MedGenome, engaged in clinical genomic testing, is in the process of carrying out a human study involving 1000 women at high risk for chromosomal disease in the foetus. The company is keen to ensure that with the data coming out of the study, it would help the Union government to frame guidelines on Non Invasive Pre-Natal Test (NIPT) in India.
The company will be using its recently introduced Panorama, an NIPT that examines foetal DNA in the mother’s blood to assess whether a developing baby is at high risk for having an abnormality in the chromosomes.
The clinical trial on the women whom NIPT will be provided free of charge will start from 11 to 20 weeks of pregnancy. Leading fetal medicine specialists and obstetricians from all over India will be involved. Dr. IC Verma, Director, Center of Medical Genetics, Sir Ganga Ram Hospital, will be the principal investigator of this study. The data will also provide a guidance on ethnicity-related factors influencing the foetal 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, Sam Santhosh, CEO, MedGenome said in an email interaction.
Panorama is distinctive in analysing Single-Nucleotide Polymorphisms (SNPs) to screen for chromosomal disorders in the foetus, making it the only test that can differentiate qualitatively between foetal and maternal DNA. It would help calculate the fetal fraction in its test results, providing information on the amount of foetal DNA is present in the maternal blood and to prevent several errors that may occur due to insufficient levels of fetal DNA in the maternal blood.
Further, Panorama is a second-generation method producing highly accurate risk results, with significantly fewer false positives than other non-invasive tests. The company is of the view that the ability to assess Single-Nucleotide Polymorphisms is expected to considerably enhance the management of high risk pregnancies in the country.
The testing for Single-Nucleotide Polymorphisms will be done in MedGenome labs, he added.
“We are in the process of enrolling the hospitals and doctors to be participating in the research study and this is the first time such a study is being carried out in India,” stated the MedGenome chief.
MedGenome has its R&D lab at San Francisco and the India headquarters is within the Narayana Health City, Bengaluru. The company was incubated for 2 years as a division of SciGenom Labs, Kochi before it was spun off as a separate entity in 2013 to offer clinical diagnostic tests to major hospitals and clinics in the country. It partners with global players on genomic research and genome data analysis. Its proprietary cancer analytics platform, OncoMD, provides access to exhaustive curated content for cancer diagnostics and research. The company has around 100 workforce in India and the US.