NEW YORK – While diagnostics startup Detect already has a COVID-19 test and instrument on the market — one of only three molecular at-home tests available in the US — the firm is working to develop a new system that could run multiple new tests.
The original system and SARS-CoV-2 test, which consists of a reusable hub and a single-use consumable, received Emergency Use Authorization from the US Food and Drug Administration in October for over-the-counter use. The pursual of OTC authorization represented a strategic change from the firm's original goal, which was for use of a test in broader point-of-care settings, Detect Chief Technology Officer and Cofounder Eric Kauderer-Abrams said.
The change came about as a result of the FDA clarifying the regulatory pathway to at-home authorization, Kauderer-Abrams said. Early in the pandemic, the road to OTC authorization wasn't totally clear, but in February of 2021 the company made the decision to refocus its efforts on home testing because it recognized that "the most impact that we could make at the time would be by releasing an over-the-counter home use test." To get there, it worked to simplify the testing process and optimize the test to reach higher specificity and sensitivity levels. One of the major innovations of Detect's product, Kauderer-Abrams said, is the ability to apply molecular amplification technology "directly on the raw sample," without further processing or extraction.
The company is still using its same loop-mediated isothermal amplification technology for the at-home test, but it put "a lot of work" into optimizing the test to make it lower cost and able to be manufactured at high volumes, he added. "One of our goals from the start was to be able to produce this at really large volumes for very inexpensive price points." Some of that work included adjusting the mechanical elements and product design of the instrument and simplifying the assembly processes.
For example, the firm previously bought lateral flow strips off the shelf and used those for the test's readout. To lower costs, the company designed its own lateral flow strips and contracted with a separate manufacturer directly so it could be in control of "every step of the process," Kauderer-Abrams said. "When we get down to that lower level of detail and control, we're able to really optimize costs."
Once the test and instrument had been improved, the firm began a clinical study in April and submitted its product to the FDA in August, Kauderer-Abrams said.
Currently, there are two other molecular at-home tests on the market in the US: Cue Health, which offers its reusable Cue Reader instrument for $249 and a three-pack of single-use COVID-19 tests for $195; and Lucira Health's Check It COVID-19 Test Kit, which costs $75 for a single-use kit. All told, Detect's offering comes out to less than both: Its reusable reader, which has an "infinite shelf life," is $39, and a single-use test is $49, with a combo pack of one test and the reader costing $85.
So far, the customer feedback has been positive, Detect Chief Strategy Officer and Cofounder Owen Kaye-Kauderer said, with anecdotal evidence that its test has been able to catch positive cases before rapid antigen tests. Although he declined to share sales figures, he noted that the firm is selling its product to corporations, enterprises, and other organizations, as well as directly to consumers.
In October, right before receiving its EUA, Detect received an $8.1 million milestone-based contract from the National Institutes of Health's Rapid Acceleration of Diagnostics initiative to scale up manufacturing, which Kaye-Kauderer said has helped Detect reach a manufacturing capacity of "hundreds of thousands" of tests per month.
Adding to that NIH grant, Detect is using a $22.9 million contract from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority to create a COVID-19/influenza multiplex test that will run on a next-generation instrument, which is currently in development. The new system will still use Detect's RT-LAMP technology but will have an even more simplified workflow with other "critical improvements," such as a reduced turnaround time and improved performance, Kauderer-Abrams said.
The company is looking to "close the price gap" between at-home antigen tests and its next-generation tests while maintaining its current performance, he said. Although he couldn't comment on the exact sale price, he said that the cost will be significantly reduced. "We want to release a test that maintains that molecular level performance but comes much closer to those antigen test price points."
The key differences between the original system and its new version are in the chemistry of the test and the hardware of the instrument, Kauderer-Abrams said. The company has been working on novel enzyme development and has created a new polymerase that has "faster kinetics" and better inhibitor tolerance that can help improve the test's sensitivity and turnaround time from one hour to between 10 and 30 minutes. Detect is also able to make the polymerase "very inexpensively at scale," he said.
That reaction mix has been combined with a new method of primer design, relying on an artificial intelligence-based platform that "produces high-performing, highly genetically inclusive primer sets," which can further boost the sensitivity and specificity, he said. The currently available COVID-19 test has a positive percent agreement of nearly 91 percent and a negative percent agreement of nearly 98 percent. The negative percent agreement figure was due to two users misinterpreting the results readout, but the company has improved the app to make results clearer to understand. The current test has been validated for most variants and the company has prepared for new variants, knowing that if a variant pops up that it can't detect, only the primers would need to be modified. "We have a playbook" for any new variants, Kauderer-Abrams said, and the company has had preliminary discussions with the FDA to discuss the potential for an accelerated validation process if minor changes need to be made.
The firm has also changed the way results are read out from the test in the new instrument, switching from the lateral flow strip to a direct readout from the hub by adapting the chemistry it uses. On the hub side, the company looked at what components of the hardware were most expensive and performed a trade-off analysis to determine what could be changed and where costs could be brought down. There was "no magic in it," Kauderer-Abrams said, just "the gritty work of going through and auditing what the big cost drivers of the system are."
For the multiplex COVID-19 and influenza test, Kauderer-Abrams said that the company is planning to run a clinical validation study during the upcoming respiratory season and then pursue EUA from the FDA. However, as the FDA has encouraged diagnostic test developers to begin moving from the EUA pathway to full 510(k) or de novo clearance, Detect has been developing the test "in such a way" that it will qualify for both forms of approval and will also seek 510(k) or de novo clearance, Kauderer-Abrams noted. The BARDA contract covers the firm through the receipt of FDA 510(k) clearance.
Thus far, the company has had a "laser focus" on FDA approval of its products, Kaye-Kauderer said, but it is evaluating other markets and regulatory approvals, including those from Health Canada and the European Union. "These are definitely in our plans for the future."
Beyond the combo COVID/flu test, the product roadmap is still under construction, Kauderer-Abrams said, although he did provide a glimpse into the company's future plans. There are tests for Streptococcus and sexually transmitted infections in the works, which would all run on the new instrument. Those three tests are the furthest along in development, but he added that "there's a whole longer tail of applications that we're developing and looking at."