This quick turnaround to mitigate such a pressing problem speaks to the vast potential of Sherlock as a company.
“Never in my career have I worked at a company able to pivot so quickly in the way we have with this technology to work on Covid-19,” remarked Dhanda. “Everyone here is smart enough to do something else, but they’re here because they want to be scientists making an impact and they believe in making a difference in healthcare. I was impressed with how we went from vision to implementation almost overnight, and how quickly that happened really speaks to the culture of the company.”
“In commercializing the world’s first FDA-authorized CRISPR product, we are learning about the value of rapid, rigorous execution for realizing the translational potential of engineering biology,” adds Dr. Jim Collins. “Our team at Sherlock Biosciences was remarkable in their demonstrated ability to go beyond ideas, concepts and academic papers, to a developed, authorized Covid-19 diagnostic test that is supported by extensive data and strong corporate partnerships.”
The logistics side of the equation—supply chain, distribution, partners, regulatory compliance, and more—also seemed to fall into place in response to the Sherlock team’s sheer drive and resilience. These were potential hurdles that Dhanda, in a pre-pandemic world, had given himself two years to overcome, but the swift repurposing of research also catalyzed delivery to market. The result has been a profound ripple effect throughout the diagnostics space.
Reimagining diagnostics, screening populations
To date, America’s approach to Covid-19 testing has followed general trends in diagnostics. The scarcity of Covid-19 tests has forced healthcare providers to triage potential patients, prioritizing symptomatic individuals to confirm likely positive cases. While valuable and necessary, it is rare for these diagnostic results to make a difference in clinical care for patients, nor does such limited testing help researchers understand this deceptively complicated disease in a variety of populations.
The high-throughput testing facilitated by SHERLOCK™ and binx is “an incredible way to deliver results that were inconceivable even five years ago—we’re breaking the mold,” says Dhanda. “We tend to make decisions based on limited access to resources, and diagnostics have always been rationed. Covid-19 has just put a magnifying glass on that. But the unique restrictions placed on this industry start to fall away when we have new ways of getting results.”
For Dhanda and Sherlock, the answer—for Covid-19 and beyond—is moving away from reactive triage testing and towards broad-based screening, which allows researchers to better understand how a disease behaves in people and spreads throughout a population. Sherlock is uniquely poised to continue facilitating this shift to broad-based screening. In addition to the CRISPR-based SHERLOCK™, the company’s other technological cornerstone is the cell-free synthetic biology platform INSPECTR™ (Internal Splint-Pairing Expression Cassette Translation Reaction). INSPECTR™ shows great promise in the at-home testing market, thanks to its low cost, room temperature, and modular implementation..
“[INSPECTR™ and SHERLOCK™] are highly programmable—we can direct these tools towards anything we’d like,” explains Dhanda.
An at-home Covid-19 test through INSPECTR™, while not yet a reality, is just one of many possibilities for the platform. INSPECTR’s single-base specificity and rapid results could allow for crucial differentiation between influenza variants, drastically reduce the spread of infectious disease, add value to oncology, and even revolutionize non-medical industries such as agriculture and industrial testing. Much remains to be seen, but one thing is for certain—with the diagnostics market on the cusp of a transformation, Sherlock Biosciences is the company to watch.- Forbes