NEW YORK – FIND announced on Monday that it is investing $21 million in four companies to develop and launch point-of-care molecular diagnostic platforms for infectious diseases.
The four companies are US-based Biomeme, Sweden-based Qlife, and South Korea-based Bioneer and SD Biosensor. They were selected from a pool of 47 firms responding to FIND's request during the summer for submissions of platforms to increase access to testing.
The investments are being funded by the German Federal Ministry of Education and Research through the Access to COVID-19 Tools Accelerator co-led by FIND, the nonprofit said.
The money will support the companies for a year to develop tests for the differential diagnosis of COVID-19 and other respiratory pathogens and to optimize their platforms to meet the needs of low- and middle-income countries, or LMICs, and the requirements for authorization under the World Health Organization's emergency use listing or prequalification process.
The funding will also support each company's manufacturing processes to "enable price reductions and increased volumes" and support regulatory submissions, FIND said. All of the companies are aiming to complete product development of their multi-respiratory pathogen tests by late 2022 for commercial launch in 2023.
Criteria for the funding included the technical performance of the platform, the added value to the diagnostics market, suitability for use in decentralized settings, and affordability for LMICs, FIND said.
The aims of the platforms are to diversify technology available in district hospitals and facilities across LMICs and "broaden access to testing in places that are close and convenient for patients," FIND said. All of the companies have agreed to "accessible pricing terms for LMICs," the organization added.
"These investments create a major opportunity for these new market entrants to serve LMICs while kick-starting a pipeline of critical point-of-care molecular diagnostics," Marta Fernández Suárez, FIND's chief technology officer, said in a statement. "Given the multi-pathogen capabilities of these tools, we also expect to see increased access to other essential molecular tests, such as those used in the diagnosis and management of HIV and tuberculosis, and strengthened local disease surveillance systems."
SD Biosensor and Bioneer both have laboratory-based platforms designed for rapid and accurate diagnosis and have high multiplexing capacity, with the potential for up to 12 targets with SD Biosensor's platform and up to 40 for Bioneer's. Both companies are planning to validate tests for tuberculosis on the same platform.
Biomeme and Qlife are developing systems for use in primary care settings with portable, easy-to-use instruments, FIND said. Biomeme's platform can identify up to 27 targets in a single test, while Qlife's platform can run multiple kinds of assays, including immunoassays and clinical chemistry tests, on the same instrument.
All of the companies have committed to prices of less than $15 for their tests for LMICs.