This story has been edited to more accurately describe the potential support from the RADx Tech program.
NEW YORK – Los Angeles-based startup Sensible Diagnostics says it has developed a small, low-cost, sample-to-answer instrument that can perform PCR in 10 minutes. The firm expects to launch its system in early 2024 along with low-cost test cartridges, initially focusing on infectious disease testing at the point of care.
A recent spinoff from Curative, Sensible is currently vying for support from the National Institutes of Health RADx Tech program.
Sensible would pursue US Food and Drug Administration clearance for a multiplex respiratory viral panel for use in CLIA-waived settings, according to Earnest Templin, CEO at the firm.
Mark Kelleher, a former director of laboratory operations at 23andMe, serves as Sensible's chief operating officer. Kelleher, Templin, and a number of current Sensible employees had previously been part of the team at Curative developing and coordinating COVID-19 testing during the pandemic.
While Curative initially partnered with KorvaLabs in April 2020 to offer lab-based COVID-19 testing from a central lab in San Dimas, California, it eventually branched out to about 10,000 pop-up sites in Los Angeles and across the country that used commercial point-of-care test systems.
"We tried all the other platforms on the market," Templin said. "We were not happy with those platforms for a variety of different reasons — cost, of course, being a huge one, but speed, sensitivity, workflow — all of these platforms had various problems," he added.
The team also got to know laboratorians' pain points as they performed an epic amount of testing. "A lot of scientists and engineers have never seen someone run a point-of-care test, so it was really important for us to get out there and see how these things actually run," Templin said.
Point-of-care testing can actually improve patient safety and economic outcomes for the health systems that are performing it, Templin said, but, in observing what was going on at testing sites, he and his team gathered that point-of-care venues desperately needed faster, lower-cost PCR systems. This led them to design a test system from the ground up over the course of about two years while they were still part of Curative.
Kelleher noted that Sensible's system is straightforward and simple to use, with assay design taking only a few weeks because it uses "well-understood technology."
The team allowed the molecular biology to inform the engineering, and vice versa, Templin said, focusing on making the system affordable, scalable, fast, and easily manufactured, in part by incorporating fewer parts and processing steps. The system overall takes advantage of many of the hardware, enzyme, and PCR reagent advances that have happened over the past 15 years, Templin also said, to couple proprietary thermal cycling technology and cartridge design with a direct-to-PCR format.
The firm has manufactured 80 units of the system so far through its validated production lines and is starting conversations with academic institutions and other early adopters. Although the systems were not used to deliver any patient results, operators at the Curative test sites also did some beta testing and helped to dictate the workflow design of the system, Templin said.
"Those are the people running it — those are the people who need to know it, understand it, and love it," he said.
The team is also planning a redesign of the system. Having purchased parts, such as microprocessors at "COVID prices," the current system would cost in the range of $5,000, but Templin said the team thinks this can come down to $3,500 with the redesign and current pricing for parts.
The test prices will be in the $10 to $20 range, and Kelleher noted that this includes the test cartridge as well as all sample collection components.
The initial target customers for Sensible will be urgent care centers, retail pharmacies, and primary care clinics, but the firm also hopes to address testing in hospital systems in the future.
"We intend to really be anywhere where infectious disease testing is being done," Templin said.
For its first test, Sensible will be pursuing FDA clearance of an oral swab-based group A strep test for use in CLIA-waived settings. Going forward, the firm plans to develop and market a suite of 510(k)-cleared infectious disease assays for respiratory and sexually transmitted infections as well as potentially DNA testing and assays needed in the neonatal testing space, Templin said.
Curative had some issues with the FDA during the pandemic related to its lab-based testing and use of oral swab samples instead of more standard nasal or nasopharyngeal swabs. While this was unrelated to the point-of-care system development, the experience did inspire Sensible to build a strong regulatory team, Templin said.
"We're very focused on ensuring that our devices are safe and effective and that the FDA will be completely happy and excited about what we're doing," he said.
Kelleher also noted that the company is fairly small, with about 14 people, but a quarter of them are working in regulatory issues. "If you are trying to change the way people do things, you have to be very strong on the regulatory and quality side, to make sure it is done correctly," he said.
The team was previously part of a RADx deep dive Tech III, and is also pursuing funding from NIH's Small Business Innovation Research program, the Biomedical Advanced Research and Development Authority (BARDA), and nongovernmental agencies. It was also accepted to pitch in the Chemical, Biological, Radiological, and Nuclear (CBRN) Defense Modernization Challenge at the TechConnect conference in Maryland in June.
Sensible is looking to close a Series A investment round for $9 million by the third quarter of this year and is currently in conversations with potential strategic, venture capital, private equity, and angel investors for this round, Templin said. The firm plans to use the funds to scale commercial operations, reduce test consumable costs, and clear additional infectious disease assays through the FDA.
"We are pursuing that with a lot of effort because it is not easy to get funding these days," Kelleher noted. "We have something that works and is not high risk, so we think this is a good funding opportunity," he added.
And although the team is small, the firm thinks it is differentiated from other startups by the fact that its technology is mature.
"I like to say, we're a startup, but we're not a startup," Templin said.