The cervical sample self-collector test kit enables women to find out quickly if they have a lesion (credit: Ziel Biosciences)

Published on 01/02/2024

By Roseli Andrion  |  FAPESP Innovative R&D — Cervical cancer is the third most common cancer among women in regions of Brazil with a low human development index (HDI), according to the National Cancer Institute (INCA). Its incidence could be reduced if women in the appropriate age group had access to regular screening tests.

Ziel Biosciences, a startup supported by FAPESP’s Innovative Research in Small Business Program (PIPE), has developed a cervical sample self-collection kit that can immediately detect cancer cells, somewhat similarly to a store-bought pregnancy test.

If the result is negative, the test should be repeated a year later. If positive, the woman should consult a specialist. “It’s only for screening. It empowers women to do their own test and go to the doctor at once if it’s positive,” said Caroline Brunetto de Farias, CEO of Ziel Biosciences.

The goal of the project supported by FAPESP, Farias recalled, was to find out whether a specific biomarker could indirectly point to the presence of human papillomavirus (HPV) and use this as a basis for a future rapid test to detect infection by the pathogen. “To our surprise, we discovered that it doesn’t show whether the woman has HPV. In fact, it detects the existence of a cervical lesion,” she said.

Biomarkers are indicators of differences between healthy and diseased cells, enabling physicians to prescribe personalized or targeted treatment for each case. “They help establish precision oncology via the development of specific options that are less toxic for patients,” Farias said, explaining that understanding what the biomarkers identified was fundamental in order to proceed with the project.

“The discovery was very important because it was so specific,” she said. The team found that a healthy cervix lacked the signature, which was detectable only when cancer cells were present, and the rapid test indicated the existence of a lesion instead of contamination by HPV.

Infection by HPV can lead to cervical cancer but does not always do so. “The problem becomes serious when the virus persists in an organism. It’s a silent virus that can cause a lesion in two to five years if the body can’t eliminate it,” she said.

Unique test

There are other self-sampling test kits on the market, but this one is unique because it is the only one that performs liquid-based cytology (LBC) instantaneously. “No rapid tests for cervical cancer exist anywhere in the world. That’s exactly what we’ve patented. We want to see it distributed throughout Brazil and other countries with similar conditions,” Farias said.

Ziel is partnering with city governments to have municipal health workers call on local women and give them the collector. “They prioritize women who live in rural and other low-income areas. They don’t go to public health clinics, because they can’t afford the fare, or they may be trans, or perhaps they don’t feel comfortable with male nurses. Whatever the reason, they can self-test and take the result to a doctor, who will discuss the case and decide if treatment is necessary,” Farias said.

The price consumers will have to pay for the kit in pharmacies is not yet known. “Everything has changed since the pandemic. For example, it used to cost about 18 Brazilian Reais (BRL) to produce the collector, but it now costs about BRL40, and we imagine the complete test will probably cost about BRL 50-60,” she said, adding that the cost will fall once sales ramp up to meet demand. The BRL/USD exchange rate is currently in the range of 4.80-4.95.

It may also be possible to win approval for distribution of the test kit by the SUS (Sistema Único de Saúde, Brazil’s national health service). Prevention is much less expensive than treatment, Farias recalls. “The point is for women to have the comfort of undergoing the test without having to talk to anyone if they’re shy about it. We want it to be accessible to everyone who uses pharmacies and health clinics in the SUS system,” she said.

Mass screening

This outcome would be positive from a public health policy perspective, as it would make mass screening feasible. “It could optimize the use of resources by the SUS. Some women go to their local public health clinic once a year, but this way they could go every two years, for example. A rapid test would enable clinics to screen more women in a given period and reduce the incidence of cervical cancer in Brazil,” Farias said.

Screening by the SUS should reach some 40 million women, she reckons, or 60 million if those who use private clinics are included. “In 2021, the latest year for which we have statistics, only 15% of all women had a Pap smear. Cervical cancer is 100% preventable. It being the third most common cancer is unacceptable. Not enough is being done to combat the disease,” she said.

Farias has a PhD in cellular and molecular biology. She chose this area because she wanted to find a cure for cancer. “I was a dreamer. It’s a very tough task. On the other hand, while a physician can see one patient at a time, scientists who develop medications and diagnostic tests can reach many people at once,” she said.

Besides working at Ziel Biosciences, she teaches at the Federal University of Rio Grande do Sul (UFGRS) and the Federal University of Rio de Janeiro (UFRJ). “I teach scientific entrepreneurship for graduate students, for example. I want students to think about how to transform a master’s or PhD thesis into a product or service that benefits society,” she said.

Ziel Biosciences is currently developing a smartphone app to work with the self-collection and rapid test kit. “The woman will be able to photograph the test result so that the app can interpret it while the stripe is still very faint, for example, indicating whether she should see a doctor immediately or can wait a year to repeat the test,” Farias said.

It is also worth noting that the same concept can be applied in other self-collection diagnostic tests using blood, saliva or urine samples. “Depending on the type of tumor, we can develop the right collectors for other rapid tests that give people more autonomy in terms of healthcare,” Farias said.

 

Source: https://agencia.fapesp.br/50539