Clinical Data of The Visby Medical Sexual Health Click Test Published in Journal of the American Sexually Transmitted Diseases Association

SAN JOSE, Calif., Dec. 1, 2021 /PRNewswire/ -- Visby Medical, a leading medical diagnostic company, today announced results from the cross-sectional single visit patient outcomes and implementation study, which evaluated self-collected vaginal swab samples from 55 women using the Visby Medical Sexual Health Click Test for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV).

The results of this IRB-approved study are now published in the journal of Sexually Transmitted Diseases. The study analyzed the ease of integrating the Visby Medical STI panel into clinical practice, and its potential to inform accurate treatment decisions. The study also looked at how the Visby test could reduce time to results, rates of over- and under-treatment, hands-on-time required to run the Visby test by clinic staff, and overall satisfaction for clinicians and patients.

STIs are epidemic in the U.S. The U.S. Centers for Disease Control and Prevention (CDC) reported in April that cases of NG and CT were at an all-time high for the sixth consecutive year.¹ STIs affect everyone: Approximately one in five Americans have an STI, with an estimated prevalence of 26 million new cases annually.² TV infections in 2018 were estimated to be 2.6 million, while 1.8 million CT and over 616,000 NG infections were reported in 2019.^2,3 The increased prevalence of STIs in the U.S. is a clear indicator that fast, accurate results are needed at the point-of-care for proper treatment and management of STI.

STI diagnostic test results are typically not available during the patient visit, therefore, clinicians must make presumptive treatment decisions based on symptoms, which can lead to over- and under-treatment. Rapid and accurate point-of-care results create a better workflow and can play a pivotal role in preventing the misuse of antibiotics by enabling clinicians to select the most effective treatment for the condition. Appropriate use of antibiotics can improve patient health, reduce health care costs, and prolong the utility of effective antibiotics. Inappropriate antibiotic use can contribute to the development of antibiotic resistance. This is one of the greatest global health challenges of modern time, according to the 2019 CDC Antibiotic Resistance threats report.

"Traditional testing for STIs commonly requires large, complex machinery in distant labs and can take days for clinicians to receive results, so that diagnoses and treatment decisions must be made without the benefit of an accurate, data-driven diagnosis," said Visby Medical Founder and CEO Adam de la Zerda, Ph.D. "This publication by a peer-reviewed journal confirms the benefits of adopting the Visby Medical Sexual Health Click test into clinical practice to ensure patients are appropriately treated for CT, NG and TV, and in a timely manner, during a single patient visit."   

Findings from this study showed that treatment for all three infections based on the rapid point-of-care Visby STI test results could have prevented 33 out of 33 cases (100%) of over-treatment and 13 out of 15 cases (86.7%) of under-treatment. Overall, patients were comfortable with self-collecting samples and waiting for test results. Clinic staff were comfortable operating the test, and health care providers valued the single visit test-and-treat model.

About Visby Medical™

Visby Medical is a diagnostics company that is transforming the order of diagnosis and treatment for infectious diseases. The Company's proprietary technology development program culminated in the world's first instrument-free, single-use PCR platform that fits in the palm of your hand and rapidly tests for serious infections. Originally developed for sexually transmitted infections, the Company's FDA-cleared, CLIA-waived Sexual Health Click Test for women returns accurate results within 28 minutes. The Visby Medical technology is also helping to fight the global pandemic via the Visby Medical COVID-19 Test, and its robust pipeline includes tests for other infectious diseases. Visby Medical 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, visit www.visbymedical.com. Follow Visby Medical on LinkedIn; Facebook, and Twitter.

Contact Visby's Media team for any inquiries: [email protected]

Citations:

1. https://www.cdc.gov/nchhstp/newsroom/2021/2019-STD-surveillance-report.html
2. https://www.cdc.gov/std/statistics/prevalence-2020-at-a-glance.htm
3. https://www.cdc.gov/std/statistics/2019/default.htm

SOURCE Visby Medical