MedGenome Inks Licensing Agreement with Natera to Perform Panorama™ Non-Invasive Prenatal Test (NIPT) in India

MedGenome will be the first molecular diagnostic lab to establish Non-Invasive Prenatal Testing (NIPT) for chromosomal disease in a facility in India

Bangalore, Jan 12, 2015: MEDGENOME, a leader in clinical genomic testing and a provider ofgenomic solutions for personalized healthcare in India, and NATERA, a global leader in non-invasive genetic testing, have entered into an exclusive agreement to bring non-invasive prenatal testing (NIPT) to India.As part of the agreement, MedGenome will have exclusive license to develop the capacity and perform the Panorama test in India.

Natera’s test, known as PANORAMA™,is a non-invasive prenatal screening test that examines fetal DNAin the mother’s blood to assesswhether a developing baby is at high risk for having an abnormality in the chromosomes. Panorama uses a simple blood draw from the mother to screen for trisomy 21 (Down’s syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) and select sex chromosome abnormalities, such as monosomy X (Turner syndrome).
Panorama is the only screening test in the world that detects triploidy status in the fetus (69 chromosomes rather than 46 chromosomes), and reports whether a “vanishing” twin was present, i.e. there was a twin but it got absorbed, and is no longer detectable by ultrasound. Panorama can be performed from as early as 9 weeks gestation. In contrast to traditional prenatal genetic testing like chorionic villus sampling and amniocentesis, which are invasive tests, Panorama does not pose any risk for the fetus.

NOTE: IN ACCORDANCE WITH INDIAN LAW, PANORAMAWILL NOT BE USED TO REVEAL THE SEX OF THE FETUS.

On this occasion, MR. SAM SANTHOSH, CEO, MEDGENOME spoke about the partnership with Natera, “_As per estimates, chromosomal abnormalities occur in about 1 of 200 live births. Infants with these abnormalities have mental retardation and suffer from malformations and disabilities. Due to the large number of births (26 million per year), India has the largest number of babies born with chromosomal disorders in the world (almost 130,000 per year). MedGenome is happy
to partner with Natera and launch Panorama, a superior second-generation non-invasive prenatal test, compared to its peers. Through our partnership with Natera, we hope to bring about significant changes in the way pregnancies are managed in India.”

SOLOMON MOSHKEVICH, VICE PRESIDENT, MARKETING & BUSINESS DEVELOPMENT,NATERA said,“_Natera is committed to sharing its unique and proprietary technologieswith laboratories worldwidewho share our philosophy of clinical leadership and quality control. We are pleased to partner with MedGenome to bring Panorama to India.”

Another first from MedGenome is to carry out a research study involving 1000 women at high risk for chromosomal disease in the fetus, in whom NIPT will be provided _free of charge, _starting from 11 to 20 weeks of pregnancy. Prominentfetal medicine specialists and obstetricians from all over India will be involved. Dr. IC Verma, Director, Center of Medical Genetics, Sir Ganga Ram Hospital, and renowned clinical geneticist, will be leading this study. The study will help in framing guidelines for use of NIPT in India, and check on ethnicity-related factors influencing the fetal fractions in the maternal plasma samples. Doctors will be given training to provide information regarding pre-test and post-test counselling, as part of the study.

Panorama is unique in analyzing Single-Nucleotide Polymorphisms (SNPs) to screen for chromosomal disorders in the fetus, making it the only test that can distinguish qualitatively between fetal and maternal DNA. This allows it to calculate the fetal fraction in its test results, i.e. the amount of fetal DNA in the maternal blood, and to avoid certain errors that may occur due to insufficient levels of fetal DNA in the maternal blood. This second-generation method produces highly accurate risk results, with significantly fewer falsepositives than other non-invasive tests. Panorama is expected to significantly improve the management of high risk pregnancies in India. CCI Newswire