Rapid diagnostic for gonorrhea wins $19 million federal prize competition to combat antibiotic resistance

Colorized scanning electron micrograph of Neisseria gonorrhoeae bacteria, which causes gonorrhea. NIAID

A diagnostic test capable of accurately and reliably detecting the microorganism that causes gonorrhea and rapidly determining in under 30 minutes if the microorganism is susceptible to a single-dose antibiotic is the winner of the Antimicrobial Resistance (AMR) Diagnostic Challenge. Visby Medical, Inc., will receive $19 million as a prize for its winning diagnostic.

According to the Centers for Disease Control and Prevention, more than 2.8 million antibiotic-resistant infections occur in the United States each year, and more than 35,000 people die as a result. The AMR Diagnostic Challenge is co-sponsored by the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) of the HHS Office of the Assistant Secretary for Preparedness and Response, with each contributing $10 million over the course of the competition.

“Antibiotic-resistant bacteria are a growing and concerning public health risk against which we have few effective deterrents,” said NIH Director Francis S. Collins, M.D., Ph.D. “Challenge prizes spur innovation and we saw many innovative concepts throughout this competition. I want to congratulate Visby Medical for their winning technology, which could help reduce the unnecessary use of antibiotics, a major driver of antimicrobial resistance.”

“One of the challenges healthcare providers face in combating the growing threat of antimicrobial resistant infections is identifying which drugs will be effective in treating the initial infection, and fixing that problem starts with rapid, accurate, easy-to-use, point of care diagnostics,” said BARDA Acting Director Gary Disbrow, Ph.D. “Innovative technologies that can rapidly detect and diagnose drug resistant infections have the potential to measurably improve our response in a public health emergency caused by a drug resistant pathogen. Congratulations to Visby Medical on their winning technology.”

The company’s diagnostic, known as Patient-side, Disposable, Molecular PCR Diagnostic Device for Neisseria gonorrhoeae and Drug Resistance Markers, is a palm-size, single-use, disposable device for the detection of Neisseria gonorrhoeae (N. gonorrhoeae), the microorganism that causes gonorrhea. This diagnostic gives results quickly, allowing clinicians to treat patients immediately and with the correct medication. Gonorrhea is one of the most frequently seen sexually transmitted infections (STIs), which represent a major public health crisis worldwide and in the United States. There were more than 580,000 cases of gonorrhea reported nationwide in 2018 according to the CDC, a 63% increase from 2014.

This type of rapid testing that includes assessment of antibiotic susceptibility has not been available previously as a point-of-care diagnostic device. Antimicrobial resistance in gonorrhea is of increasing concern, and successful treatment of gonorrhea is becoming more difficult. Treatment options have been limited to two drugs, requiring an injection of one drug plus an oral antibiotic.

If approved by the U.S. Food and Drug Administration, the Visby Medical device could be useful in ensuring that patients with gonorrhea receive the right antibiotic so that they can immediately begin treatment, and will allow other antibiotics to be used for patients with drug resistant strains of N. gonorrhoeae.

The easy-to-use format of the device could be helpful in STI clinics, walk-in/urgent care clinics and other facilities without extensive hands-on laboratory staff. Ultimately, this device could have a significant impact in addressing the increasing incidence of gonorrhea and the increasing spread of drug resistant forms of this common STI in the United States and worldwide. Visby Medical currently is exploring how its proprietary technology platform could be adapted to aid in the development of diagnostics for SARS-CoV-2, the virus that causes COVID-19.

The winning diagnostic was chosen from a group of five semifinalists who each received $100,000 in Step 2 of the competition to develop and test prototypes to improve detection of drug-resistant bacteria or differentiate between a bacterial and viral infection. For more information on Visby Medical’s submission and the AMR Diagnostic Challenge, visit: https://dpcpsi.nih.gov/AMRChallenge.

About HHS, ASPR, and BARDA: HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures — vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 55 FDA approvals, licensures or clearances. To learn more, visit https://www.phe.gov/about/BARDA/Pages/default.aspx(link is external).

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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