Female genital tract infection

TUESDAY, April 1, 2025 -- The U.S. Food and Drug Administration granted marketing authorization for the first home-based, nonprescription diagnostic test for chlamydia, gonorrhea, and trichomoniasis in women, the agency announced Friday. Women with or without symptoms can use the Visby Medical Women's Sexual Health Test to test for these three sexually transmitted infections (STIs). Results are delivered in about 30 minutes. The single-use, at-home test includes a self-collected vaginal swab and a powered testing device that provides secure communication to the Visby Medical App. Once complete, the test results are displayed on the app. This approval follows authorization of the first at-home syphilis test last year and authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection in 2023 -- the first FDA-authorized test with at-home sample collection for an STI other than HIV. The approval was based on data showing the Visby Medical Women's Sexual Health Test correctly identified 98.8 and 97.2 percent of negative and positive Chlamydia trachomatis samples; 99.1 and 100 percent of negative and positive Neisseria vaginalis samples; and 98.5 and 97.8 percent of negative and positive Trichomonas vaginalis samples, respectively. The FDA notes that women with positive results should consult with a physician. Those with symptoms, recent STI exposure, or other concerns should undergo additional testing. As with other tests, the main risks of using the Visby test are the possibility of false-negative results, leading to delays in treatment, or false-positive results, leading to unnecessary treatment. "Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection," Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA Center for Devices and Radiological Health, said in an agency news release. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Today's Action also Opens the 510(k) Pathway for Other Home Tests for Sexually Transmitted Infections SILVER SPRING, Md., March 28, 2025 /PRNewswire/ -- Today, the U.S. Food and Drug Administration granted marketing authorization to Visby Medical for the Visby Medical Women's Sexual Health Test. This is the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that can be purchased without a prescription and performed entirely at home. The test is intended for females with or without symptoms and delivers results in approximately 30 minutes. "Home tests can give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment," said Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA's Center for Devices and Radiological Health. "Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection." According to the Centers for Disease Control and Prevention's Sexually Transmitted Infections (STI) Surveillance Report, more than 2.2 million cases of chlamydia and gonorrhea were diagnosed and reported in the U.S. in 2023. Additionally, it is estimated that trichomoniasis is the most prevalent nonviral STI worldwide, affecting approximately 2.6 million people in the U.S., according to the CDC's treatment guidelines. Typically, all three infections can be treated with antibiotics, but if left untreated, can cause serious health complications for patients, including infertility. The Visby Medical Women's Sexual Health Test is a single use, at home test, that includes a collection kit (self-collected vaginal swab) and a powered testing device, which communicates securely to the Visby Medical App, which displays results when the test is complete. In individuals with and without symptoms, the Visby Medical Women's Sexual Health Test correctly identified 98.8% of negative and 97.2% of positive Chlamydia trachomatis samples, 99.1% of negative and 100% of positive Neisseria gonorrhoeae samples and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples. Individuals with positive results for any of the three infections should seek medical care. Individuals with symptoms, recent exposure to an STI or other concerns despite a negative result should contact their health care provider for additional testing. As with many other tests, the risks associated with this test are mainly the possibility of false positive and false negative test results. False negative test results can result in delays to effective treatment and spread of infection to other persons. False positive results could lead to unnecessary treatment and/or a delay in receiving a correct diagnosis and appropriate treatment. The FDA reviewed this test under the FDA's De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA's 510(k) premarket notification process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device, which may save a developer time and expense compared to other review pathways. This announcement follows last year's authorization of the first at-home syphilis test, as well as the authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection in 2023, which was the first FDA-authorized test with at-home sample collection for any sexually transmitted infection other than HIV. Media Contact: James McKinney, 240-328-7305 Consumer Inquiries: [email protected], 888-INFO-FDA The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. SOURCE U.S. Food and Drug Administration WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

-- Allowed Patent Extends SOLOSEC IP to 2040 with Broad Claims that are Orange Book-listable -- SAN DIEGO, Feb. 13, 2025 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) today announced that the United States Patent and Trademark Office (USPTO) issued to the Company a Notice of Allowance for patent application 17/028,838, entitled "Method and Pharmaceutical Composition for Treating or Preventing Trichomoniasis and Uses Thereof." This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed. "This new U.S. patent extends SOLOSEC's IP protection by a full five years, from 2035 to 2040," said Saundra Pelletier, Chief Executive Officer of Evofem. "This extension, for the treatment of trichomoniasis, significantly benefits prescribers, patients, and our investors with a longer opportunity to build the SOLOSEC brand with its single-dose regimen." The allowed patent application is directed to treatment of Trichomonas vaginalis infections (trichomoniasis) with SOLOSEC® (secnidazole) 2 g oral granules, with broad claims centered on pharmacokinetics and formulation features of Evofem's single-dose oral antimicrobial agent. Evofem expects the resulting patent will be Orange Book-listable. Trichomoniasis is the most common non-viral sexually transmitted infection in the world. There are an estimated 6.9 million new infections with T. vaginalis in the U.S. each year.1 Undiagnosed infections and lack of compliance with multi-day treatment regimens are critical contributing factors. All sexual partners of people infected with trichomoniasis should be treated with the same dose and at the same time to prevent reinfection. SOLOSEC® is designed to be easy to take; one oral dose contains a complete course of treatment. SOLOSEC is the first and only single-dose oral antibiotic FDA-approved to treat bacterial vaginosis (BV) in females 12 years of age and older as well as trichomoniasis in people 12 years of age and older. Evofem acquired global rights to the product in July 2024 and relaunched SOLOSEC in the U.S. in November 2024 with its women's health-focused commercial team. About Trichomoniasis Trichomoniasis (or "Trich") is a sexually transmitted infection (STI) caused by infection with Trichomonas vaginalis, a protozoan parasite. It is the most common nonviral STI globally. Up to 70% of people infected with Trich are unaware that they are infected and may unwittingly pass the parasite to sexual partners. Untreated infections might last from months to years. In women, Trich can cause a foul-smelling vaginal discharge, genital itching, and pain with urination or sex. Trich is also associated with an increased risk for cervical cancer, HIV acquisition, and, among women with HIV infection, pelvic inflammatory disease (PID). Pregnant women who have Trich may be at higher risk of delivering their babies prematurely. Men who have Trich typically have no symptoms, however when men do have symptoms these may include itching or irritation inside the penis, burning with urination or after ejaculation, and discharge from the penis.2 About Evofem Biosciences Evofem is commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, PHEXXI® (lactic acid, citric acid, and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. In July 2024 Evofem broadened its commercial offering with the acquisition of SOLOSEC® (secnidazole) 2g oral granules, an FDA-approved oral antibiotic for the treatment of two sexual health diseases: bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose. Follow us on: LinkedIn: Facebook: X (f/k/a Twitter): PHEXXI® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc. Forward-Looking Statements This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 27, 2024, Quarterly Report on Form 10-Q for the three months ended September 30, 2024 filed with the SEC on November 14, 2024, and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law. Contact Amy Raskopf, Chief Business Development Officer Evofem Biosciences, Inc. [email protected] (917) 673-5775 Sources Kreisel KM et al. Sexually Transmitted Infections Among US Women and Men: Prevalence and Incidence Estimates, 2018. Sex Transm Dis. 2021 Apr 1;48(4):208-214. doi: 10.1097/OLQ.0000000000001355. PMID: 33492089; PMCID: PMC10245608. Mayo Clinic. Diseases & Conditions: Trichomoniasis. 17 May 2022. Accessed 5 Nov 2024 at . SOURCE Evofem Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED