NEW YORK – To help diagnostics developers close expensive skills gaps, the National Institutes of Health is helping to create a smoother path to bring infectious disease tests and testing instruments to market by funding portions of the development work through a pool of contractors through a program called the Diagnostics Development Services program.
Point-of-care testing firm Fluxergy recently announced that it was the first company to participate in the DDS program through NIH's National Institute of Allergy and Infectious Diseases. The program will help the Irvine, California-based firm to expand its molecular testing capabilities and commercialize low-cost tests for sexually transmitted infections and vaginosis.
The DDS program officially launched in August 2023 but has been slow to gather momentum while NIH gathered in-house expertise to support it, an NIAID official said. However, NIAID officials have been spreading word about the service at conferences, and several more companies have recently applied for participation.
Under the agreement with Fluxergy, NIH-funded contractors will study the use of rapid nucleic acid extraction and purification methods for test cartridges that are used in that firm's test analyzer and help the firm to develop high-sensitivity sample-to-answer molecular tests for Gram-negative bacteria and fungal pathogens.
"This agreement with NIAID will allow us to accelerate progress toward commercialization of a full menu of easy-to-use, cost-effective, and lab-quality tests of the Fluxergy platform to address significant accessibility and affordability issues with point-of-care diagnostics available today," Fluxergy CEO Tej Patel said in a statement.
An official at NIAID said that the service is intended to aid test and instrument developers that have most of the capabilities that are needed to bring their tools to market but are missing key components for regulatory clearance and commercialization. Those participants may lack clinical scientists, regulatory experts, manufacturing expertise, or design control employees, among other components, and filling those gaps would otherwise require sizable investments.
Through the DDS program, NIAID maintains a stable of contract research organizations that can bid on development services from late-stage feasibility testing through clinical validation, and the agency pays for those services at no cost to the diagnostics developers. NIAID has signed seven-year indefinite delivery, indefinite quantity contracts to establish the pool of CROs, and it uses competitive bids to select the contractors that are best suited for the work.
While the agreements signed through the program do not come with an established funding ceiling for each participant, the NIAID official noted that the program is intended to support only portions of the development process. In the agreement with Fluxergy, for example, NIAID has agreed to pay for contract services over four months to provide sample preparation and PCR-based testing services to support the development of an STI test.
Patel said in an interview that the NIAID contract will help his firm to expand its product pipeline and offer more assays that are designed for use with the firm's cartridge-based multimodal testing platform, which it has been developing since 2012. As the company continues commercializing its technology in the US, Patel said that Fluxergy is focused on helping to expand access to testing in low-resource areas such as rural urgent care centers, particularly federally qualified health centers (FQHC). The company also plans to use its testing platform to offer POC testing in low- and middle-income countries.
"We really want to be able to do our part to reduce healthcare costs," he said.
Fluxergy has set a target price of under $3 for its basic metabolic panel, and Patel thinks that the company will be able to manufacture its molecular test cartridges for less than $2 each. Meanwhile, the company has already been selling its Fluxergy Analyzer in the veterinary market for $5,000.
He said that gonorrhea, chlamydia, and vaginosis are common causes of visits to urgent care centers, and the company is developing its test menu to identify targets that would be most useful for clinicians in those settings. The collaboration with NIAID contractors will help the firm to advance those tests for use with urine and vaginal swab samples.
Patel said that the NIAID program is providing his company with expertise in working with those sample types and the material costs for the studies, and he noted that the program is also providing indirect support through time and opportunity costs.
Fluxergy's testing instrument is used with its single-use microfluidic cartridges that can incorporate molecular, immunohistochemistry, cytometry, or electrochemistry testing technologies, with results in 25 minutes for its molecular assays and 10 minutes for its chemistry-based metabolic panels. The PCR tests, for example, involve nucleic acid extraction and concentration steps that are performed on the test cartridge, and the results are analyzed through the test instrument.
Patel said that the NIAID's assistance arrives as the firm prepares to launch a clinical trial in early 2025 for a new version of its CE-IVD-marked syndromic PCR assay for COVID-19, flu A/B, and respiratory syncytial virus. The company also plans to begin clinical trials in 2025 for a basic metabolic panel and a complete blood count assay, and he said that the firm plans to submit all three tests and the testing instrument for US FDA 510(k) clearance and launch them in the US during late 2025 or early 2026.
The tests are designed for use with the company's Fluxergy Analyzer, which has so far been used for a PCR assay for the SARS-CoV-2 virus, the first-generation respiratory panel, and tests that are sold in the animal health market for the detection of infectious diseases in horses.
The company also announced in January that it was collaborating on the development of sepsis tests in partnership with the Austere Environments Consortium for Enhanced Sepsis Outcomes, which is administered by the Henry M. Jackson Foundation for the Advancement of Military Medicine.
The firm also acquired last year employees, assets, and licensed decentralized blood testing technologies from Philadelphia-based blood testing startup InnaMed. Fluxergy said that the deal would allow the company to integrate into its testing platform InnaMed's decentralized electrochemical biosensor technologies and add the abilities to detect small molecules and clinical chemistries.
NIAID said on its website that the DDS program can be used to provide support for development processes and documentation, assay optimization aid, nucleic acid amplification and sequencing, immunoassay and lateral flow assay development support, and reagent development, production, and quality control. Startups, mature companies, universities, and NGOs may be eligible for participation if they are developing products to identify or characterize infectious pathogens that are considered to be high priorities for the agency.