Quest Diagnostics (NYSE: DGX), the world's leading diagnostic information services company, and Natera, a leading innovator in prenatal genetic testing, today announced that Quest Diagnostics will offer physicians access to PanoramaT, a new non-invasive prenatal test developed by Natera.
Panorama uses cell-free fetal DNA in circulating maternal blood to screen for chromosomal abnormalities associated with trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) and monosomy X (Turner syndrome). Panorama can be used as early as the ninth week of pregnancy.
Physician clients of Quest Diagnostics will be able to forward specimens for testing to Natera's CLIA-certified laboratory in San Carlos, Calif., which developed and validated the lab-developed Panorama test. The test will be made available to physician clients of Quest Diagnostics in certain regions in March and nationwide in the United States in April 2013. Additional terms were not disclosed.
"Cell-free fetal DNA testing is a significant advance in prenatal screening," said Charles Strom, M.D., Ph.D., senior medical director, genetics, Quest Diagnostics Nichols Institute. "By offering physicians and women access to Panorama, Quest Diagnostics is delivering on its commitment to provide clinically important innovations aligned with guideline-based care." Panorama is a non-invasive screening test that provides early information for assessing pregnancy risks. A 'low risk' Panorama test result indicates a lower likelihood that a pregnancy is affected. With this information, a woman may consider, in consultation with her physician and results of other medical assessments, whether to pursue or forgo invasive diagnostic testing, which carries a slight risk of miscarriage. A 'low risk' Panorama result does not guarantee an unaffected pregnancy.
In December 2012, the American Congress of Obstetricians and Gynecologists (ACOG) issued a medical opinion stating that cell-free fetal DNA testing is one option that can be used as a primary screening test in women at increased risk of aneuploidy. It may also be offered as a follow-up test for women with a positive first-trimester or second-trimester screening test result. Risk factors include advanced maternal age (35 years or older), a maternal serum screen indicating high risk, ultrasound abnormality and/or a history of prior pregnancy with a trisomy. ACOG also recommends physicians counsel patients on the limitations of these tests, including inability to confirm a pregnancy is not affected.
"Our Panorama test uses advanced SNP-based technology to provide physicians and expecting mothers with safe, reliable screening information, early in the pregnancy," said Matthew Rabinowitz, Ph.D., chief executive officer of Natera. "The broad availability of the test through Quest Diagnostics, a leader in women's health diagnostics, will help many more women and parents access DNA-based non-invasive prenatal screening." Quest Diagnostics Women's Health Services Quest Diagnostics is provider of comprehensive diagnostic information services for women's health disorders across the continuum of a woman's life. The company's specialized services feature one of the broadest menus of genetic services for pregnancy, including carrier screening for spinal muscular atrophy, cystic fibrosis and fragile X syndrome. The company also provides diagnostic information services for cervical, breast and ovarian cancer, and sexually transmitted diseases and reproductive tract infections. In addition, Quest Diagnostics provides genetic counseling services for clinicians and parents and publishes original research on women's health issues in peer-reviewed journals and at scientific conferences.
About Quest Diagnostics
Quest Diagnostics is the world's leading provider of diagnostic information services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic information services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at QuestDiagnostics.com. Follow us at Facebook.com/QuestDiagnostics and Twitter.com/QuestDX.
Natera is a leading genetic testing company that has developed a proprietary bioinformatics-based technology (NATUS) to deliver accurate and comprehensive high-throughput testing for reproductive indications from tiny quantities of DNA. Natera operates a CLIA-certified laboratory in San Carlos, Calif., providing a host of preconception and prenatal genetic testing services. Test offerings include pre-implantation genetic diagnosis to identify chromosomal anomalies or inherited genetic conditions in embryos generated during an IVF cycle; products-of-conception testing following miscarriage to rapidly and extensively analyze fetal chromosomes in order to understand the cause of the pregnancy loss; non-invasive prenatal testing to determine paternity; carrier screening tests to detect whether parents carry genetic variations that may result in disease in the child; and Panorama, a safe, simple test for pregnant women that identifies the most common chromosomal anomalies in a fetus as early as 9 weeks. Natera's PreNATUS clinical trial for non-invasive screening of fetal chromosomal anomalies is funded by the NIH and is being conducted by the leaders in maternal-fetal medicine in the United States. For more information, visit www.natera.com.