Importance of increased funding for molecular diagnostics

On July 9, 2009, the Society for Women’s Health Research convened experts on Capitol Hill to educate lawmakers on the importance of increased funding for new medical tests, called molecular diagnostics.

Molecular diagnostics test a patient for particular genetic markers. “These markers are used to determine the patient’s potential benefit from a specific therapy, or risk of developing a specific disease,” according to Ester Stein, reimbursement manager for global healthcare policy at Abbot Healthcare. “The results of these tests are leading to more personalized and specific medicine.”

Cancer diagnostics are the fastest growing field in molecular diagnostics. An example of this is a test that will determine if a breast cancer patient will benefit from a specific chemotherapy drug. The test costs approximately $500, but that seems a small price to pay to know if a woman would or would not benefit from a treatment that will cost $25,000 - $80,000. “It’s about getting the right woman on the right therapy,” said Stein.

Molecular diagnostics have the potential to transform healthcare by providing targeted medicine to patients. Stein is hopeful that each drug will have a diagnostic test associated with it in the next 10-20 years. “This will save time, money, and treatment risks if the drug isn’t right for the patient,” she said.

Jeanne Jordan, Ph.D., professor at the School of Public Health and Health Services at the George Washington University, spoke about a specific molecular diagnostic to treat expectant mothers with perinatal group-B streptococcal (GBS) disease in order to prevent transmission to their infants.

GBS is a common bacteria that lives in our digestive tracts and usually causes no harm to an adult. According to the Society for Women’s Health Research, GBS can also reside in a woman’s genital tract. GBS becomes harmful when it is passed from a mother to an infant during childbirth. Infants infected with GBS may develop meningitis, or pneumonia.

“Group-B strep is a leading cause of neonatal morbidity and mortality in the United States,” Jordan said. “The good news is that GBS is preventable with antibiotics. The expectant mother must receive two to four hours of antibiotic treatment while in labor to significantly reduce GBS transmission to newborns during delivery.”

There is already a diagnostic test in place to detect if an expectant mother carries GBS that is normally administered three five weeks before delivery, but it takes three days to get a result. There are many scenarios in which this three-day time frame is just not fast enough; a woman may go into labor before learning her GBS status, or a woman may have to deliver her baby in a hospital that doesn’t have access to her medical records.

There is now a rapid response diagnostic test that can detect GBS status in less than two hours. This test is not administered in all hospitals, however, due to the need for trained laboratory technicians who can perform this test working 24-hours a day.

Shiraz Sunderji, M.D., professor of obstetrics and gynecology at the University of Toledo, and director of graduate medical education in obstetrics and gynecology at The Toledo Hospital in Toledo, Ohio, spoke about preeclampsia, a condition that affects five percent of pregnancies in the United States

Preeclampsia is a condition that occurs during pregnancy and the postpartum period; characterized by the onset of protein in the urine and hypertension after twenty weeks of pregnancy. The cause of preeclampsia remains unknown, so there is no way to prevent the condition. The only way to “cure” a woman of preeclampsia is to deliver her baby.

“The risks of preeclampsia to the mother are seizers, [kidney] and liver failure, stroke and even death,” Sunderji said. “The risks to the fetus are growth restrictions, a lack of oxygen which results in disability, prematurity and death.”

Sunderji said there is no clinically useful screening test for preeclampsia, but there are two molecular diagnostic tools being developed that can predict if a woman is destined to develop the condition. If a woman is determined to be a candidate to develop preeclampsia, she can begin seeing a high-risk obstetrician right away.

“It is important to recognize that research and innovation in diagnostic tools and techniques are critical to health care outcomes,” said Phyllis Greenberger, M.S.W., president and CEO of the Society for Women’s Health Research. “Being able to diagnose potential health problems early and accurately are essential for successful prevention strategies and appropriate treatment.”

http://www.preeclampsia.org/