Welcome to our first Startup Showcase on Molecular Ideas! Today, we explore how Rover Diagnostics is arming patients, practitioners, and public health officials with critical information by innovating on one of molecular science’s most fundamental tools – PCR.
Polymerase Chain Reaction, or PCR, is the backbone of modern molecular science. This technique is fundamental knowledge to researchers, clinicians, and diagnosticians for a multitude of purposes.
It’s no understatement to say that PCR’s accuracy is unparalleled, and its utility is nearly limitless. By exponentially copying or ‘amplifying’ precise sequences of DNA, you can detect the presence of a pathogen strain in a patient. You can augment bacteria to test antibiotic resistance. You can determine a person’s parentage and so much more.
However, application of this tool to point-of-care (‘POC’) diagnostics has been constrained by two key factors: time & technical expertise needed to leverage it. While patients and practitioners rely on the RT-PCR (Reverse Transcriptase PCR) test as the most accurate way to gauge one’s COVID-19 status, results often take days to emerge.
Why? Simple – the test is difficult to run at scale except by trained professionals using bulky equipment, and takes a minimum of 45 minutes. This means the test often takes place at an offsite lab, which translates to days before a patient receives their results.
Fortunately, Rover Diagnostics is providing much needed innovation to this time-honored tool. I sat down with the CEO, Mark Fasciano, to discuss his technology, vision, and role in making PCR an efficient, accessible point-of-care diagnostic tool.
Simply put, Rover is seeking to do in minutes what is typically done in hours – without sacrificing accuracy. Rover’s proprietary technology uses the tried-and-true mechanism of PCR providing two major upgrades in its execution. These upgrades are intended to bring it into the point-of-care environment without compromising efficacy.
The first improvement is a sample prep test kit containing key reagents, which meters the precise reaction volume without exposing the operator to the sample. This kit allows for greater scaling by removing the barrier of specialized training to the PCR process. As any researcher knows, pipetting single microliters of individual reagents is a painstaking task. Further, these kits are tailored to any one of several infectious diseases – including influenza, strep A, RSV, and the dreaded COVID-19.
Rover Diagnostics has chosen to focus applying their initial technology platform to each of these diseases because they meet three critical criteria:
1) Prevalence – these diseases are prevalent and frequently need to be diagnosed across demographics;
2) Accuracy – these diseases are well-defined in literature, and make it easy to ensure accuracy, and;
3) Urgency – determining a patient’s status early has massive cost savings and treatment implications.
The team realizes the promise of speedy, accurate testing by creating a more efficient way to heat cycles in the PCR process. The ‘copying’ or exponential amplification of key DNA is conducted by a series of enzymes that only work at specific temperatures. As such, heating and cooling the test tubes efficiently is critical to success. Traditional systems apply heat externally. This inefficiency creates exorbitant wait times; by contrast, Rover’s proprietary technology inverts this model, leading to a faster process.
This unique emphasis on speed is essential to Rover as they strive to apply their diagnostic platform to a point-of-care environment.
“That’s our mission – to give PCR results rapidly with no compromise on performance.” says Mark. Other COVID-19 ‘rapid tests’ are antigen tests. These are faster than traditional PCR-based tests, but at the cost of a notably higher error rate. This means that positive patients may appear negative, enabling the virus to spread.
Rover Diagnostics’ test closes the competitive gap to bring the best of both worlds. Their technology was spun out of Columbia University and developed under the expertise of Rover co-founder Sam Sia, a fellow serial entrepreneur and one of the US’ foremost expert on microfluidics. By leveraging their combined expertise, Mark and Sam have designed a system that also addresses one of the biggest challenges in point-of-care diagnostics: space. Diagnostic platforms are typically bulky, in addition to being inefficient and needing specialized training. Minimizing a shelf footprint expands the company’s opportunities for practitioner adoption.
I asked Mark about how COVID-19 has affected the company, and how the conversation around diagnostics is changing in the industry as a result:
“COVID-19 has shined a light on PCR tests for the general public. No one knew about how PCR runs other than scientists and clinicians – now everyone’s mom knows about it.”
That understanding enabled Rover Diagnostics to make progress by leaps and bounds over the last 10 months as part of the federal Rapid Acceleration of Diagnostics (RADx) program. Sponsored by the NIH as a way to accelerate efficient ways of diagnosing infectious disease, the company made “about two years of progress in six months.” Collaboration with leading experts in diagnostics enabled due diligence at an otherwise unthinkable pace for a startup company – and moving them almost as rapidly as their tests towards approval.
Of course, we also have to look ahead to the next potential pandemic. As a next-generation point-of-care diagnostic platform, accessing test results early will be essential to treating and containing disease. The challenge, as Mark pointed out, lies in the infrastructure used to distribute tests when a disease emerges.
“[Once a disease emerges,] we can’t wait another 18 months for the supply chain to get going. We’re going to need it available in a month or less after we identify a bad virus like this.”
So, what’s next? Rover Diagnostics is bringing accurate PCR testing to the point-of-care through an accessible, efficient platform without the burdensome limitations of traditional tests. Mark hopes to leverage his experience as a serial entrepreneur and Ph.D. from the University of Chicago in computer science to create an internet-of-things approach to securely sharing test results with patients, practitioners, and government contact tracers to close the timing gap between symptoms and treatment.
As I said, PCR is the backbone of modern molecular science. With the world watching for the next great innovation to help us manage COIVD-19, Rover Diagnostics makes us sit up and take notice by swiftly arming us with the greatest weapon against any disease – information.
That’s all for today! You can learn more about Rover Diagnostics here. Please share and sign up to leave your thoughts, ideas, and opinions in the comments.