For a while now, science has allowed parents and doctors to stack the deck in their favour. At least to some extent. Various prenatal screening methods have allowed expecting parents a glimpse of the risks facing their unborn children. A chance to avoid having a child that will endure a compromised quality of life, or at least the opportunity to prepare for the challenges to come.
But these, too, are far from perfect. A trade-off between accuracy and safety. Non-invasive methods such as triple or quadruple screen tests are safe. However, with detection rates of 69% and 81%, respectively, there’s still a decent amount of uncertainty. Then there are the invasive procedures such as chorionic villus sampling (CVS) and amniocentesis. Highly accurate (98-99%), but with grave risks. In CVS, the risk of miscarriage is 1 in 200, while amniocentesis is slightly less risky, with miscarriages occurring in only 1 out of every 1,000 cases. Russian roulette, indeed.
A new generation of testing, however, may provide the succour that so many expecting parents desperately crave.
Non-invasive prenatal test (NIPT), developed in 2011, is the gold standard of prenatal testing. It requires a small amount of blood drawn from the mother’s arm, testing the child’s genes in the mother’s blood. Since it’s non-invasive, the risk of miscarriage plummets to zero. If that wasn’t already proof of its superiority, NIPT diagnoses 85% of all chromosomal abnormalities and has an accuracy of over 99%.
A no-brainer then, right?
NIPT has taken the developed world by storm. They are convinced that it is the prenatal test of the future. First introduced in 2011 in the US, the UK’s National Health Service is going to offer it to about 10,000 women this year who are considered at greater risk of giving birth to a baby with genetic disorders. In Canada, health insurers have started covering the test.
Back in India, though, things aren’t so straightforward. The path to mass adoption is strewn with obstacles. From affordability to convincing doctors, patients, institutions and governments of the benefits of NIPT over other methods. Will India embrace the future en masse? Or is NIPT destined to remain a luxury afforded to only the affluent and aware?
Genomics-based diagnostics company MedGenome is banking on the former. The company, which boasts of having the largest genome sequencing centre in south-east Asia, claims to be the first mover in the area of NIPT. But the first mover advantage goes only so far when the technology is readily available.
Convincing and kickbacks
As with any pioneering technology, education is the first step to adoption. To this end, MedGenome has spent the last two years conducting continuing medical education (CME) activities with societies of doctors as well individual doctors. “Clinician awareness is more important than patient awareness in India because they prescribe tests,” says V L Ramprasad, Chief Operating Officer of MedGenome.
In keeping with this, the company also published the first India-specific NIPT study earlier this year, to convince stakeholders that the benefits of NIPT are valid in India, too. The study, which analysed the results of over 500 women with low or high-risk pregnancies across 10 Indian hospitals, showed that NIPT is as effective on Indian women as it is abroad. With an accuracy rate of over 99%.
MedGenome’s efforts to educate and convince doctors have begun to pay off. Some doctors have adopted NIPT after being convinced by MedGenome’s study. Dr Arvind Kasaragod, Medical Services Director of Cloudnine hospitals, is one of them. For the last six months, Cloudnine, India’s leading chain of maternity hospitals, has offered its patients the option of NIPT.
Other doctors have been forced to see the light after conventional tests were found lacking. To illustrate the dangers of sticking to older testing methods, Ramprasad takes the example of Narayana Health in Bengaluru. In November 2017, a couple filed a complaint of medical negligence against the hospital after their baby was born with Down Syndrome. Conventional tests employed by the hospital failed to detect the genetic abnormality in the foetus.
According to a doctor and senior executive with a corporate hospital chain, who asked not to be named, there’s another, far murkier reason for some doctors not getting on board. Kickbacks. NIPT labs do not offer kickbacks for doctors who prescribe the procedure. The problem of kickbacks recently came to the fore in Telangana, where the Telangana State Medical Council (TSMC) issued notices to private labs for paying doctors a commission for referring patients to these labs. This practice often goes unchecked because state medical councils do not have authority over labs, reported The Lancet in 2o13.