Syphilis, Congenital

STONE HARBOR, N.J., March 13, 2024 /PRNewswire/ -- Diagnostics Direct LLC, a leading provider of diagnostic testing solutions, is proud to announce the formation of its distinguished Medical Advisory Board. The Board was established to aid the company in their efforts to enhance syphilis diagnosis and care, as well as identify areas needing specific attention. Norman Proulx, Co-Founder and CEO, emphasized the company's dedication to broadening access to Syphilis Health Check™ for underserved groups, including newborns and those seeking self-testing options. Continue Reading Diagnostics Direct proudly announces the formation of its Medical Advisory Board, comprised of highly respected experts in the field of sexually transmitted infections (STIs) diagnosis and treatment. "With Syphilis Health Check being the sole FDA 510(k) cleared and CLIA Waived rapid syphilis test on the market for more than a decade, our goal is to adapt it for newborn testing and expand its reach through self-testing. These initiatives are fully backed and advanced by our Board members." The newly formed Advisory Board is comprised of highly respected experts in the field of sexually transmitted infections (STIs) diagnosis and treatment: Dr. Jeffrey Klausner, MD, MPH, a renowned Clinical Professor of Medicine, Infectious Diseases, and Public Health at the Keck School of Medicine, USC. Dr. Leandro Mena, MD, MPH, FIDSA, the distinguished former Director of the Division of STD Prevention (DSTDP) at the Centers for Disease Control and Prevention (CDC). Dr. Irene Stafford, MD, MS, a respected board-certified maternal and fetal specialist at the University of Texas Health Science Center in Houston (Children's Memorial Hermann Hospital). Board members have expressed their enthusiasm for the impact they can have on the syphilis epidemic by working with Diagnostics Direct: Dr. Jeffrey Klausner remarked, "I am pleased to lead the Diagnostics Direct Medical Advisory Board. We urgently need innovative companies like Diagnostics Direct to be at the table to help health officials and doctors address the congenital syphilis crisis. We have an Advisory Board with deep expertise in syphilis and the public health response which will make it easier to get the tests out to those who need it most." Dr. Irene A. Stafford added, "I am excited to work on new innovative and patient-centered approaches to target maternal and congenital syphilis with my team of experts at Diagnostics Direct." Dr. Leandro Mena shared, "I am thrilled to join the Diagnostics Direct Medical Advisory Board, where our shared dedication to revolutionizing point-of-care testing and enhancing syphilis diagnostics is key. Early diagnosis and prompt treatment are vital for improving sexual health. With our collective expertise, we're committed to advancing diagnostic solutions that meet the evolving needs of healthcare providers and patients." The formation of the Medical Advisory Board by Diagnostics Direct signifies a major step forward in combating the spread of syphilis through innovative, accessible testing solutions. This initiative aligns with the company's mission to improve public health outcomes through cutting-edge diagnostics. About Syphilis Health Check™: Syphilis Health Check™ is the first and only FDA CLIA-Waived rapid treponemal syphilis test. Using just a single drop of whole blood from a finger stick, results are available in as little as 10 minutes. The U.S. Food and Drug Administration granted the CLIA Waiver for Syphilis Health Check in 2014. About Diagnostics Direct, LLC: Diagnostics Direct, LLC, is a leader in the development and distribution of diagnostic tests for sexually transmitted infections with a focus on providing accessible, high-quality testing solutions for healthcare providers and patients alike. For prompt results and immediate patient care, trust Diagnostics Direct. Visit for more information or to request samples. SOURCE Diagnostics Direct, LLC.

HALIFAX, NS / ACCESSWIRE / February 1, 2024 / Today, MedMira Inc. (MedMira) (TSXV:MIR) is pleased to provide an update on the ongoing review process by Health Canada. The Company made the required submission and has been working towards extending its intended use highlighting the increasing need in maternity screening. MedMira is committed to provide the fastest and most accurate solution to the increasing infection rates for infectious and congenital syphilis. Whereas the infection rates over the past 10 years increased by 73% among males, the rate among females increased by 773%. As a result, congenital syphilis (syphilis transmitted during pregnancy to babies) led to a rise in severe and life-threatening illnesses with up to 40% of babies being stillborn. The Company's syphilis component showcased an overall performance of a PPA of 86.0% (95% CI 82.7-88.8%) and an NPA of 99.5% (98.8-99.8%). Notably, when the RPR titre was > 1:8 dilutions-indicative of an infectious case-the performance significantly improved to a PPA of 98.3% (95.7-99.3%) and an NPA of 99.5% (98.8-99.8%). This is particularly promising as it aligns with the marker for newly diagnosed infectious syphilis cases the study. Furthermore, in a subset analysis involving specimens from women at various pregnancy stages, the MedMira's test exhibited high quality results. Specifically, the test accurately identified all previously syphilis-infected cases, demonstrated reliability in confirming negatives, and presented potential for maternity screening. In order to demonstrate this, the Company expanded its overall data pool with additional specimens including those from various pregnancy stages among negative and positive syphilis cases. This is the final comprehensive data set to be submitted by the end of February 2024 for the additional claims approval. "We are excited about the data achieved which underline the high quality of our products. It is my firm believe that the data will be a positive proof our capability and quality, not only for regulators but also for our future customers." said Hermes Chan, CEO of MedMira. "We remain committed to advancing healthcare solutions in Canada and we look forward to the positive impact our tests can have on public health." About MedMira MedMira is a leading developer and manufacturer of Rapid Vertical Flow® diagnostics. The Company's tests provide hospitals, labs, clinics and individuals with instant disease diagnosis, such as HIV, Syphilis, Hepatitis, and SARS-CoV-2, in just three easy steps. The Company's tests are sold globally under the REVEAL®, REVEALCOVID-19®, Multiplo® and Miriad® brands. Based on its patented Rapid Vertical Flow® Technology, MedMira's rapid HIV test is the only one in the world to achieve regulatory approvals in Canada, the United States, China and the European Union. MedMira's corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada. For more information visit medmira.com. Follow us on Twitter and LinkedIn. This news release contains forward‐looking statements, which involve risk and uncertainties and reflect the Company's current expectation regarding future events, including statements regarding possible regulatory approval, product launch, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. MedMira Contact Markus Meile Chief Financial Officer MedMira Inc. ir@medmira.com SOURCE: MedMira, Inc. View the original press release on accesswire.com

TUESDAY, Jan. 30, 2024 -- U.S. cases of syphilis have soared past numbers seen just a decade ago, new government statistics show. The grim numbers are for 2022, the latest year for which an accurate tally is available. More than 202,000 cases were recorded among Americans that year -- a 17% rise over 2021 numbers and an 80% rise over numbers recorded in 2018, the report from the U.S. Centers for Disease Control and Prevention found. Congenital syphilis -- when the disease is passed from a mother to her newborn -- can be very harmful to infants, and those cases have also risen at an alarming rate. Over 3,700 such cases were reported in 2022, the CDC reported in November , including 231 stillbirths and 51 infant deaths. Left untreated, syphilis in adults can damage the heart and brain and cause blindness, deafness and paralysis. Why the steady, sharp rise in cases? Experts believe that reductions in condom use have occurred as more Americans are turning to drug regimens that effectively prevent HIV infections without condoms. According to the New York Times , condom use by high school students has fallen by 8 percentage points between 2011 and 2021. The number of clinics focused on sexual health has also declined nationwide, experts say. “Sexual health services remain inadequate relative to the need pretty much everywhere,” Dr. Jay Varma , chief medical officer at Siga Technologies and a former deputy commissioner of health for New York City, told the Times . “But it’s particularly a problem here in the United States,” Varma said. “When you miss one case, you then end up with two more cases, and if you miss two cases, you then end up with four. That’s how epidemics grow.” Outbreaks can happen anywhere. According to the new report, South Dakota recorded the highest rate of syphilis infections in 2022 of any state, followed by New Mexico. Arkansas, Oklahoma and Mississippi took the third, fourth and fifth spots on that list. Race and ethnicity left some populations more vulnerable. A full 30% of cases occurred among Black Americans, while Native American/Alaska Natives had the highest rate of any ethnic group, at 67 cases per 100,000. The crisis has been compounded by a shortage of drugs crucial to treating syphilis. Bicillin , a long-acting injectable form of penicillin made by Pfizer, has been in short supply in the United States since the middle of 2023. It is the recommended treatment for syphilis in adults and it’s the only recommended treatment for pregnant women to prevent syphilis passing from mother to newborn. Earlier this month, the U.S. Food and Drug Administration said it would allow the importation of a different syphilis drug from a French drugmaker. In a letter from Laboratoires Delbert, the Paris-based company said it’s working with the FDA to temporarily import 3.5 million units of Extencilline, which is not approved for use in the United States. The CDC has also recommended that people at higher risk for syphilis take the antibiotic doxycycline after unprotected sexual encounters. Studies have shown that taking the antibiotic doxycycline within 72 hours of sex might help prevent a sexually transmitted infection. Dr. Jonathan Mermin directs the National Center for HIV, Viral Hepatitis, STD and TB Prevention at the CDC. Speaking to the Times , he said the CDC is also pushing research into a simple test for syphilis that can be used at clinics and might be available within the next two years. He believes that curbing the ongoing epidemic of syphilis will require organized efforts by doctors, hospitals, community health centers and drug treatment programs. “Wishing hard won’t prevent sexually transmitted infections,” Mermin said. “We need sustained public health efforts.” Sources Sexually Transmitted Infections Surveillance, Jan. 30, 2024 New York Times Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.