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This HPV test kit is home-grown, affordable and gives fast results: Can it be a mass screening tool?
This HPV test kit is home-grown, affordable and gives fast results: Can it be a mass screening tool?

Indian Express

time29-04-2025

  • Health
  • Indian Express

This HPV test kit is home-grown, affordable and gives fast results: Can it be a mass screening tool?

A new indigenously developed diagnostic kit for human papilloma virus (HPV) is likely to become available soon, making the test cheaper, easy to use and more accessible. 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.

India's first indigenously developed HPV test kits for cervical cancer screening validated
India's first indigenously developed HPV test kits for cervical cancer screening validated

The Hindu

time25-04-2025

  • Health
  • The Hindu

India's first indigenously developed HPV test kits for cervical cancer screening validated

The Department of Biotechnology (DBT), through its Grand Challenges India (GCI) initiative at BIRAC, has announced the successful scientific review and validation of India's first indigenously developed Human Papillomavirus (HPV) test kits for cervical cancer screening. These test kits, developed by Molbio Diagnostics Limited, Bangalore, and Mylab Discovery Solutions Pvt. Ltd., Pune, are a significant leap forward in improving cancer diagnostics in the country. The HPV point-of-care test kits underwent rigorous validation by a research team at the All India Institute of Medical Sciences (AIIMS), New Delhi, in collaboration with the National Institute of Cancer Prevention and Research (NICPR), Noida, and the National Institute for Research in Reproductive and Child Health (NIRRCH), Mumbai. The validation process also included a partnership with the World Health Organization's International Agency for Research on Cancer (IARC). The kits, which employ a chip-based RT-PCR testing method, facilitate rapid and decentralised detection of eight high-risk HPV genotypes - accounting for over 96% of cervical cancer cases worldwide. This technological advancement provides an affordable and efficient solution for widespread cervical cancer screening, particularly in resource-limited settings. Jitendra Kumar, Managing Director of BIRAC, underscored the critical importance of accessible and accurate diagnostic tools. 'The validation of Truenat® HPV-HR Plus (Molbio) and Patho detect (Mylab) marks a significant achievement in enhancing cervical cancer screening for women across India. This initiative highlights the strength of indigenous innovation in driving early detection and saving lives,' he stated. Cervical cancer continues to be a major health challenge in India, accounting for nearly 25% of global cases. With more than 1,23,000 new diagnoses and approximately 77,000 deaths annually, it remains the second most prevalent cancer among Indian women, despite being preventable through timely screening. In line with the Global Declaration for Cervical Cancer Elimination, the World Health Organization (WHO) advocates for the transition to HPV testing in all countries. The WHO's goal is to ensure that by 2030, 70% of eligible women will be screened through HPV testing at age 35 and again at age 45, with only two tests required over a lifetime.

Indigenously developed HPV test kits for cervical cancer screening launched in Delhi
Indigenously developed HPV test kits for cervical cancer screening launched in Delhi

Time of India

time24-04-2025

  • Health
  • Time of India

Indigenously developed HPV test kits for cervical cancer screening launched in Delhi

New Delhi: Indigenously developed (Human papillomavirus) HPV test kits for cervical cancer screening were launched here on Wednesday. The test kits have been developed under the Department of Biotechnology's (DBT) partnership programme Grand Challenges India (GCI) at the Biotechnology Industry Research Assistance Council (BIRAC). The DBT supported research coordinated by the All India Institute of Medical Sciences ( AIIMS ) Delhi, with testing done at laboratories at AIIMS, National Institute of Cancer Prevention and Research (NICPR), Noida; and the National Institute for Research in Reproductive and Child Health (NIRRCH), Mumbai, in collaboration with World Health Organisation (WHO) International Agency for Research on Cancer (IARC). "The key feature of these kits is the inclusion of only the seven-eight most common cancer-causing types that will allow a very efficient and cost-effective screening programme which will be most suitable for India," Dr Neerja Bhatla, former head of the department of Obstetrics and Gynaecology at AIIMS, Delhi and chief coordinator of the programme said. The study titled 'Validation of Indigenous Human Papillomavirus Tests for Cervical Cancer Screening in India (i-HPV)' validated indigenously developed, rapid, point-of-care, RTPCR-based HPV diagnostic test kits for screening cervical cancer in premier research and development laboratories of India. "Given the enhancement of RTPCR-based diagnostic facilities across the nation in the post-COVID era, the introduction of sensitive RTPCR-based HPV testing kits might prove to be cost effective screening method over classical HPV DNA and Pap smear for deployment in the national cancer screening programme ," Dr Bhatla said. Cancer of the uterine cervix is the second most common cancer among Indian women. According to WHO data, one out of every five women in the world suffering from the disease is an Indian, Dr Bhatla stated. Besides the high incidence of cervical cancer owing to its late diagnosis and with consequent poor survival, 25 per cent of global mortality due to cervical cancer occurs in India, she said. Thus, there has been a pressing need for the development of control strategies for the prevention and screening of cervical cancer. The currently available methods of screening of cervical cancer include Visual Inspection with Acetic Acid (VIA), Papanicolaou test (Pap test or Pap smear) and HPV DNA testing, she stated. Regular population screening by Pap smears has been successfully implemented in the developed world. Nevertheless, it is costly, resource-intensive and only moderately sensitive. VIA screening requires considerable training and re-training for quality assurance and has high false positivity rates with programmatic challenges, she said. HPV testing has the best diagnostic accuracy if it conforms to international standards of validation. As part of the Global Declaration for Cervical Cancer Elimination, WHO recommends a transition to HPV testing in all countries, whereby only two tests in a lifetime, at age 35 and again by age 45 years, will be sufficient. The target is to set up processes to screen 70 per cent of eligible women by 2030, Dr Bhatla stated.

Indigenously developed HPV test kits for cervical cancer screening launched in Delhi
Indigenously developed HPV test kits for cervical cancer screening launched in Delhi

The Hindu

time24-04-2025

  • Health
  • The Hindu

Indigenously developed HPV test kits for cervical cancer screening launched in Delhi

Indigenously developed (Human papillomavirus) HPV test kits for cervical cancer screening were launched on Wednesday (April 23, 2025). The test kits have been developed under the Department of Biotechnology's (DBT) partnership programme Grand Challenges India (GCI) at the Biotechnology Industry Research Assistance Council (BIRAC). The DBT supported research coordinated by the All India Institute of Medical Sciences (AIIMS) Delhi, with testing done at laboratories at AIIMS, National Institute of Cancer Prevention and Research (NICPR), Noida; and the National Institute for Research in Reproductive and Child Health (NIRRCH), Mumbai, in collaboration with World Health Organisation (WHO) International Agency for Research on Cancer (IARC). "The key feature of these kits is the inclusion of only the seven-eight most common cancer-causing types that will allow a very efficient and cost-effective screening programme which will be most suitable for India," Dr Neerja Bhatla, former head of the department of Obstetrics and Gynaecology at AIIMS, Delhi and chief coordinator of the programme said. The study titled 'Validation of Indigenous Human Papillomavirus Tests for Cervical Cancer Screening in India (i-HPV)' validated indigenously developed, rapid, point-of-care, RTPCR-based HPV diagnostic test kits for screening cervical cancer in premier research and development laboratories of India. "Given the enhancement of RTPCR-based diagnostic facilities across the nation in the post-COVID era, the introduction of sensitive RTPCR-based HPV testing kits might prove to be cost effective screening method over classical HPV DNA and Pap smear for deployment in the national cancer screening programme," Dr Bhatla said. Cancer of the uterine cervix is the second most common cancer among Indian women. According to WHO data, one out of every five women in the world suffering from the disease is an Indian, Dr Bhatla stated. Besides the high incidence of cervical cancer owing to its late diagnosis and with consequent poor survival, 25% of global mortality due to cervical cancer occurs in India, she said. Thus, there has been a pressing need for the development of control strategies for the prevention and screening of cervical cancer. The currently available methods of screening of cervical cancer include Visual Inspection with Acetic Acid (VIA), Papanicolaou test (Pap test or Pap smear) and HPV DNA testing, she stated. Regular population screening by Pap smears has been successfully implemented in the developed world. Nevertheless, it is costly, resource-intensive and only moderately sensitive. VIA screening requires considerable training and re-training for quality assurance and has high false positivity rates with programmatic challenges, she said. HPV testing has the best diagnostic accuracy if it conforms to international standards of validation. As part of the Global Declaration for Cervical Cancer Elimination, WHO recommends a transition to HPV testing in all countries, whereby only two tests in a lifetime, at age 35 and again by age 45 years, will be sufficient. The target is to set up processes to screen 70% of eligible women by 2030, Dr. Bhatla stated.

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