Bio-Reference Laboratories Inc announced that it and Natera have entered into a definitive agreement to commercialize the Panorama non-invasive prenatal screening test developed by Natera. The Panorama test will be sold by the GenPath business unit of Bioreference.
Panorama is a blood test that uses 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 as early as the ninth week of pregnancy.
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 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 NATUS [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.