Bio-Reference Laboratories, Inc. (BRLI) announced today that the Company and Natera have entered into a definitive agreement to commercialize the Panorama(TM) non-invasive prenatal screening test developed by Natera. The Panorama test will be sold by the GenPath business unit of Bioreference.
Panorama is a simple blood test that uses cutting-edge genotyping and sequencing technologies to identify chromosomal aneuploidies such as trisomies 13, 18, 21, and certain sex-chromosome abnormalities. According to the proceedings of the recent Society of Maternal Fetal Medicine conference held in San Francisco, non-invasive prenatal tests (NIPT) can reduce fetal loss by up to 91% while detecting the same amount of aneuploidies 13, 18, 21 by avoiding invasive Amniocentesis and chorionic villi sampling procedures. Panorama can be used starting 9th week of pregnancy.
Marc D. Grodman, MD, CEO of BRLI, commented: "With the recent guidelines published on non-invasive prenatal screening by ACOG, it is clear that this is a beneficial service to women and their clinicians while facing high-risk pregnancies. We are pleased to be able to offer Panorama as part of our full-service prenatal offering."
Added Matthew Rabinowitz, Ph.D., chief executive officer of Natera, "Our sophisticated technology has demonstrated that Panorama is clearly best in class, with a sensitivity and specificity unparalleled by others, and by combining forces with GenPath we are able to provide access to the test to the broadest patient population possible. In addition, the test is offered with a generous patient assistance program that enables Panorama to be available to all pregnant women, regardless of income level."
In clinical validation studies, Panorama demonstrated a sensitivity of greater than 99% when detecting common chromosomal abnormalities such as trisomy 21, trisomy 18 and trisomy 13; and 92% when detecting monosomy X. In addition, Panorama demonstrated a specificity of 100% with no false positives for all the syndromes tested. The test uses fetal cell-free DNA found in maternal blood and works as early as nine weeks gestation. Panorama's clinical validation data was presented live at the annual Society of Maternal Fetal Medicine Meeting on Feb. 15, 2013.
Panorama's technology analyzes, in a single reaction, 19,500 single nucleotide polymorphisms (SNPs), which are the most informative portions of an individual's DNA. It utilizes the Next-generation Aneuploidy Testing Using SNPs algorithm, an advanced version of Natera's proprietary informatics. Panorama has been validated globally and is currently being evaluated in several other clinical trials for the detection of genetic disorders, including trisomy 21, trisomy 18, trisomy 13, monosomy X, XXY, XYY, XXX and triploidy. The test uses a simple blood draw from the mother and can be performed within the first trimester of pregnancy, as early as 9 weeks, without any risk to the fetus.
Natera is a genetic testing company that has developed a proprietary bioinformatics-based technology 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 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.
About Bio-Reference Laboratories, Inc.
BRLI is a clinical testing laboratory offering testing, information and related services to physician offices, clinics, hospitals, employers and governmental units. We believe that we are the fourth largest full-service laboratory in the United States and the largest independent regional laboratory in the Northeastern market. BRLI offers a comprehensive list of laboratory testing services utilized by healthcare providers in the detection, diagnosis, evaluation, monitoring and treatment of diseases. BRLI primarily focuses on esoteric testing, molecular diagnostics, anatomical pathology, women's health and correctional health care.
Tara Mackay, Investor Relations
(201) 791-1941 (fax)