New Delhi, Jun 15 (PTI) An indigenous point-of-care HPV test has emerged as a promising low-cost tool for cervical cancer screening, with a multinational validation study finding that it meets international performance standards and could significantly expand access to early detection in resource-constrained settings.
The study, published in the International Journal of Cancer in June, found that Truenat HR-HPV-Plus satisfied all International Agency for Research on Cancer (IARC) reduced-valency and non-inferiority validation criteria, making it the first formally validated reduced-valency HPV assay targeting seven to eight high-risk HPV types.
Researchers reported that the test demonstrated 80.4 per cent sensitivity and 91.5 per cent specificity for detecting cervical intraepithelial neoplasia grade 2 or worse , a key precursor to cervical cancer.
The assay also showed high inter-laboratory agreement of 93.3 per cent.
“Cervical cancer is one of the few cancers where we know the cause, we have prevention tools, and we can detect risk early. Yet, thousands of women in India continue to be diagnosed late because screening does not reach them at the right time and in the right setting,” Dr Neerja Bhatla, Professor Emeritus at the National Cancer Institute, AIIMS, Jhajjar, said.
Former head of the Department of Obstetrics and Gynaecology at AIIMS Delhi, Dr Bhatla, who is the lead author of the study, said for many women above 30 years of age screening is the most immediate strategy for reducing cervical cancer risk.
“We need robust screening systems that can identify women at risk before cancer develops. HPV DNA testing is central to this strategy,” she said.
The World Health Organisation (WHO) recommends HPV DNA testing as the preferred method for cervical cancer screening because it is more sensitive than cytology (Pap smear) in identifying women at risk of developing cervical pre-cancer and cancer.
However, adoption has remained limited in many low and middle-income countries because of cost, laboratory infrastructure requirements, long turnaround times, and challenges in ensuring follow-up, Dr Bhatla pointed out.
According to the researchers, the higher specificity could reduce unnecessary referrals and follow-up procedures, making the test a reliable, cost-effective and scalable option for cervical cancer screening in India and other low- and middle-income countries (LMICs).
The validation drew on cervical samples from the ESTAMPA study, a multi-centric cervical cancer screening programme conducted across Latin America that screened 44,135 women aged 30-64 years between 2012 and 2022.
Samples for the validation were sourced from the IARC biorepository and obtained from study centres in San Jose, Costa Rica, and Buenos Aires, Argentina.
The study involved a collaboration between AIIMS, Delhi, ICMR-National Institute of Cancer Prevention and Research (NICPR), Noida, ICMR-National Institute for Research on Women’s Health (NIRWoH), Mumbai, DBT-BIRAC, IARC/WHO, the University of Antwerp, ANLIS Malbran in Argentina and Caja Costarricense de Seguro Social in Costa Rica.
Testing responsibilities were distributed across Indian institutions, including AIIMS, ICMR-NIRWoH and ICMR-NICPR.
Cervical cancer remains a major public health challenge in India, accounting for an estimated 127,000 new cases and about 80,000 deaths annually.
While screening can identify precancerous lesions before they progress to cancer, coverage remains low despite the inclusion of cervical cancer screening under national programmes.
Persistent infection with carcinogenic HPV types is the necessary cause of cervical cancer. The WHO recommends HPV testing as the preferred strategy for cervical cancer elimination, with evidence suggesting that screening women twice — at ages 35 and 45 years — using validated HPV tests can substantially reduce disease burden.
However, most currently available HPV tests are expensive and require sophisticated laboratory infrastructure, limiting their use in many LMICs, Dr Bhatla said.
She said the study was among the first to evaluate Indian-developed reduced-valency HPV assays using WHO Target Product Profile and IARC validation criteria.
“The study demonstrates that indigenous platforms can achieve clinical validation, quality standards and accuracy comparable to global gold-standard tests. It has the potential to be a game-changer for cervical cancer prevention and early detection in India,” she said.
ICMR-NICPR director Dr Shalini Singh said affordable indigenous HPV testing solutions were critical for expanding screening coverage and advancing WHO’s cervical cancer elimination goals.
Dr Showket Hussain, one of the corresponding authors, said the validated platform could be readily integrated into screening programmes because healthcare personnel at district-level facilities were already familiar with the technology.
He added that future developments, including self-sampling and high-throughput adaptations, could further improve access.
Researchers noted that while HPV vaccination is expected to substantially reduce future disease burden, effective screening remains essential for women above 30 years of age who remain at risk of cervical cancer.
Notably, other assays evaluated in the study did not meet the required validation benchmarks, underscoring the significance of the Truenat HR-HPV-Plus findings for India-led diagnostic innovation. PTI PLB DV DV
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