This handheld device helps in early screening of cervical cancer

In the Interim Budget for 2024, Finance Minister Nirmala Sitharaman advocated for vaccination for girls in the age group 9-14 years to prevent cervical cancer.

Cervical cancer is the second most common cancer among women in India. According to a report by the George Institute for Global Health, the overall five-year relative survival of 46% for all cervical cancers is strongly determined by the stage at diagnosis, with survival as low as 7.4% for advanced stage disease compared with 73.2% for localised cancer.

This calls for early screening, which in turn leads to timely diagnosis and treatment. The current screening methods such as conventional cytology (PAP smear), liquid-based cytology (LBC), and human papillomavirus (HPV) testing can be time-consuming.

Pune-based Periwinkle Technologies, founded by Veena Moktali and Koustubh Naik, launched Smart Scope, a digital device, in 2019 to conduct cervical health screening in less than 10 minutes. The patented device, handy and easy to use, can be of immense use in the primary healthcare system, with easy access to screening in a single visit.

The husband-and-wife, both engineers who worked in the US and UK , returned to India in 2014.

While pursuing their Master’s, they became sure they wanted to do something on their own; they had worked on several enterprise application and product developments, especially with handheld devices and knew this was the domain they wanted to be in.

The need for accessible healthcare

The couple zeroed in on healthcare when they found that their ageing parents had to travel to bigger cities like Mumbai for treatment.

Moktali explains, “It was becoming difficult for them to travel regularly for treatment and follow-up visits. This was in 2011, when mobile phones had penetrated the market in a big way, and so we thought we could use our expertise and experience to create a platform to enable them to talk to their doctors or exchange clinical data,” she says.

They wanted to go beyond what companies like Practo were offering at that time, and during the initial exploratory phase that involved research, they met preventive oncology experts from Tata Memorial Centre that set them off on a different path altogether.

“We understood that the Indian public healthcare has specific problems related to cancer care. We were also introduced to screenings for the three large cancer killers—oral, breast, and cervical cancer,” she says.

While speaking to experts, the couple understood that while some symptoms of oral and breast cancer were physically visible and can be diagnosed early on, in the case of cervical cancer, the symptoms start showing almost six to 10 years after being infected by the virus.

While the HPV vaccine administered at the right age helps in prevention, Moktali points out that lab-based tests like the Pap Smear prevalent in private healthcare are not useful in the public healthcare system because of the processes and time involved.

“The test sample must be analysed at a lab, away from the woman’s location and results may take a few days. There are not many labs that do them quickly, and at the same time, women are reluctant to travel for follow-up visits. The cost of these tests is also quite prohibitive,” Moktali says.

While single visit screening and triaging was introduced by experts at the Tata Memorial Cancer Centre, wherein nurses were trained to perform a colcoscopy, after consultation with experts, they found that the results could be subjective.

“Keeping these factors in mind, we first developed the hardware, a handheld camera along with tablet that powers it and has the software. A nurse or community health worker can take this to women’s doorsteps for screening,” she adds.

The Smart Scope screening process

Moktali breaks down the process in simple terms.

When a woman above the age of 25 walks into the clinic, the doctor advises her to undergo a simple preventive test–an examination of the cervix. Using a Smart Scope, the doctor captures images of the cervix after the application of a chemical that helps in staining the epithelial cells temporarily. The Smart Scope’s AI analyses these images in under 30 seconds and gives the results.

If the three images result in a green color code, that means the cervix is normal. If the colour code is amber, that means the cervix has some benign condition such as an infection or a polyp. If the AI finds pre-cancerous changes in the cervix, it classifies the images with a red colour code.

“Depending on the severity of the pre-cancerous changes, we have now also introduced another colour which can distinguish between a low-grade pre-cancer and a high-grade pre-cancer. If the patient has a low-grade pre-cancerous cervix, she need not even be treated in the same visit; she can be counselled and asked to follow up after three or six months because her own immunity may prevail and the pre-cancer can even reverse in younger, healthier women,” Veena says.

They claim an accuracy rate of 90%. Smart Scope eliminates the need for mains electricity supply during the procedure, a lot of space, or other special infrastructure.

The Smart Scope was developed by partnering with a few hospitals like Tata Memorial Centre and Deenanath Mangeshkar Hospital for clinical validation. The product had a soft launch in 2019 by Biotechnology Industry Research Assistance Council (BIRAC) and currently has 350 installations across 18 different states in India. It is also being piloted in many states simultaneously and the couple hopes to penetrate the large public healthcare system in the country. It takes just two hours for a healthcare expert to learn how to operate the Smart Scope. So far, over two lakh women have been screened with the device.

“We have already applied for the USFDA license and are looking to market in a few countries in Africa to begin with our international expansion,” says Koustubh.

While the founders do not reveal the cost of the product, they are positioning it as a capital investment for governments to enable cervical cancer screening at an affordable rate.

Periwinkle has received grants from BIRAC and other agencies and raised equity funding in 2021. ACT For Health is also supporting Periwinkle in conducting an operational study to establish the benefits of Smart Scope® CX against the current prevalent naked eye VIA test.

“Our focus is to make the device available in as many states as possible. We are also looking at collaborations with governments and agencies to scale our efforts, and regulatory approvals for international expansion,” says Moktali.

(The copy has been updated to correct a typo)