Author Interviews, CMAJ, Endocrinology, OBGYNE / 02.06.2020

MedicalResearch.com Interview with: Lois Donovan MD FRCPC Clinical Professor Cumming School of Medicine Division on Endocrinology and Metabolism and Department of Obstetrics and Gynecology University of Calgary MedicalResearch.com: What is the background for this study? 1) We observed in our clinical practices that minor TSH elevations in early pregnancy frequently normalized without intervention. 2) Recent randomized control trials have failed to show benefit of treating women with levothyroxine with minor TSH elevations in pregnancy  (more…)
Author Interviews, JAMA, OBGYNE, Pediatrics / 01.06.2020

MedicalResearch.com Interview with: Katri RäikkönenKatri Räikkönen Professor, Department of Psychology and Logopedics University of Helsinski MedicalResearch.com: What is the background for this study? Response: Maternal antenatal corticosteroid treatment is standard care when there is a risk for preterm delivery. The treatment improves the prognosis of babies born preterm. In high-income countries, antenatal corticosteroid treatment has been in routine use for over 30 years. Recommendations and clinical care guidelines for maternal antenatal corticosteroid treatment differ between continents and countries. In Finland the treatment is currently recommended when the risk for preterm delivery is at 34 gestational weeks or less. In select cases, the treatment is recommended even later in gestation. Corticosteroids accelerate fetal maturation, especially in the lungs, and increase the child’s resilience to the stress that results from being born preterm. However, antenatal corticosteroids not only cross the placenta, but also cross the the blood-brain barrier and may harm fetal brain development. We are not aware of previous population-based studies that would have tested if maternal antenatal corticosteroid treatment would be associated with mental and behavioral disorders in children and we are not either aware of studies that would have tested if any associations would be explained by shared genetic or familial factors. (more…)
Author Interviews, OBGYNE, Pediatrics / 21.05.2020

MedicalResearch.com Interview with: Yanmin Zhu, M.S., Ph.D. Postdoctoral Research Fellow Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women's Hospital and Harvard Medical School  MedicalResearch.com: What is the background for this study? Response: Animal studies and case reports suggest a potential teratogenic effect associated with the use of high doses of fluconazole during pregnancy. The malformations reported in case reports have a distinct phenotype, including femoral bowing, thin ribs, cleft palate, and abnormal craniofacial ossification. A few controlled studies have examined the risk of congenital malformations associated with the use of fluconazole during the first trimester, but findings are inconsistent. (more…)
Author Interviews, Infections, OBGYNE / 16.05.2020

MedicalResearch.com Interview with: SCYNEXIS IncMarco Taglietti, M.D. President and Chief Executive Officer SCYNEXIS Inc Dr. Taglietti discusses SCYNEXIS’ announcement of positive results from its second Phase 3 study investigating the safety and efficacy of oral ibrexafungerp as a treatment for vaginal yeast infection.  MedicalResearch.com: What is the background for this study? Response:  The VANISH-306 study is one of two Phase 3 randomized, double-blind, placebo-controlled, multi-center studies designed to demonstrate the superiority of oral ibrexafungerp to placebo as a treatment of vaginal yeast infections, also known as vulvovaginal candidiasis. Ibrexafungerp is a novel oral/intraveneous broad-spectrum antifungal in late stage development for multiple indications, from the treatment and prevention of vaginal yeast infections to life-threatening invasive fungal infections in the hospital setting. The VANISH-306 study was conducted in 42 centers in the US and EU and enrolled 449 patients. Patients were randomized to oral ibrexafungerp (two doses of 300mg taken 12 hours apart for one day) or placebo in a 2:1 ratio The primary endpoints included clinical cure rate, defined as the complete resolution of all signs and symptoms at the test-of-cure visit (Day-10) and secondary endpoints included mycological eradication and change in signs and symptoms scores compared to baseline at both day 10 and follow-up visit (Day-25). The VANISH-306 study reported positive topline data which showed that 63.3% of ibrexafungerp-treated patients saw a complete resolution of signs and symptoms 10 days following a single day dose of ibrexafungerp. The first study in the VANISH program was VANISH-303, a US-based study, had an identical design to the VANISH-306 study. The VANISH-303 study reported positive topline data in November 2019 which showed that 50.5% of ibrexafungerp-treated patients saw a complete resolution of signs and symptoms 10 days following a single day dose of ibrexafungerp. Both VANISH studies showed a highly significant statistical difference in the primary and secondary efficacy endpoints. The product was well tolerated. (more…)
Author Interviews, Infections, OBGYNE, Sexual Health, STD / 13.05.2020

MedicalResearch.com Interview with: Gregory Kaufman, M.D. Senior Vice President Global Clinical and Medical Affairs Specialty at Lupin MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by trichomoniasis?  How common is this infection? Response: The Phase 3 trial evaluated the effectiveness and safety of a single oral dose of Solosec® (secnidazole) 2g oral granules for the treatment of trichomoniasis in adult women. Top-line results were positive and showed that Solosec was generally well-tolerated. Trichomoniasis is the most common non-viral sexually transmitted infection (STI) in the U.S., and is caused by a protozoan parasite called Trichomonas vaginalis.[i] Trichomoniasis affects 3 to 5 million people in the U.S.,[ii] and is four- to five-times more prevalent in in women, compared to men.[iii]. (more…)
Author Interviews, Endocrinology, OBGYNE / 14.04.2020

MedicalResearch.com Interview with: “Open Space Yoga Hawaii” by Open Space Yoga Hawaii is licensed under CC BY 2.0Diana Speelman, Ph.D. Director of Research for the College of Medicine Associate Professor of Biochemistry Reproductive System Course Coordinator L|E|C|O|M Erie, PA 16509 MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by PCOS? Response: Polycystic ovary syndrome (PCOS) is the most common hormone disorder in women of reproductive age.  It is characterized by high androgen levels (e.g., testosterone) in the blood and irregular menstrual cycles.  Despite affecting 5-15% of women, its cause is unknown.  While medications can be used to reduce androgen levels, or help achieve menstrual regularity or stimulate ovulation, these often have undesirable side effects.  Our goal was to investigate the effectiveness of non-pharmacologic approaches, including yoga, on improving the characteristics associated with the disorder.  (more…)
Anesthesiology, Author Interviews, COVID -19 Coronavirus, OBGYNE / 13.04.2020

MedicalResearch.com Interview with: Dr. Alicia Warlick, MD Anesthesiologist at UNC/Rex, American Anesthesiology Raleigh, North Carolina MedicalResearch.com: As a physician working on the frontlines of the COVID-19 battle, how are you addressing expecting mothers’ concerns about the disease and how it might impact their pregnancy? Response: While COVID-19 has disrupted nearly every aspect of healthcare, whether its virtual appointments or delayed surgeries; there are certain things that are inevitable – like childbirth. As this virus continues to take over the country and we learn more about it each day, pregnant women are facing new challenges and fears. For women approaching their due dates, questions about staying healthy, keeping their baby safe and limiting their risk of exposure while in the hospital are all leading to anxiety and stress. And while policies and guidelines are constantly changing, as physicians we need to remind our patients that we are there to alleviate their concerns, address their questions and remind them to not lose sight of the joy the comes with bringing a child into the world. It’s a scary time for everyone, but by working together and supporting one another, we will get through this. (more…)
Author Interviews, Diabetes, Kidney Disease, OBGYNE, Race/Ethnic Diversity / 30.03.2020

MedicalResearch.com Interview with: Silvi Shah, MD, MS, FACP, FNKF, FASN Assistant Professor Division of Nephrology University of Cincinnati Cincinnati, OH-45267 MedicalResearch.com: What is the background for this study? Response: The study identified 42,190,790 pregnancy related hospitalizations between Jan. 1, 2006 and Dec. 31, 2015, using data from the from the Nationwide Inpatient Sample. (more…)
Author Interviews, Cancer Research, Columbia, OBGYNE / 11.03.2020

MedicalResearch.com Interview with: Matthew E. Spotnitz, MD, MPH Departments of Biomedical Informatics and Obstetrics and Gynecology Columbia University Medical Center Observational Health Data Sciences and Informatics, and Medical Informatics Services New York-Presbyterian Hospital, New York, New York MedicalResearch.com: What is the background for this study? Response: Our take home message is that copper and hormonal IUDs may have different physiological effects on the female genitourinary system. (more…)
Author Interviews, Fertility, Heart Disease, JAMA, OBGYNE / 27.02.2020

MedicalResearch.com Interview with: Shi Wu Wen PhD Senior Scientist, Clinical Epidemiology Program Professor, Department of Obstetrics & Gynecology University of Ottawa MedicalResearch.com: What is the background for this study? Response: Previous studies have shown that having a baby as a result of using assisted procedures such as IVF nearly doubles the chance that a baby will have heart problems. (more…)
Author Interviews, OBGYNE, Pediatrics / 04.02.2020

MedicalResearch.com Interview with: Andrea M. Tilstra Doctoral Candidate, Department of Sociology Population Program, Institute of Behavioral Science University of Colorado Boulder MedicalResearch.com: What is the background for this study? Response: Average U.S. birth weight declined across the 1990s and 2000s, and this has puzzled most researchers. We investigate this and find that the increases in cesarean deliveries and induction of labor between 1990 and 2013 resulted in a shift in the gestational age distribution of U.S. births. We find that births are less likely to occur at gestational weeks 40+ and much more likely to occur between weeks 37-39. Additionally, results from our simulations show that if U.S. rates of cesarean deliveries and labor induction had not increased over time, then average birth weight would have increased.   (more…)
Author Interviews, OBGYNE, Opiods, Pain Research / 28.01.2020

MedicalResearch.com Interview with: Dave Stack Chief Executive Officer and Chairman Pacira BioSciences  MedicalResearch.com: What is the background for this study? Response: Cesarean sections (C-sections) are one of the most common surgeries in the United States, and research shows many women experience moderate to severe pain after this procedure. When postsurgical pain is inadequately managed for new mothers, it can interfere with recovery, maternal-infant bonding and may even lead to postpartum depression. Additionally, prescribing data reveals that postsurgical opioid consumption poses a great risk to women. We recently completed a Phase 4 study of EXPAREL in C-section patients, and results revealed adding EXPAREL to bupivacaine transversus abdominis plane (TAP) blocks for C-section delivery provided significant reductions in opioids and pain scores. Results of that study provided the basis for the design of this next-generation study, which was created to be completely opioid-free in the EXPAREL arm. The study was a Phase 4 multicenter, active-controlled study conducted in 18 clinical sites in the United States, with 169 enrolled patients undergoing elective C-section. The enrolled C-section patients were randomized to receive either 150 mcg morphine spinal anesthesia plus a standard of care postoperative pain regimen, 50 mcg morphine spinal anesthesia plus EXPAREL TAP field block, or opioid-free spinal anesthesia plus EXPAREL TAP block. Patients in the EXPAREL arms received a protocol-defined non-opioid postsurgical pain management regimen including ketorolac, acetaminophen, and ibuprofen.  (more…)
Abbvie, Author Interviews, NEJM, OBGYNE / 23.01.2020

MedicalResearch.com Interview with: William D Schlaff  MD Chair, Department of Obstetrics & Gynecology Jefferson University MedicalResearch.com: What is the background for this study? Response: Symptomatic uterine fibroids are the most common indication for hysterectomy in the US.  Heavy bleeding is the most common and troublesome symptom.  The primary treatment for this problem is surgery—either hysterectomy or (less commonly) myomectomy.  Medical treatment which reduces the bleeding related to fibroids without surgery is a valuable treatment for many women.  Existing medications include, most commonly GnRH agonists.  These are injectable medications that are given every 1 or 3 months (depending on the formulation) and have been shown to reduce bleeding related to fibroids.  They work by initially stimulating the ovaries to increase estrogen levels for 10-14 days before suppressing estrogen and thereby reducing bleeding.  Even though the medication is given every 1 or 3 months, the effect of the medication can last quite a bit longer; in cases of adverse response, the medication cannot be immediately stopped.  The medication reported in this trial, Elagolix, is a GnRH antagonist given by mouth twice daily and resulting in suppression of estrogen secretion within a matter of hours.  The effect of this medication wears off much more rapidly than the depot formulations described and can be stopped in the uncommon cases of adverse side effects.  (more…)
Author Interviews, OBGYNE, Pain Research / 17.01.2020

MedicalResearch.com Interview with: Rafael Maldonado Lopez MD PhD Full professor Departament de Ciències Experimentals i de la Salut Universitat Pompeu Fabra Barcelona MedicalResearch.com: What is the background for this study? Response: Endometriosis is a common, chronic and painful disease caused when the endometrium grows outside of the uterine cavity. These growths mainly affect organs in the pelvis causing pain and infertility, symptoms that are often accompanied with anxiety, depression, loss of working ability, and a substantial impact on quality of life. Current treatments include hormonal therapy and surgery, but the effectiveness of these treatments is rather limited, often have important unwanted side effects, and patients usually rely on self-management strategies. Therefore, there is an urgent need for researching new possible therapeutic approaches.  (more…)
Author Interviews, OBGYNE, Race/Ethnic Diversity / 16.01.2020

MedicalResearch.com Interview with: Elizabeth A. Howell, MD, MPP Director of The Blavatnik Family Women’s Health Research Institute Mount Sinai Health System Vice Chair for Research Professor in the Department of Obstetrics, Gynecology, and Reproductive Science Associate Dean for Academic Development Professor Department of Population Health Science and Policy Icahn Mount Sinai, New York MedicalResearch.com: What is the background for this study? Response: Previous research has demonstrated racial and ethnic disparities in severe maternal morbidity rates in hospitals and that between-hospital differences -- i.e., Black and Latina mothers receiving care at hospitals with worse outcomes -- explain a sizable portion of these disparities.  However, less attention has been paid to within-hospital disparities -- whether Black and Latina mothers have worse outcomes than White mothers who deliver in the SAME hospital. In this paper, we set out to measure within-hospital racial and ethnic disparities and to evaluate the potential contribution of insurance type to these disparities.  Our study question was based on the observation that women with Medicaid can follow different care pathways than women with private insurance. Pregnant women insured by Medicaid are often seen by resident physicians with attending coverage that may differ from attending physicians caring for commercially insured women. In addition, Medicaid reimbursement for delivery hospitalization is far less than that for commercially insured.  (more…)
Author Interviews, Dermatology, HPV, Infections, JAMA, OBGYNE / 08.01.2020

MedicalResearch.com Interview with: Niklas Worm Andersson, MD Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen NV, Denmark MedicalResearch.com: What is the background for this study? What is Podophyllotoxin used for? Response: Podophyllotoxin is an antimitotic agent primarily used in the local treatment of anogenital warts, which are among the most prevalent sexually transmitted diseases worldwide. Most women affected by anogenital warts are of childbearing age and during pregnancy, they may become symptomatic, enlarge, or multiply. While podophyllotoxin is part of first-line treatment of anogenital warts for the non-pregnant population, it is contraindicated during pregnancy. Fetal safety data are limited and to our knowledge, no previous human data exist to help inform on this issue. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, OBGYNE, Pediatrics, Weight Research / 02.01.2020

MedicalResearch.com Interview with: Elvira Isganaitis, M.D., M.P.H. Pediatric Endocrinologist, Joslin Diabetes Center Assistant Professor of Pediatrics, Harvard Medical School Boston, MA 02215 MedicalResearch.com: What is the background for this study? Response: The concept that a mother's nutrition prior to and during pregnancy is important for health outcomes in the offspring is now well accepted. For example, women intending to get pregnant must take prenatal vitamins, and are encouraged to attain a healthy weight before conception. However, much less is known about how a father's nutritional status may influence childhood health outcomes.  Based on studies in animals, exposure to undernutrition, high-fat diet, or stressful experiences in fathers can result in increased risk of obesity and diabetes in the offspring. These effects are mediated in part by epigenetic mechanisms (i.e. changes in gene expression due to differences in DNA methylation, histones, or other non-genetic mechanisms). (more…)
Author Interviews, Cancer Research, Fertility, OBGYNE / 11.12.2019

MedicalResearch.com Interview with: Marie Hargreave, PhD Senior Researcher Danish Cancer Society Research Center Copenhagen MedicalResearch.com: What is the background for this study? Response: Very few studies have examined the association between frozen embryo transfer and the risk of childhood cancer and most of them have been too small to show any effects. In our large nationwide population based study we found that frozen embryo replacement was associated with an increased risk of childhood cancer and especially for leukemia and neuroblastomas. (more…)
Author Interviews, OBGYNE, Opiods / 05.12.2019

MedicalResearch.com Interview with: Dr. Rupa Radhakrishnan, MD Assistant professor of Radiology and Imaging Sciences Indiana University School of Medicine MedicalResearch.com: What is the background for this study? Response: Opioid use in pregnancy is a major public health crisis. Opioids adversely impact maternal, fetal and infant health. Infants who were exposed to opioids in the womb, can have withdrawal symptoms soon after birth, and are also at risk for poor long term neurodevelopment outcomes. Our group studied the changes in brain function in infants exposed to opioids in the womb, to understand how opioids affect the developing brain. We used resting state functional MRI to study these infants.  (more…)
Author Interviews, Infections, OBGYNE / 04.12.2019

MedicalResearch.com Interview with: Giovanni Piedimonte, MD, FAAP, FCCP Vice President for Research Institutional Official Professor of Pediatrics Tulane University MedicalResearch.com: What is the background for this study? Response: We have been testing the hypothesis that, when a pregnant woman catches a common cold with a virus called respiratory syncytial virus (RSV), viral particles can spread from the mother’s respiratory tract to the unborn child via the placenta. Preliminary data in animal models suggest that this is possible, and might cause changes in lung growth predisposing the offspring to develop asthma after birth. Recently, also human data have supported this theory. However, an essential step to conclusively demonstrate vertical transmission of respiratory viruses was the confirmation that human placentas can be infected and allow the transmission of such germs, which is the main finding of this study. (more…)
Author Interviews, Gender Differences, OBGYNE / 03.12.2019

MedicalResearch.com Interview with: Dr. Amanda N. Sferruzzi-Perri University Lecturer in Physiology Royal Society Dorothy Hodgkin Research Fellow & Lister Institute Fellow University of Cambridge MedicalResearch.com: What is the background for this study? Response: Having a pregnancy in advanced age (35 years or older) is often associated with a series of risks and complications for both the mother and her baby. These include preeclampsia (raised blood pressure in the mother during pregnancy), gestational diabetes (diabetes in the mother that develops onset in pregnancy), stillbirth and fetal growth restriction. There is also evidence from work in experimental animals that offspring from mothers who have entered pregnancy at an older age, are at heightened risk of heart problems and high blood pressure as young adults and particularly so, if they are male rather than female. We wondered whether these sex-related differences may derive from the way in which the male and female fetuses were supported within the womb, in an aged mother during pregnancy. (more…)
Author Interviews, OBGYNE / 19.11.2019

MedicalResearch.com Interview with: Cynthia Gyamfi-Bannerman, MD, MSc Vice Chair for Faculty Development Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Director, Maternal-Fetal Medicine Fellowship Program Co-Director, CUMC Preterm Birth Prevention Center  MedicalResearch.com: What is the background for this study? Response: ​Delayed cord clamping (DCC) at delivery has been associated with neonatal benefit.  Specially, it decreases the likelihood of anemia.  It became widely recommended as a practice for all deliveries even though the literature showing benefit to the neonates was largely only for low risk women with vaginal deliveries.  In theory, DCC could result in increased blood loss during a cesarean due to the blood loss encountered when cutting into a gravid uterus. (more…)
Author Interviews, Cancer Research, HPV, JAMA, OBGYNE / 07.11.2019

MedicalResearch.com Interview with: Rachel L. Winer, PhD Professor Department of Epidemiology School of Public Health HPV Research Group University of Washington Seattle, WARachel L. Winer, PhD Professor Department of Epidemiology School of Public Health HPV Research Group University of Washington Seattle, WA  MedicalResearch.com: What is the background for this study? Response: In the U.S., 25% of women do not receive recommended cervical cancer screening. Increasing screening participation is a high priority, because over half of the 12,000 cervical cancers diagnosed each year in the U.S. are in women who are underscreened. Currently available options for cervical cancer screening in the U.S. include Pap testing or HPV testing, either alone or in combination. HPV self-sampling is an emerging option for screening because HPV tests – unlike Pap tests – can be performed on either clinician- or self-collected samples, with similar accuracy. Internationally, several countries (including Australia and the Netherlands) include HPV self-sampling as a cervical cancer screening option for underscreened women.  (more…)
Author Interviews, Cognitive Issues, Environmental Risks, OBGYNE, Pediatrics / 24.10.2019

MedicalResearch.com Interview with: Eva Tanner, PhD, MPH, Postdoctoral Researcher Department of Environmental Medicine and Public Health Icahn School of Medicine at Mount Sinai Carl-Gustaf Bornehag, PhD Professor at Karlstad University MedicalResearch.com: What is the background for this study? Response: Most prior research on health risks from chemical exposure study one chemical at a time. However, we are exposed to a multitude of chemicals every day in the air we breathe, food and water we consume, and things we touch. This is supported by global biomonitoring data showing that humans in general have a high number of chemicals identified in their bodies, i.e., in blood, urine, breast milk, saliva, etc. Unfortunately, we don’t know how such single chemicals act in complicated mixtures and impact our health, or the health of future generations. We conducted this study to help understand how prenatal exposure to mixtures of proven or suspected endocrine disrupting chemicals - found in common consumer products - during the earliest part of life may impact a child’s brain development and cognition in school age. (more…)
Author Interviews, Blood Pressure - Hypertension, Diabetes, JAMA, OBGYNE / 18.10.2019

MedicalResearch.com Interview with: Haitham M. Ahmed, MD, MPH Chair of Cardiology, Advantage Care Physicians Brooklyn, New York MedicalResearch.com: What is the background for this study? Response: This was a meta-analysis of more than a quarter m illion mothers looking at the long-term cardiovascular risk reduction of mothers who breastfed their babies.  (more…)
Author Interviews, Kidney Disease, OBGYNE / 02.10.2019

MedicalResearch.com Interview with: Silvi Shah, MD, MS, FACP, FASN| Assistant Professor Division of Nephrology, University of Cincinnati Cincinnati, OH-45267 MedicalResearch.com: What is the background for this study? Response: Our study uses data from the largest retrospective cohort of dialysis patients in the United States from the United States Renal Data System to determine pregnancy rates and factors associated with pregnancy in 47,555 women aged 15-44 years on dialysis. We identified 2,352 pregnancies with a rate of 17.8 pregnancies per 1000 person-years (PTPY) with the highest rate in women aged 20-24 years (40.9 PTPY). (more…)
Author Interviews, Infections, JAMA, OBGYNE, USPSTF / 01.10.2019

MedicalResearch.com Interview with: Melissa A. Simon, M.D., M.P.H. Member, U.S. Preventive Services Task Force George H. Gardner professor of clinical gynecology, Vice chair of clinical research Department of Obstetrics and Gynecology Professor of preventive medicine and medical social sciences Northwestern University Feinberg School of Medicine  MedicalResearch.com: What is the background for this study? Response: Asymptomatic bacteriuria, or ASB, is when someone has bacteria in their urine but does not have any signs or symptoms of a urinary tract infection. For pregnant people, this can be a major health concern resulting in severe, even life-threatening, infections that can lead to serious harms for both the mother and the baby. The Task Force’s primary finding in updating its recommendation on this topic was that screening for ASB continues to be beneficial in preventing complications and preserving the health of mothers and their babies during pregnancy.  (more…)
ADHD, Author Interviews, Autism, JAMA, OBGYNE / 30.08.2019

MedicalResearch.com Interview with: Tianyang Zhang, MSc Centre for Psychiatry Research, Department of Clinical Neuroscience Stockholm Health Care Services, Stockholm County Council Department of Medical Epidemiology and Biostatistics Karolinska Institutet Stockholm, Sweden MedicalResearch.com: What is the background for this study? Response: We know that births by caesarean delivery are linked to several negative health outcomes in the children, such as obesity, asthma, allergy, and type 1 diabetes. However, the association between c-section and neurodevelopmental and psychiatric disorders has been less studied. In addition, it is unclear whether the extent of this association is different if a caesarean section is performed planned in advance or urgently due to medical reasons during a delivery. (more…)
Author Interviews, Cancer Research, HPV, OBGYNE / 15.08.2019

MedicalResearch.com Interview with: Marc Eloit, D.V.M, Ph.D. Pathogen Discovery Laboratory, Biology of Infection Unit, Institut Pasteur Paris, France MedicalResearch.com: What is the background for this study? Response: Human papillomaviruses (HPV) are responsible for >99% of cervical cancers. Currently, cervical cancer screening either focuses on testing for the presence of HPV or identifying abnormal cervical cells with cytology (Pap test). However, molecular diagnostic tests based on the detection of viral DNA or RNA have low positive predictive values for the identification of cancer or precancerous lesions, and analysis of cervical cells with the Pap test, even when combined with molecular detection of high-risk HPV, results in a significant number of unnecessary colposcopies. We have developed HPV RNA-Seq, a new “two-for-one” molecular diagnostic test that not only detects the type of HPV, but also identifies precancerous markers. This test is therefore designed to diagnose the riskiest forms of HPV infection, provide rapid results at moderate cost, and helps avoiding unnecessary diagnostic procedures. HPV RNA-Seq is based on the dual combination of multiplexed reverse transcription PCR (RT-PCR) and next-generation sequencing (NGS). RT-PCR is a sensitive way to detect small amounts of RNA, the genetic material that reflects the activity of the HPV genes, and NGS finely characterizes the amplified viral sequences. This enables detection of up to 16 high-risk or putative high-risk HPV in a sample as well as the presence of precancerous markers. (more…)