Latest news with #VisbyMedicalApp
Yahoo
04-04-2025
- Health
- Yahoo
FDA approves at-home chlamydia, gonorrhea, trichomoniasis test for women
(NewsNation) — The Food and Drug Administration last week gave approval for an at-home chlamydia, gonorrhea and trichomoniasis test for women. Visby Medical Women's Sexual Health Test can be taken by those with or without symptoms,and delivers results in about 30 minutes, the FDA said in a news release. This is the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that can be bought without a prescription and done entirely at home. Last year, the FDA also authorized an at-home syphilis test. '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,'Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA's Center for Devices and Radiological Health, said in a statement. '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.' Tariffs will drive up prices of everyday goods from coffee to toys The Visby Medical Women's Sexual Health Test, according to the FDA, 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, according to the FDA. Adam de la Zerda, the founder and CEO of Visby Medical, said the test was in development for 12 years. 'This approval is not just a milestone for Visby Medical but marks a transformative moment in medical diagnostics,' de la Zerda said in a statement. 'We've achieved something incredible; our palm-sized, single-use PCR test is simple to use and replaces a bulky, large, expensive laboratory instrument.' The test is single-use and includes a collection kit and powered testing device. Once the test is complete, results are shown on the Visby Medical App. 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. More than 600,000 cases of gonorrhea and over 1.6 million cases of chlamydia were reported in the U.S. in 2023, the Centers for Disease Control and Prevention's Sexually Transmitted Infections (STI) Surveillance Report states. Trichomoniasis affected about 2.6 million people in 2021, per the CDC. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
USA Today
28-03-2025
- Health
- USA Today
FDA approves first at-home, over-the-counter test for STIs. But there's a catch.
FDA approves first at-home, over-the-counter test for STIs. But there's a catch. The at-home, over-the-counter test screens for chlamydia, gonorrhea and trichomoniasis. Show Caption Hide Caption Where to get tested for STIs Sexually transmitted infections are on the rise. Here's where to get properly tested. Self Improved, Self Improved The U.S. Food and Drug Administration (FDA) has approved the first-ever testing kit for sexually transmitted infections that can be taken at home without a prescription. But it's not for everyone. The FDA granted marketing authorization for the diagnostic test, the Visby Medical Women's Sexual Health Test, to Visby Medical on Friday. The at-home kit, according to the FDA, is the first of its kind to test for chlamydia, gonorrhea and trichomoniasis, three of the most common STIs with symptoms that often go unnoticed. The kit is intended for use in female patients with or without symptoms. It is single-use and includes a vaginal swab and a powered testing device that connects to the Visby Medical App. Results are displayed on the app about 30 minutes after testing. An FDA press release issued Friday said the test was 97% to 100% accurate when identifying the presence or absence of the three STIs in women with or without symptoms. The release advised that those who test positive should seek medical care and those who have symptoms, recent exposure or other concerns should still contact their healthcare provider even if they get a negative result. '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,' Courtney Lias, director of the Office of In Vitro Diagnostic Devices in the FDA's Center for Devices and Radiological Health, said in a statement. '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.' The approval of this test opens the pathway for more at-home STI testing in the future, said the statement. At-home test tackles three most common STIs Chlamydia, gonorrhea and trichomoniasis are three of the most prevalent STIs in the U.S. Both chlamydia and gonorrhea are bacterial infections, while trichomoniasis is caused by a parasite. Gonorrhea can cause infection in the genitals, rectum and throat and often has no symptoms, according to the Centers for Disease Control and Prevention (CDC). Chlamydia is also typically asymptomatic but can cause permanent damage to a woman's reproductive system. Trichomoniasis is caused by a one-celled protozoan, a type of tiny parasite called Trichomonas vaginalis. In 2021, the CDC reported that around 2.6 million Americans had been infected with trichomoniasis. Up to 70% of people have no symptoms when infected. According to the CDC's (STI) Surveillance Report, 601,319 cases of gonorrhea were reported in the U.S. in 2023, making it the second most common STI in the country. There were more than 1.6 million reported cases of chlamydia in the same year, making it the most common.
Yahoo
28-03-2025
- Health
- Yahoo
US authorizes first home test for three common sexually transmitted infections
(Reuters) -The U.S. Food and Drug Administration on Friday granted authorization to market the first test that can be performed entirely at home for detecting three sexually transmitted infections (STIs). The home test, developed by privately held company Visby Medical, does not require mailing samples to a lab like other existing home-based STI tests. The new test for common STIs chlamydia, gonorrhea, and trichomoniasis, which is intended for females with or without symptoms, delivers results in about 30 minutes. All three infections can be treated with antibiotics, but if left untreated, can cause serious health complications for patients, including infertility, the FDA said. Visby's single-use test includes a collection kit and a powered testing device, which communicates securely with the Visby Medical App to display results when the test is complete. "Expanding access to tests for STIs is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection," said Courtney Lias, director of the Office of In Vitro Diagnostic Devices in the FDA's Center for Devices and Radiological Health. The common STIs caused by different pathogens have distinct symptoms such as painful urination, lower abdominal pain, heavy menstrual bleeding, and itching or irritation in the genital area. More than 2.2 million cases of chlamydia and gonorrhea were diagnosed and reported in the U.S. in 2023, according to a report on STIs from the Centers for Disease Control and Prevention (CDC). It is estimated that trichomoniasis is the most prevalent non-viral STI worldwide, affecting about 2.6 million people in the U.S., according to the CDC. Last year, the FDA authorized the first at-home, over-the-counter test to detect syphilis antibodies in human blood.
Reuters
28-03-2025
- Health
- Reuters
US authorizes first home test for three common sexually transmitted infections
March 28 (Reuters) - The U.S. Food and Drug Administration on Friday granted authorization to market the first test that can be performed entirely at home for detecting three sexually transmitted infections (STIs). The home test, developed by privately held company Visby Medical, does not require mailing samples to a lab like other existing home-based STI tests. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. The new test for common STIs chlamydia, gonorrhea, and trichomoniasis, which is intended for females with or without symptoms, delivers results in about 30 minutes. All three infections can be treated with antibiotics, but if left untreated, can cause serious health complications for patients, including infertility, the FDA said. Visby's single-use test includes a collection kit and a powered testing device, which communicates securely with the Visby Medical App to display results when the test is complete. "Expanding access to tests for STIs is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection," said Courtney Lias, director of the Office of In Vitro Diagnostic Devices in the FDA's Center for Devices and Radiological Health. The common STIs caused by different pathogens have distinct symptoms such as painful urination, lower abdominal pain, heavy menstrual bleeding, and itching or irritation in the genital area. More than 2.2 million cases of chlamydia and gonorrhea were diagnosed and reported in the U.S. in 2023, according to a report, opens new tab on STIs from the Centers for Disease Control and Prevention (CDC). It is estimated that trichomoniasis is the most prevalent non-viral STI worldwide, affecting about 2.6 million people in the U.S., according to the CDC. Last year, the FDA authorized the first at-home, over-the-counter test to detect syphilis antibodies in human blood.
