Reproductive Tract Infections

One in three women who tested positive for chlamydia or gonorrhea while pregnant were not retested before giving birth, despite potential to transmit infections to newborns SECAUCUS, N.J., Aug. 12, 2024 /PRNewswire/ -- A new study by researchers from Quest Diagnostics (NYSE: DGX) and the University of Alabama suggests adherence to guideline-based laboratory testing and treatment of pregnant women for two of the most prevalent sexually transmitted infections (STIs) is suboptimal in the United States, with potentially dire effects on maternal and newborn health. The study, titled Chlamydia and gonorrhea testing in pregnancy: Time to improve adherence and update recommendations, was published in the peer reviewed Journal of Lower Genital Tract Disease, the official journal of the American Society for Colposcopy and Cervical Pathology. It is based on deidentified results of lab tests performed by Quest in all 50 states and the District of Columbia for 4,077,212 pregnancies. The findings suggest gaps in guideline-based care, intended to reduce the risk of infection and medical complications. Untreated chlamydia and gonorrhea can raise risks of infertility and pelvic inflammatory disease in women. The risk of transmission during birth is approximately 50%, raising the potential for newborns to develop infections of the eye (conjunctivitis), lungs (pneumonia) and other health problems. "Our study adds to a troubling body of evidence highlighting inconsistent quality in maternal and child healthcare in the U.S.," said Damian P. Alagia, MD, co-author of the study and Medical Director of Women's Health at Quest Diagnostics. "Our analysis shows that improved adherence to existing recommendations, harmonization of guidelines across agencies, and even updated recommendations for STI testing will be critical to ensuring the mothers and babies in the United States receive medically appropriate testing and treatment." Key findings: Over 4% of women who received guideline-based screening for chlamydia or gonorrhea in pregnancy during the first trimester received a positive result for one or both infections. More than one in three of these women (35.1% chlamydia; 36.9% gonorrhea) did not receive a follow up negative test before delivery, suggesting they may not have been treated and cured (or were treated, cured but then reinfected) before birth. About 2% of patients who received a negative test result for chlamydia or gonorrhea early in pregnancy later received a positive result, suggesting "an ongoing risk of infection during pregnancy". Of these, about one in two were still positive prior to delivery. (53.0% chlamydia and 49.3% gonorrhea). The authors believe reinfections (or ineffectively treated initial infections) may result in an increased number of deliveries while women are positive with one or more STIs, which can impact both maternal and newborn health. The authors conclude current guidelines are inconsistent and they provide several recommendations for improvements. For instance, the CDC recommends women be retested for cure at 4 weeks of pregnancy while the USPSTF recommends retesting before 3 weeks. Current guidelines also do not recommend screening women after the age of 25 years unless there are risk factors (such as multiple partners), based on a study from 1998 when women married at younger ages than today. Guidelines recommend that all women under the age of 25 be screened, regardless of perceived risk. The study's strengths include its large size, national representation, and use of objective laboratory data. Its limitation is the lack of clinical follow-up information for the positive cases, as testing was limited to one national clinical laboratory. While the authors did not evaluate other STIs, such as syphilis, they caution these patterns of irregular adherence to guideline-based testing in maternal care may extend to other conditions. According to the Centers for Disease Control and Prevention (CDC), cases of sexually transmitted disease are at an all-time high, with more than 2.5 million cases of syphilis, gonorrhea, and chlamydia reported in the United States in 2022. About Quest Diagnostics Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. . For more Quest Diagnostics Health Trends® reports, visit . SOURCE Quest Diagnostics

VALENCIA, Spain, March 4, 2024 /PRNewswire/ -- The emotional impact of a human papillomavirus (HPV) diagnosis is significant, often leading to feelings of fear, worry, guilt, and self-stigmatization among women. Recognizing the importance of addressing these emotions alongside physical symptoms, Procare Health organized the third 'HPV TALKS' session on the International HPV Awareness Day. Led by Dr. Raquel Tulleuda, a gynaecologist, and Ms. Vanesa Falcón, a psychologist, the session emphasized the holistic approach needed to manage HPV, focusing on emotional well-being alongside medical treatment. Experts highlighted the complexity of emotions faced by patients, stressing the importance of open communication and seeking support from both partners and healthcare professionals to navigate the diagnosis effectively. They emphasized the crucial role of psychological intervention in managing these emotions, given the insufficient information often provided during gynecological consultations. The session also discussed proactive strategies for HPV management, including the use of Papilocare® products. Clinical trials involving over 600 patients demonstrated Papilocare® vaginal gel's efficacy in normalizing cervical lesions and clearing high-risk HPV strains. Notable studies as the Paloma clinical trial, published in the American scientific journal Journal of Lower Genital Tract Diseases, or the observational study Papilobs , published last July in the prestigious journal Cancers consistently showed significant improvements with Papilocare® treatment: An 88% normalization rate of low-grade cervical lesions in patients with high-risk HPV after six months of Papilocare® treatment, compared to only 56% in untreated individuals. A 63% negative high-risk HPV test rate post-treatment among Papilocare® users, contrasting with 40% in the control group. To address the emotional aspect of HPV management, the experts provided six key habits for patients: Communicate openly about the diagnosis. Seek reliable information about HPV. Take proactive steps, including following efficient non-invasive treatments. Express emotions to trusted individuals. Practice relaxation techniques to reduce anxiety. Maintain a healthy lifestyle to bolster immune function and overall well-being. Procare Health, dedicated to women's health, emphasizes scientific evidence and clinical efficacy in its products. With a focus on international expansion, the laboratory conducts extensive research and clinical trials to provide innovative solutions for women's health issues. In conclusion, the program underscores the importance of addressing the emotional impact of HPV alongside medical treatment. By adopting a holistic approach and implementing proactive strategies, patients can better manage the psychological aspects of the condition, ultimately improving their overall well-being. Video link: Photo:

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  FDA's Peter Marks has no "imminent plans for departure" Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., was forthright but understated when describing the last few years leading the FDA’s Center for Biologics Evaluation and Research, calling the period “challenging,” in an interview. But like any good high-ranking public servant, he dolloped on some positive spin, describing a moment defined by COVID, former President Donald Trump, turnover, stress, scrutiny, variants and remote work as an “incredible learning experience.”  Nobody is losing sleep because a really high-profile figure had to deal with a lot. But suffice to say, Marks has had plenty on his plate running an FDA center that oversees the approval of new cell and gene therapies and neurological products, among other responsibilities. And for now, he’s pressing ahead, saying he has no plans to step away.  “Am I going to be doing this forever? Probably not,” Marks said. “On the other hand, I don't have any imminent plans for departure, in part because every day I wake up and there's some new, interesting thing to help move forward.” He added that so long as he feels like his contribution is benefiting patients, he’ll stay on. But the 11-year veteran on the agency had a caveat, one that’s been informed by his growing number of years around politicians, saying that he knows “to not be too definitive about these kinds of things.” UAB infectious disease division head Jeanne Marrazzo tapped to replace Anthony Fauci National Institute of Allergy and Infectious Diseases Hear ye, hear ye, a formal successor to Anthony Fauci, M.D., has been named!  Months after the longtime public health official stepped down from his post leading the National Institutes of Health's (NIH’s) infectious disease division, NIH interim chief Lawrence Tabak, Ph.D., has named Jeanne Marrazzo, M.D., as the new leader. Marrazzo is currently the head of the infectious disease division at the University of Alabama at Birmingham and is expected to join in the fall. Longevity in leadership positions within government seem like a rarity these days, as politician and polarization cripple once non-partisan posts. But Fauci was an outlier, serving 38 years as the director of National Institute of Allergy and Infectious Diseases, a tenure that spanned seven presidents, Republican and Democrat alike. But his biggest test would be his last, grappling with the rise and spread of COVID-19, advocating for mitigation policies that ultimately became a line in the sand for millions of Americans, largely on party lines. Fauci also became President Joe Biden’s chief medical adviser before retiring at the end of 2022.  Marrazzo’s research has centered on the human microbiome and how it impacts female reproductive tract infections and hormonal birth control, according to a release from the NIH, in addition to studying other sexually transmitted infections. She’s been a principal investigator on NIH grants for more than 25 years and was the presented with the American Sexually Transmitted Diseases Association’s Distinguished Career Award in 2022. Release Former EQRx finance chief takes same role at Boundless Boundless Bio Jami Rubin’s two-month stint as a venture partner at ARCH is caput after the former EQRx CFO took the same role at San Diego biotech Boundless Bio. Let’s hope for her sake that she was able to make it up to Absolute Bagels off 108th Street or a slice of pizza at John’s on Bleeker during her return to New York City. (She spent years there before jumping to biotech.) Rubin left EQRx in March 2023, right around the time that the company instituted a first round of layoffs resulting in cuts to 18% of the team. But it turns out that was only the beginning of a major overhaul for the Alexis Borisy-founded company. A couple of months later, another round of layoffs sent more than half of the company out the door, along with EQRx’s larger strategy of producing low-cost cancer treatments. This week EQRx announced it was being sold to announcer Borisy biotech, Revolution Medicines.  It’s unknown whether Rubin saw the writing on the wall in March or whether the timing of her departure was sheer luck. But regardless, she’s onto greener pastures. Boundless is similarly focused on treating cancer, with a particular emphasis on oncogene-amplified tumors. And while EQRx was shrinking, Boundless was raising new cash, closing another nine-digit round in May. Source > OMass Therapeutics has appointed Peter Phillips, M.D., Ph.D., to the job of SVP of clinical development and Julia Sampson, Ph.D., to serve as VP of nonclinical development. Before filling the newly created positions, Phillips was at Evelo Biosciences and has a track record at NovalGen, UCB, GSK, Novartis and Pfizer, while Sampson has worked across Kalvista Pharmaceuticals, AstraZeneca, Shire Pharmaceuticals, OSI Pharmaceuticals and GW Pharmaceuticals. Release > Catena Biosciences is bringing on two new leaders for its executive team: Saurabh Johri to serve as chief business officer and Rick Kendall, Ph.D., to fill the role of chief scientific officer. Johri joins from Bayer, where he most recently was VP and global head of oncology strategy and early commercialization, while Kendall was most recently president and CEO of ImmPACT BIO, clocking in time before that at Kite Pharma and Amgen. Release > ImmunoGen Chief Medical Officer and SVP Anna Berkenblit, M.D., is exiting the company for a “professional hiatus” before pursuing new opportunities outside of ImmunoGen. Berkenblit will leave at the end of August, and Michael Vasconcelles, M.D., ImmunoGen EVP of R&D and medical affairs, will take on the CMO role. Release > TheracosBio CEO Albert Collinson, Ph.D., is handing the reins over to newcomer Brian Connelly. The new leader has practiced law for over 15 years for a law firm supporting biotech and life science companies and also co-founded IncreVet, a veterinary drug development company acquired by Theracos—TheracosBio’s parent company—last year. Release > Incyte’s chief scientific officer Dashyant Dhanak, Ph.D., has left the pharma to pursue other opportunities. Dhanak has held the CSO position since 2018, overseeing more than 15 investigational new drug applications—or requests to bring a drug into the clinic—during that time. Release > Zentalis Pharmaceuticals is welcoming Kimberly Freeman on as chief strategy officer. Before Zentalis, Freeman was VP, U.S. head of DDR franchise, oncology at AstraZeneca and has previously held leadership roles at Adaptimmune, Boehringer Ingelheim and GSK. Release > Ambrx Biopharma has snagged Renu Vaish to serve as the company’s chief regulatory officer. She most recently was SVP of regulatory affairs for SpringWorks and has held leadership roles at Celgene, Merck & Co. and Kite Pharma. Release > Viral-disease-focused Bioxytran has tapped Leslie Ajayi, M.D., Ph.D., to serve in its newly created interim chief medical officer position as well as chief of the medical advisory board. Ajayi’s clinical research efforts have resulted in the creation of a number of technical reports for Big Pharmas like Merck & Co., Servier, Bristol Myers Squibb, Roche, Pfizer and GSK. Release > The National Pharmaceutical Council has added former Institute for Clinical and Economic Review executive Jonathan Campbell, Ph.D., as chief science officer to direct the group’s research portfolio. Release > Numerof & Associates has brought on former Bristol Myers Squibb, Amgen senior executive Michael Ryan as an executive adviser. He will help advise pharmaceutical clients at the healthcare strategy firm with strategy and planning, market access, policy analysis and other issues. Release > Former AdaptImmune executive Jeanette Evans will takeover as chief business officer of the Cell and Gene Therapy Catapult. The independent, U.K.-based organization works to advance cell and gene therapies through development. Release > Playground Global is bringing on a16z vet Nate Chang to expand its life science venture capital footprint. Chang spent nearly 15 years in healthcare investment banking before joining a16z in 2019. Release > Parisa Zamiri, M.D., is joining Complement Therapeutics as chief medical officer, jumping from Graybug Vision where she held the same role. Before Graybug, Zamiri was the ophthalmology therapeutic head at Novartis. Release > Numerous executive changes are afoot at Molecular Templates six weeks after another round of layoffs. Gabriela Gruia, M.D., has been named interim chief medical officer, Jason Kim will be president and chief financial officer, Kristen Quigly is the new chief operating officer and Grace Kim is now chief strategy officer and head of investor relations. Release