Scout Health Accelerates Point-of-Care STI Test Development With $6M CARB-X Award

Original from: genomeweb

Scout Health announced Wednesday that it has been awarded up to $6 million in funding support from the antimicrobial resistance nonprofit CARB-X. The firm plans to use the funding to finalize development of a next-generation version of its rapid point-of-care system and assay for chlamydia and gonorrhea and hopes to soon begin pilot studies in low- and middle-income countries (LMICs).

Alex Jiao, cofounder and CEO of Santa Clara, California-based Scout, said in an interview that Scout was granted the expansion of a $1 million CARB-X award granted last year after achieving a cost of goods that is orders of magnitude lower than other solutions for its loop-mediated isothermal amplification system.

Experts concur that a low-cost, highly sensitive and specific test for common STIs like Neisseria gonorrhoeae and Chlamydia trachomatis would be a game changer, both for patients who experience shame about visiting a clinician in person and for the rising rates of antimicrobial resistance related in part to empiric prescribing for STIs. The latter practice is common and particularly prevalent in low-and middle-income countries.

"Rapid point-of-care molecular testing for chlamydia and gonorrhea closes one of the largest gaps in STI care — the time between testing and treatment," said Sharon Moise, chief medical officer at Medcor and a clinical adviser to Scout Health.

Delays in effective treatment allow infections to persist and spread, and for women in particular, this can drive complications like pelvic inflammatory disease and infertility, Moise said.

Scout's second-generation instrument was redesigned with input from the National Institutes of Health Rapid Acceleration of Diagnostics (RADx) team for easy, scalable manufacturing and assembly.

"Over time, if more of this product is adopted, it's not challenging for us to meet the demand," Jiao said, adding that this might be critical if the test is successful in LMICs. Scout is aiming for a single-digit cost of goods for its US-manufactured and -supplied test cartridges, with a cost of less than $100 for the reusable test hub.

The next-gen test hub includes a third detection channel, enabling expanded multi-target detection, Jiao said. Scout is also working on ways to expand the multiplexing over time, potentially enabling the firm to add resistance markers to its testing.

Demand in LMICs is a bit unclear because the actual rate of CT/NG infections is "a huge blind spot," Jiao noted. That said, CT/NG rates in some high-income countries are also somewhat murky, and Jiao noted that even developed countries have a low reimbursement rate for molecular STI testing. And, the US is "probably one of the most tested countries for STIs, and still under-tested," he also said.

Moise believes that by delivering test results during the initial patient visit, POC MDx can dramatically improve care adherence, reduce transmission, and lower downstream clinical and economic burdens.

"In resource-constrained settings, both rural US and globally, this model is transformative because it bypasses logistical hurdles that have historically undermined public health efforts," she said.

Among developers of rapid POC molecular diagnostic systems, a sizable proportion have not survived the post-COVID bust. For those that have - firms like Visby, Scout Health, Aptitude Medical, or OraSure's Sherlock Biosciences - the pivot to non-respiratory applications has almost exclusively led to sexually transmitted infection testing and CT/NG specifically.

Visby's 30-minute, disposable, over-the counter PCR test for CT/NG as well as trichomonas broke the space open when it obtained premarket authorization and CLIA waiver in March of this year. A version of that test was authorized for clinical use in 2021, while the at-home test was granted de novo authorization for use by women in March, then granted 510(k) for clinical use on samples from men in October. Visby also recently disclosed that it would be temporarily pausing the manufacture of the clinical version of its tests to focus exclusively on developing the OTC market opportunity.

Meanwhile, other companies are launching CLIA-waived near-patient CT/NG assays for clinical use. Roche debuted two tests for the Liat system in February, for example, while Becton Dickinson reportedly began clinical trials for its BD Elience point-of-care MDx system and 15-minute CT/NG assay last year. The Binx IO, the flagship near-patient MDx STI test system, is also still commercially available. In total, a database maintained by the nonprofit FIND indicates more than three dozen of the 196 POC molecular system developers globally may be working on STI assays.

Moise said Scout's system combines molecular accuracy with "real-world clinical usability," while other rapid testing approaches may sacrifice sensitivity, particularly for asymptomatic infections.

"Scout has managed to deliver a molecular platform that maintains lab-quality performance while being fast, simple, and deployable in urgent care, outpatient settings, rural clinic settings, campus clinics, and health department facilities," she said.

Clinical workflow integration is also critical, and Moise said Scout's test system excels here, as well. "Very few systems currently on the market check those boxes simultaneously," she added.

Meanwhile, providers lose countless patients to follow-up and want faster diagnostics without sacrificing molecular accuracy. Medcor operates more than 300 outpatient clinics in the US as well as a telehealth program and is continuously evaluating technologies to improve access, accelerate clinical decisions, and reduce health risks, Moise said.

"We have settings in which Scouts CT/NG test would be ideal and would enhance our care delivery and enable treatment compliance and better outcomes," she added.

The field will still require some educating, particularly around workflow and public health impact, Moise also said. Most health systems have designed their patient care workflows around lab turnaround times, but from her perspective, "when a provider sees what happens when a patient is diagnosed, treated, and counseled in a single visit, the shift is immediate.

Enabled by POC MDx tests like Scout's, the potential future transition "from episodic testing to encounter-based care, is where the real change will occur," Moise said.

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