Point-of-Care test significantly shortens time from ED arrival to test results, treatment and discharge significant improvements are seen in the use of antibiotics for the treatment of chlamydia and gonococcal infections in women

Nationwide increases in sexually transmitted diseases and antibiotic resistance create the need for a paradigm shift from traditional lab-based molecular testing

SAN JOSE, Calif., May 30, 2024 /PRNewswire/ -- Visby Medical and the Johns Hopkins Medicine Department of Emergency Medicine announced findings froma study evaluating a new approach to management of the three most common non-viral sexually transmitted infections (STI) in women. The study found that use of the Visby Medical Sexual Health Test, a point-of-care (POC) polymerase chain reaction (PCR) test, shortened time from specimen collection to STI result to only 47 minutes per patient, compared to an average of 25 hours for the standard of care (SOC) lab-processed molecular send-out tests. The Visby Medical test also resulted in significantly higher rates of appropriate treatment and lower rates of over-treatment with antibiotics for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections, compared to SOCi.Full data were presented on May 17 at the 2024 annual meeting of the Society for Academic Emergency Medicine (SAEM).

The Visby Medical Sexual Health Test is the only "instrument-free" POC test available in the U.S. that provides PCR results in under 30 minutes. In March 2023, the Visby Medical test received 510(k) clearance and was granted a CLIA waiver from the U.S. Food and Drug Administration for its second-generation POC test.

An STI surveillance report published in 2024 by the U.S. Centers for Disease Control (CDC) found more than 2.5 million cases in 2022ii. At the same time, the rate of inappropriate use of antibiotics to treat STIs has contributed to antimicrobial resistant strains of NG, prompting the World Health Organization (WHO) to release new guidance to improve diagnosis of STIs, including POC tests, with special emphasis on reducing antimicrobial resistanceiii.

"The rise in STIs has created a crisis for the nation's hospital emergency departments because the conventional send out tests do not provide results fast enough to inform treatment decisions during the patient visit. Rather than lose a potentially infected patient, clinicians must decide whether to treat before they have definitive results, which isn't ideal for anyone and contributes to antibiotic resistance," explained Gary Schoolnik, MD, an infectious disease expert, Chief Medical Officer at Visby Medical, and Professor of Medicine at Stanford University. "The dramatic improvements seen with the Visby Sexual Health test in testing time, ED visit duration, and in the use of antibiotics point the way toward a new best practice for STI testing. Implementation of a new rapid point-of-care testing standard of care would greatly benefit our hospitals, urgent care centers and, most importantly, women who seek treatment for this condition."

The study, Management of Sexually Transmitted Infections in the Emergency Department: Evaluation of a Point-of-care Test, compared two approaches to testing female patients presenting to the Johns Hopkins Emergency Department in Baltimore, MD with potential STIs during two separate four-month study periods in 2022 and 2023. The first approach, SOC central laboratory testing with batched nucleic acid amplification testing (NAAT) (n=517 patients), and the second approach, the POC PCR Visby Medical Sexual Health Test (n=304 patients), were compared for rates of STIs identified, median time-to-result intervals between the two phases, and rates of appropriate treatment (including over and under treatment) based on CDC recommended guidelines.

For patients testing positive (4.8% for CT, 2.7% for NG, 8.0% for trichomoniasis [TV], and 1.9% with co-infections), proportions of appropriate treatment were significantly higher among the POC group for CT (92.7% vs 75.1% p<0.001) and NG (87.1% vs 74.3% p<0.001). Proportions of over-treatment were significantly lower among the POC group for CT-negative (7.0% vs 25.2% p<0.001) and NG-negative (13.0% vs 25.5% p<0.001) patients. No significant differences between the two testing groups were seen for TV. Median time intervals were significantly lower for the POC group, including time from specimen collection to STI results (47.0 minutes vs 25 hours p<0.001), time from ED arrival to STI results (5.7 hours vs 33.9 hours p<0.001), and time from ED arrival to discharge (9.1 hours vs 11.9 hours p<0.001)iv.

The study was conducted by researchers at Johns Hopkins Universitywith support fromVisby Medical.

About Visby Medical Visby Medical is transforming the order of diagnosis and treatment for infectious diseases so clinicians can test, talk with, and treat the patient in a single visit. The Company developed a proprietary technology platform that is the world's first instrument-free, single-use PCR platform that fits in the palm of your hand and rapidly tests for serious infections.

The Visby Medical Sexual Health Test for women is the first step in a robust pipeline that is accelerating the delivery of fast and accurate, palm-sized PCR diagnostics to the point of care, and eventually for use at home. For more information, visitwww.visbymedical.com. Follow Visby Medical onLinkedIn.

Media Contact: Harry Wade [emailprotected] 917-482-9057

iKendall N. Maliszewski BS, Management of Sexually Transmitted Infections in the Emergency Department: Evaluation of a Point-of-care Test. Paper presented at the 2024 annual meeting of the Society for Academic Emergency Medicine, May 14-17 2024, Phoenix, AZ. iiCDC, CDC's 2022 STI Surveillance Report underscores that STIs must be a public health priority. Available here: https://www.cdc.gov/std/statistics/2022/default.htm. iii WHO Announcement: WHO releases new guidance to improve testing and diagnosis of sexually transmitted infections, 24 July 2023. Available here: https://www.who.int/news/item/24-07-2023-who-releases-new-guidance-to-improve-testing-and-diagnosis-of-sexually-transmitted-infections. ivKendall, Management of Sexually Transmitted Infections.

SOURCE Visby Medical

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