Washington, DC -- The clinical value of genetic tests that promise to identify your personal risk of developing cancer, diabetes, heart disease, Alzheimer’s, and a host of other diseases is unproven and these tests should not be used outside of clinical trials, says The American College of Obstetricians and Gynecologists (The College). Although genetic profile tests may prove to be important tools in the future, they are not ready for prime time.
Genetic technologies have advanced quickly since the human genome was sequenced in 2001. Scientists have identified hundreds of genetic variations that are associated with a variety of complex diseases such as cancer and Alzheimer’s. However, the majority of these variations are associated with a relatively small underlying risk of disease, and very few of them have undergone rigorous scientific study to determine if they have any clinical usefulness for patients.
Although emerging genetic technologies hold promise, The College’s position is that personalized genomic tests should be viewed as investigational. When a patient presents with the results of a personalized genomic test, physicians should refer her to a medical professional skilled in risk assessment and interpretation of the test results. Additionally, due to the limited knowledge of available genetic tests among patients and health care providers, difficulty in interpreting test results, lack of federal oversight of companies selling these tests, and concerns about privacy and confidentiality, The College reiterates its previous position that discourages direct-to-consumer and home genetic tests due to the potential harm of misinterpreted or inaccurate results.
Committee Opinion #527 “Personalized Genomic Testing for Disease Risk” is published in the June issue of Obstetrics & Gynecology.
Other recommendations issued in this month’s Obstetrics & Gynecology:
Committee Opinion #528 “Adoption” (Revised)
ABSTRACT: Obstetrician-gynecologists may find themselves at the center of adoption issues because of their expertise in the assessment and management of infertility, pregnancy, and childbirth. The lack of clarity about both ethical issues and legal consequences may create challenges for physicians. Therefore, the Committee on Ethics of the American College of Obstetricians and Gynecologists discusses ethical issues, proposes safeguards, and makes recommendations regarding the role of the physician in adoption.
Practice Bulletin #127 “Management of Preterm Labor” (Revised)
ABSTRACT: Preterm birth is the leading cause of neonatal mortality and the most common reason for antenatal hospitalization. In the United States, approximately 12% of all live births occur before term, and preterm labor preceded approximately 50% of these preterm births. Although the causes of preterm labor are not well understood, the burden of preterm births is clear—preterm births account for approximately 70% of neonatal deaths and 36% of infant deaths as well as 25–50% of cases of long-term neurologic impairment in children. A 2006 report from the Institute of Medicine estimated the annual cost of preterm birth in the United States to be $26.2 billion or more than $51,000 per premature infant. However, identifying women who will give birth preterm is an inexact process. The purpose of this document is to present the various methods proposed to manage preterm labor and to review the evidence for the roles of these methods in clinical practice. Identification and management of risk factors for preterm labor are not addressed in this document.
Technology Assessment #8 “Sonohysterography” (Revised)
ABSTRACT: The primary goal of sonohysterography is to visualize the endometrial cavity in more detail than is possible with routine transvaginal ultrasonography. The procedure consists of the transcervical injection of sterile fluid under real-time ultrasound imaging. The indications for sonohysterography include, but are not limited to, the evaluation of abnormal uterine bleeding; uterine cavity, especially with regard to uterine leiomyomas, polyps, and synechiae; abnormalities detected on transvaginal ultrasonography, including focal or diffuse endometrial or intracavitary abnormalities; congenital abnormalities of the uterus; infertility; and recurrent pregnancy loss. The procedure should not be performed in a woman who is pregnant or who could be pregnant or who has an existing pelvic infection or unexplained pelvic tenderness. Physicians who perform or supervise diagnostic sonohysterography should be skilled in vaginal ultrasonography and transcervical placement of catheters; should have training, experience, and demonstrated competence in gynecologic ultrasonography and sonohysterography; and should keep careful records. Portions of this document were developed jointly with the American College of Radiology, the American Institute of Ultrasound in Medicine, and the Society of Radiologists in Ultrasound.
The American College of Obstetricians and Gynecologists (The College), a 501(c)(3) organization, is the nation’s leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of approximately 56,000 members, The College strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women’s health care. The American Congress of Obstetricians and Gynecologists (ACOG), a 501(c)(6) organization, is its companion organization. www.acog.org