Rapid Test for Gonorrhea Wins $19 Million Prize Competition

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 NIH 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 Dr. Francis Collins. “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 health care 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 Dr. Gary Disbrow. “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.”

The company’s diagnostic is a palm-size, single-use, disposable device for the detection of Neisseria 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, 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 percent increase  from 2014.

If approved by the FDA, the new 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.