At-home hormone testing aims to transform fertility care

Imagine being able to monitor your hormones from the comfort of your own home with the same accuracy as a high-tech medical lab. Thanks to a team of researchers at the University of Chicago Pritzker School of Molecular Engineering (UChicago PME) and Kompass Diagnostics, that future may be near.

UChicago PME scientists and their collaborators developed a groundbreaking handheld device that quantifies levels of the female fertility hormone estradiol using a simple paper test strip and a drop of blood. The new approach could transform fertility testing and in-vitro fertilization (IVF), which usually require women to visit a lab every few days to monitor levels of estradiol and other hormones over time.

“This technology could be really impactful,” said Junhong Chen, the Crown Family Professor of Molecular Engineering and senior author of the new paper, published today in Device. “Low-cost, accurate home hormone tests could save on a huge amount of medical costs as well as eliminate lots of the burden on patients.”

Making at-home testing more accurate

For years, healthcare providers and patients have struggled with the challenges of at-home diagnostic tests. While conventional tools like home pregnancy tests or COVID-19 tests provide quick and convenient results, they generally lack the precision and sensitivity required to yield quantitative results. These tests produce a 'positive' or 'negative' result based solely on the presence or absence of a colored line, which is inadequate for accurately measuring hormone levels. The research team has developed an assay technology that integrates the simplicity of rapid test strips with advanced electronics to deliver lab-quality results.

Chen’s group, which also develops sensors for water quality, has spearheaded a technology in which the reaction to detect a chemical — whether an impurity in water or a hormone in blood — generates charged protons. The protons on a test strip are then measured electronically by a handheld reader — about the size of a credit card — that plugs into a smartphone or displays results directly. In the past, the team has used their approach to measure cholesterol levels.

In the new paper, Chen, postdoctoral researcher and first author Hyun-June Jang, and colleagues, including Associate Professor Jun Huang, showed that their platform could quickly and accurately measure estradiol levels, which are known to fluctuate significantly throughout a woman’s menstrual cycle. They also chose estradiol as a proof-of-concept because it’s notoriously difficult to detect accurately, even in lab settings.

The group – in collaboration with University of Chicago Medicine researchers led by Jerry Yeo – tested 23 clinical plasma samples with estradiol ranging from 19 to 4,551 picograms per milliliter (pg/mL), reflecting the range of levels seen in people. The new test closely matched lab results, with a 96.3% correlation to the gold-standard, FDA-approved test which is carried out with specialized lab equipment. Moreover, results were provided in about ten minutes and at an estimated cost of 55 cents per test.

“We could get just as accurate results at a much lower cost and much faster,” said Jang.

Applications across healthcare

Typically, women undergoing fertility treatments must get hormone tests to pinpoint when levels of hormones — such as estradiol — peak. For each test, blood samples must be sent to a specialized lab, which can delay results and affect treatment outcomes. Each lab test adds time, expense, and stress.

'“The process right now is exhausting and expensive,” Jang said. “Some patients must rent hotel rooms for two weeks during IVF so they can stay close to a clinic. With this device, they could do the test from home and still get the same quality of information.”

The test is not yet available to consumers, but efforts are underway to gain FDA approval and bring it to market. Jang has launched a startup, Kompass Diagnostics, leveraging the I-Corps and accelerator programs at UChicago’s Polsky Center to kickstart commercialization efforts. The company has raised $1.6 million in seed funding, has been awarded a National Science Foundation SBIR grant, and is collaborating with the University of Chicago’s Polsky Center for innovation and licensing.

Initially, the team plans to deploy the platform through fertility clinics, where doctors can interpret the data and monitor patient progress. But eventually, they hope it will be simple enough for anyone to use, turning complex blood testing into something as routine as checking your temperature.

They also say that the same technology can be used to monitor hormones other than estradiol (they are working on an index-card-sized cartridge that measures multiple fertility hormones) or other molecules in blood — including cancer biomarkers, Alzheimer’s biomarker or infections.

“For any kind of biomarker testing that requires frequent checking, accurate at-home-tests have been a Holy Grail, and this gets us closer to that,” said Chen.

Citation: “Radical-mediated Electrical Enzyme Assay for At-home Clinical Test,” Jang et al, Device, May 23, 2025. DOI: 10.1016/j.device.2025.100807

Funding: This work was supported by University of Chicago Faculty Start-up Funding and by the Walder Foundation.