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CARB-X Awards $1M Each to Prompt Diagnostics, Fuse Diagnostics for Point-of-Care STI Tests

NEW YORK – The nonprofit organization Combatting Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) announced on Thursday that it has awarded $1 million to Prompt Diagnostics for the development of a portable multiplex testing platform and a test that could be used to detect the pathogen that causes gonorrhea and characterize the pathogen's drug susceptibility.

The organization also announced earlier this month that it was awarding $1 million to Fuse Diagnostics for proof-of-concept and feasibility testing of the firm's rapid, instrument-free test for the pathogens that cause gonorrhea and chlamydia.

Baltimore-based Prompt Diagnostics will use its award to support the development and commercialization of the company's Prompt point-of-care PCR testing platform and to demonstrate the feasibility of detecting the presence of Neisseria gonorrhoeae and mutations that are connected with resistance to ceftriaxone and other antibiotics. Test results would be used to guide treatment and management as well as to reduce the selection for and spread of multidrug-resistant gonorrhea.

CARB-X Chief Erin Duffy said in a statement that ceftriaxone-resistant gonorrhea poses a significant and growing threat to public health.

"Rapid, sophisticated diagnostics are essential to addressing drug-resistant bacterial infections globally as they detect infections as early as possible while also directing healthcare providers to the most appropriate treatment," she said. "We are enthusiastically partnering with Prompt to better understand the capabilities of their PCR platform and how it could support decentralized rapid ID and susceptibility testing for all of the major classes of antibiotics."

The company is designing its cartridge-based diagnostics platform to provide rapid, inexpensive, and easy-to-use molecular testing in low-resource areas such as remote settings or those with limited access to secondary healthcare facilities. CARB-X noted that the World Health Organization estimated about 82 million people developed gonorrhea infections in 2020, with cases occurring at higher rates in low- and middle-income countries that also tend to have a higher burden of drug resistance.

Fuse Diagnostics will use its award to demonstrate the performance of its Apex CT/NG molecular test for the detection of N. gonorrhoeae and Chlamydia trachomatis in clinical samples. The firm said on its website that its test uses proprietary multi-analytic amplification chemistries to develop small, low-cost, disposable tests.

Fuse said in the announcement that its tests deliver PCR-equivalent accuracy in a rapid, low-cost format that would be suitable for use in remote areas of low- and middle-income countries.

"We need rapid diagnostics that allow healthcare workers to test and treat gonorrhea out of the gate, as inappropriate treatment has led to the point that only one effective antibiotic remains," Duffy said in a statement.

Prompt and Fuse are two of the four companies that have received awards from CARB-X through its 2022-2023 funding call. CARB-X also awarded in April $1 million to the diagnostics company Scout for its development of a 30-minute molecular test for N. gonorrhoeae and C. trachomatis, and it awarded in February at least $1.8 million to Visby Medical for the development of a portable PCR test for N. gonorrhoeae and susceptibility to ciprofloxacin.