An expanded carrier screening
test provides an opportunity to look beyond a patient's family history or ethnic predispositions to particular diseases, which is increasingly valuable as the obstetrics and gynecology (OB/GYN) physician community incorporates broader screening into its routine standard of care.
Physicians seeing patients for preconception or prenatal counseling should now be advising them about cystic fibrosis carrier screening
, according to the American College of Obstetricians and Gynecologists.
The Foundation plans to accomplish its mission of eradicating Batten disease in two ways: first, by raising awareness and money to accelerate research to find a cure; and second, by preventing Batten disease and hundreds of other rare genetic conditions through the development of a carrier screening
The FDA approval letter noted that: "Along with this authorization, the FDA is also classifying carrier screening
tests as class II.
CHICAGO -- The American College of Obstetricians and Gynecologists is preparing to announce recommendations that are expected to widen the scope of who should be offered carrier screening
for cystic fibrosis, Dr.
9%) test that provides superior mutation coverage for carrier screening
in adults and as an aid to diagnosis in newborns.
In addition to the authorization to market the Bloom Syndrome Carrier Status test report, the FDA is also classifying autosomal recessive carrier screening
tests as class II with the intention to exempt such carrier tests from FDA premarket review.
The InPlex[TM] CF Molecular Test is a genotyping test that provides information for cystic fibrosis carrier screening
for adults of reproductive age as recommended by the American College of Medical Genetics (ACMG) and the 2005 American College of Obstetrics and Gynecology (ACOG)2, as an aid in newborn screening for cystic fibrosis, and in confirmatory diagnostic testing for cystic fibrosis in newborns and children.
5, 2015 /PRNewswire-USNewswire/ -- Carrier screening
for inherited genetic disorders is an important part of preconception and prenatal care for the nearly 4 million women who give birth in the US annually.
Nanogen's NanoChip([R]) multiplexing platform was recently submitted for FDA 510(K) clearance, along with the company's cystic fibrosis carrier screening
The National Institute of Health (NIH), the American College of Medical Genetics (ACMG), and the American College of Obstetricians and Gynecologists (ACOG) recommends offering CF carrier screening
to all pregnant women and for preconception evaluation.
Similar Carrier Screening
for Tay-Sachs Decreased Incidence of Disease by over 90%