This HPV test kit is home-grown, affordable and gives fast results: Can it be a mass screening tool?
Developed by Molbio Diagnostics — which is known for providing low-cost tests for the country's TB programme — the molecular test will look for eight high-risk HPV strains by amplifying genetic material in the patient samples, similar to an RT-PCR test.
The kit was validated in a large multi-centre study funded by the Department of Biotechnology under its programme Grand Challenges India. 'Over 90 per cent of cervical cancer cases — which is one of the most common cancers among women — are caused by persistent HPV infections. In fact, the infection can cause cancers in men too. It is our responsibility to ensure access to vaccination and screening for this preventable cancer,' says Union Science Minister Dr Jitendra Singh.
While the kit is not part of a national programme yet, its user-friendly and fast-result oriented features make it a good match as a mass screening tool. India is also planning to vaccinate girl children between the ages of 9 and 14 years.
Why is the new kit significant?
One, the test can identify eight high-risk strains of HPV that cause 96 per cent of all cervical cancer cases across the world. Most of the existing test kits can identify only four of the most common strains. As the strains were selected based on global prevalence data, these kits can be used uniformly across the world.
Two, the test results can be obtained within an hour. Three, this new test kit can be handled in the remotest areas since it works on a TrueNat machine — a small, portable, cartridge-based molecular testing device. While a molecular test like RT-PCR requires a full-fledged lab and trained people to mix reagents appropriately and isolate the genetic material of a pathogen, even a minimally trained person can take samples for TrueNat where the reagents already come mixed in the cartridge. The machine is battery-powered and can be operated without electricity.
Four, there are already 8,000 TrueNat machines available across India, many of which are being used in the government system under the country's National TB Elimination programme.
Five, it is a molecular test and hence requires very little sample to give the result. 'There is reasonable evidence available to show that even vaginal swabs can be as effective as cervical swabs for detecting HPV in molecular tests,' says Dr Chadrasekhar Nair, chief technology officer, Molbio. This means that samples collected through less invasive methods can also be used.
What is the future direction of research?
The company is now looking at whether they could test for the virus in urine samples of patients. 'This will be completely non-invasive. Of course, we have to study the viral load in urine samples and see if they are clinically significant,' says Dr Nair.
Screening for cervical cancer is usually done either using a pap smear (cells collected from the cervix are tested under microscope) or through visual inspection with acetic acid (a 3 – 5% solution of acetic acid is applied on the cervix to see if it forms white patches). Both of these methods require opening up the cervix, which many are hesitant about. A urine-based test would solve that problem.
When will it become available and at what cost?
The company has received a manufacturing licence and has started manufacturing the kits already. 'We should be able to launch this soon. While I would not be able to give you the cost yet, it will definitely be one of the most affordable tests globally,' says Dr Nair.
What is the burden of cervical cancer?
India reported 1.27 lakh cervical cancer cases and 79,979 deaths in 2022, according to data from the World Health Organisation's Global Cancer Observatory. It is the second most common cancer in India among women, after breast cancer. It is also one of the few vaccine-preventable cancers.
Evidence from the UK shows that cervical cancer rates dropped by 87% in 20- to 30-year-olds who had received the vaccine by the time they turned 13. A study from Sweden showed that the incidence of cervical cancer was 47 cases per 100,000 among vaccinated women as compared to 94 cases per 100,000 among unvaccinated women.
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