Adyn Test Brings Precision Medicine to Birth Control Prescription Choices

This is an effort to eliminate severe adverse reactions by matching the birth control to the genetics and hormones of the individual.

Adyn Founder and CEO Elizabeth Ruzzo, Ph.D./Courtesy of Adyn.

Adyn, a Seattle femtech company, is developing a test to determine the best birth control for individual women from among the 200 options currently available. This is an effort to eliminate severe adverse reactions by matching the birth control to the genetics and hormones of the individual.

There’s another reason, too. Research – as early as 1983 – shows more than a 12-fold difference in drug concentrations among women using the same hormonal contraceptive methods. Consequently, some hormonal contraceptive methods don’t work for some women. Until now, determining what works and what doesn’t work for specific people has been done by trial and error.

In the U.S., 65% of women between the ages of 15 and 49 use some form of birth control, according to the National Center for Health Statistics in the most recent (2017-2019) National Survey of Family Growth. Of those, 14% favored oral contraceptive pills, while 10.4% were using long-acting reversible contraceptives.

“Women may experience a wide range of side effects from their birth control medication,” Elizabeth Ruzzo, Ph.D., founder and CEO of Adyn, told BioSpace. They range from serious – including blood clots and debilitating anxiety – to milder effects such as changes in menstrual patterns and mood, weight gain and acne. Physicians don’t always take these changes seriously, and even when they do, they have had no precise, scientific test to inform their selections.

“It was a problem I experienced,” Ruzzo said. “I was prescribed birth control at an early age for a different condition, and there was no explanation of how or why that particular therapy was selected. Years later, I was suffering from depression which I believed was a side effect of the birth control medication. I even considered suicide. I talked with my physician, who assured me that [depression caused by hormonal contraception] wasn’t possible. A few months later, I went off the pill and felt better.”

Ruzzo, who holds a Ph.D. in genetics and genomics, knew that many other women experienced similar issues with their birth control and decided to help resolve the problem. The company she founded, Adyn, developed the Birth Control Optimization Test to provide scientific insights on an individual level to guide birth control prescription decisions.

“We send a kit to your home. It contains a tube to collect saliva [to extract and analyze your DNA] and a pinprick device to collect blood [and thus analyze hormone levels],” Ruzzo said. “We are looking for the individual’s predisposition to two of the most dangerous side effects of birth control – depression, and the formation of blood clots.”

Importantly, the kit also asks women about their birth control preferences based on features that are important to them, such as method of delivery and frequency of administration, and their timeline for trying to have children. “We conduct the analysis using all this data to help decide which birth control will be best,” Ruzzo said. “This is another data point” that women and their physicians can use. The kit will be available in Fall 2021 throughout the U.S., except in New York, New Jersey, and Rhode Island.

Once the test results are analyzed, Adyn connects the women to a telemedicine provider who is trained to understand the results. During the consultation, the provider discusses the pros and cons of the various contraception methods in light of the hormone and DNA analysis and the patient’s preferences. “A physical examination isn’t needed to prescribe birth control, except for the arm implants and IUDs,” she pointed out, so the provider can also write the prescription.

“The choice of birth control is up to the individual, based upon what makes sense for her,” Ruzzo emphasized. “Adyn recommends all highly effective methods, including the pill, patch, ring, shot, IUD and arm implant.”

DNA typically hasn’t been considered in the context of birth control. A landmark study published in Obstetrics & Gynecology in 2019 was the first to link genetic variants with the breakdown of etonogestrel metabolism. Specifically, it found that the CYP3A7*1C variant could increase the metabolism of steroid hormones and that this higher metabolism reduced the likelihood of consistent ovulatory suppression. Nearly 28% of the women in that study who had that variant also had lower etonogestrel concentrations. Those women, therefore, were more likely to become pregnant despite using contraceptive implants. The CYP3A7*1C variant is found in about 5% of adult women.

Ruzzo said this study shows “promise for the identification of genetic markers that impact birth control efficacy,” but cautioned, “we need these findings to be replicated independently.”

In the past four or five months, more than 600 women have signed up on the Adyn website to participate in a pilot program for this service. “A number of early adopters are going through the full experience,” Ruzzo said.

Eventually, Ruzzo said she plans to develop early diagnostic tests for endometriosis and polycystic ovary syndrome (PCOS), a condition in which the ovaries produce excess androgens. She said she hopes Adyn will become a trusted partner that helps women understand their health throughout their teen and adult lives.

In the femtech sector, funding has often been a challenge, executives in that industry have said. For Ruzzo, “The number one predictor has been if investors understand the problem. Women investors usually understood immediately, and men understood if they have partners or loved ones who had gone through it. That’s a common feature across women’s health.”

Last spring, Adyn raised a $2.5 million seed-funding round led by Lux Capital and M13, with contributions from an investor syndicate that includes Anne Wojcicki of 23andMe.