Chilean creates device to detect HPV without the discomfort of a PAP smear
On the Entreprenerd podcast, Macarena Silva discusses the development of a solution aimed at avoiding the uncomfortable process that thousands of women go through when undergoing a Pap smear, also known as a PAP test, which is designed to detect the human papillomavirus.
AriHealth, the startup founded by Macarena Silva, UC designer, is developing a self-sampling solution to detect the human papillomavirus using PCR. Its goal is to reach the Chilean market by the end of 2027 and then expand to Mexico, Colombia, and Peru. She discussed her work in detail on the Entreprenerd podcast.
A Local Response to a Global Gap
Detect earlier, with less discomfort and greater accuracy. That is the promise behind AriTest, the first product from AriHealth, a Chilean startup founded by Macarena Silva that aims to transform the way women access preventive tests associated with the human papillomavirus -HPV- and, by extension, cervical cancer.
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The project was born in 2022, during Silva's thesis for a degree in Design at UC, and then escalated into a research supported by the VIU fund of ANID, which allowed him to finance approximately US$32,000 for the advancement of the device's development.
I designed a self-sampling method for HPV detection. Essentially, it greatly facilitates the collection of the sample itself.
Macarena Silva, founder and CEO of AriHealth.
Unlike the traditional PAP, AriTest is designed for the user to take her own sample in a bathroom, similar to other outpatient tests. Then, that sample is analyzed using PCR technology, which allows for the identification of the virus and its genotype.
From PAP to PCR: Precision and Prevention
One of AriHealth's main arguments is the technological shift: moving from PAP cytology to molecular analysis by PCR. According to Silva, PAP can have a sensitivity close to 50%, while PCR can reach levels of up to 98%.
"The difference between switching from PAP to PCR is brutal. That is, we're talking about going from 50% sensitivity to 98%," she says. For the founder, this not only implies a diagnostic improvement, but also an opportunity to reduce future costs for the health system by detecting risk cases earlier.
AriTest, adds, it does not seek to replace the clinical role, but to facilitate access to screening.
Our innovation lies in the format of the exam, in making it easier for women and also reducing the anxiety they face before the exam.
Macarena Slva, CEO of AriHealth, explains.
The aim is to address the issue of many women postponing their check-ups due to discomfort, lack of time, or difficulty accessing healthcare centers.
"Medical Design Thought from the Female Experience"
The device has a morphology similar to a tampon and was designed considering anatomy, usability, and user experience. Unlike other self-sampling models, AriTest incorporates a mechanism that automates the necessary movement to collect the sample.
"Women only have to insert, push, retract, and remove," Silva describes. The logic behind the development, she maintains, was to cross science with design: "We think about the person and ultimately we intersect with everything that has to do with science."
The startup already has a patent linked to UC, licensed to AriHealth, and is currently working with a team of five people, including designers and scientific profiles. In addition, the company is preparing clinical trials with around 250 patients, a key stage to compare its performance against clinical intake and other self-sampling devices.
Roadmap: Validation, Manufacturing and Regional Expansion
AriHealth is keeping a pre-seed round open for US$415 thousand, resources that it primarily intends to allocate to clinical validation, certifications, manufacturing, and commercial preparation. The company has already begun conversations with the ISP and projects its arrival in the Chilean market by the end of 2027.
The business model will be B2B2C: AriHealth hopes to sell the device to medical testing distributors, who already have channels to clinics, hospitals, CESFAM, and public tenders.
After Chile, the plan targets Mexico, Colombia, and Peru. However, the ambition goes beyond HPV: the startup is considering expanding the use of the sample to detect other sexually transmitted infections, vaginal microbiota, and future developments in women's sexual health.
"As a country, we are not accustomed to technological and scientific developments created here making a global impact. But that is exactly what we want: to leap from Chile to the rest of Latin America, to the rest of the world," Silva concludes.
