Saving Lives Through the Early Detection of Pre-eclampsia

Intignus Biotech, a start-up associated with RICH through the AID programme

One of the many possible complications of pregnancy is pre-eclampsia. This is a serious disorder characterised by hypertension (high blood pressure), proteinuria (excess protein in the urine) and edema (swelling due to fluid build-up) of the legs and face. Other symptoms like intense headaches, nausea or vomiting, upper belly pain, decreased platelet levels in the blood, pulmonary edema (fluid in the lungs), cerebral haemorrhage (bleeding in the brain), stroke, and kidney failure, are also likely to develop in severe cases.

Although the exact cause of pre-eclampsia is still unknown, most doctors agree that it starts with a faulty placenta. The placenta is the organ that links the mother’s bloodsupply to that of the baby. This is why, when left untreated, pre-eclampsia can cause serious—or even fatal—complications for both mother and baby. The mother may develop eclampsia (sudden onset of seizures or coma) or placental abruption (separation of placenta from the uterine wall before delivery, leading to heavy, lifethreatening bleeding), and she may even sustain damage to other vital organs of her body. Oxygen supply depletion can severely harm foetus as well, sometimes leading to birth defects, learning and developmental disorders later in life, stunted growth, diabetes or pre-diabetes, and more.

If caught early, the condition can be treated by simple blood pressure control measures and routine observations by a healthcare provider, making the pregnancy safer for both mother and baby. But the main problem with this condition Preeclampsia typically develops after the 20th week of pregnancy. Therefore, diagnosis remains a huge challenge as symptoms vary from woman to woman. At this late stage of diagnosis, the only solution is to deliver the baby, but preterm babies (those born before the due date) are at risk to a host of other health complications.

The World Health Organisation (WHO) estimates that the incidence of pre-eclampsia is seven times higher in developing nations (2.8% of live births) as compared to the developed countries (0.4% of live births). True to this fact, in India, pre-eclampsia is one of the most commonly occurring hypertensive disorders during pregnancy. In fact, the number of preterm births in India is the highest in the world, and pre-eclampsia is the biggest risk factor behind it.

In addition to the general diagnostic challenges with pre-eclampsia, India faces several unique challenges. One of the few tests in the market that can effectively diagnose pre-eclampsia before 20 weeks of pregnancy, the PIGF ELISA test, is expensive and an elite test available only to women in tier 1 cities who can afford it. There is a clear need for better and more accessible options.

Having suffered from pre-eclampsia herself and known several other women with the complication, Vaishnavi Kulkarni, a researcher in biotechnology recognised this needand came up with a unique idea to create a disposable test kit, much like a pregnancy test or a COVID rapid test. To develop her idea into a product, she founded Intignus Biotech.

“Pre-eclampsia is growing at an annual rate of 25%,” says Vaishnavi, “which is a huge concern. But leaving aside the causes of this rise in incidence, which as still being explored, this calls for a point-of-care diagnostic device that can catch the disease early and reduce not only the risks to pregnancy, but the long-term healthcare costs for these mothers.”

Intignus’ pre-eclampsia test is a strip onto which a user is required to place two drops of their blood. Similar to the COVID rapid test, which has two marker (T) lines, this test has three lines. If a single line develops, it means the woman is not at risk of developing pre-eclampsia. If there are two lines, it means the woman is at low to moderate risk, and three lines imply high risk or that symptoms of pre-eclampsia could start manifesting anytime then. The device produces results in 15 minutes based on the detection of a biomarker for pre-eclampsia, a placental origin-based receptor protein.

Another unique feature of the test is that of the four types of hypertensive disorders in pregnancy—chronic hypertension, gestational hypertension, chronic hypertension with superimposed pre-eclampsia, and pre-eclampsia-eclampsia—it selectively and specifically detects only the last two, with high accuracy.

“Our goal is to make this test a part of the six routine check-ups that a woman must have during her pregnancy. The results can direct doctors and patients towards higher or lower levels of alertness for the onset of the condition and ensure timely intervention. Those at high risk can test more frequently as well, given the affordability and ease of conducting the test,” explains Vaishnavi. “We’re pushing for the product to be available at not only hospitals, but clinics, pathology labs, and IVF centres as well.” Intignus has filed for an international patent for this device and is currently moving to clinical trials with it. The team awaits regulatory approvals and hopes to launch this test in the market by the third quarter of 2023.

According to Vaishnavi, “Pregnancy is a complicated and vast field. Women’s health is an even vaster field.” She says, “if I can contribute to making women’s lives better by providing solutions to maternity problems, then why not?”

Her next goal is to create a product that deals with the sudden onset of labour in pregnant women. Through their innovations, the Intignus Biotech team hopes to revolutionise the healthcare market for women in India and provide accessible and affordable diagnostic tools to pregnant mothers in every corner of our country.

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