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.