The Supreme Court’s landmark 6-3 decision overturning 50 years of federal abortion protections sent shockwaves across the U.S. Friday and has suddenly restricted or threatened abortion access in half of the country.
In total, 26 states have already, or have been deemed likely to, restrict abortion rights following the Dobbs v. Jackson Women’s Health Organization decision, which reversed the constitutional right to abortion granted in the court’s 1972 Roe v. Wade opinion. As abortion protections erode across these states, access to effective and safe contraceptive methods could become more important than ever for women, says Elizabeth Ruzzo, founder and CEO of the precision medicine company Adyn.
“It’s a terrifying time,” she says of the potential policy changes. “It's a really important time to be out there loudly educating and also working on improving accessibility as much as we can.”
In May, Adyn commercialized its first product, a hormonal and genetic birth control diagnostic aimed at eliminating one of the largest barriers to contraceptive access for women: side effects.
Sixty-five percent of women ages 15 to 49 are currently using contraception and, on average, they spend 30 years of their life on the medication. Yet most try four or more methods of birth control before settling on one that works, often because of intense side effects, such as blood clotting and depression. Side effects are also the No. 1 reason people discontinue hormonal contraceptive use, including among 63% of people using the pill and 45% of people using the patch.
Adyn’s Birth Control Test seeks to eliminate the worst of these effects by analyzing a user’s hormones and genetic makeup for roughly two dozen triggers that may increase their propensity for experiencing negative outcomes.
“A trigger is anything like a past history that you've recorded or one of these biological markers that we're looking at that help us give you a personalized set of recommendations for which options may or may not be good for you, amongst them, nearly 200 highly effective methods of birth control,” Ruzzo says.
Eventually, she expects the data collected will help better inform which genetic markers and birth control formulations result in certain side effects, and aid in the creation of diagnostics for other conditions that typically impact women.
“The idea is that we would hopefully partner with these individuals to understand their hormones, which change not just throughout the month, but throughout the course of their life at some of those different time points,” she says of the company’s goals.
The launchpad
Adyn’s mission is personal for Ruzzo. At age 18, she experienced severe depression while taking the pill in combination with the acne medication Accutane. But her doctor dismissed birth control as the cause of her mental health challenges.
When Ruzzo decided to finally stop taking birth control, her symptoms quickly subsided and she learned that others her age were also experiencing side effects from different versions of the pill.
Ten years later while completing her Ph.D. in genetics at Duke University, Ruzzo discovered that a lack of understanding about birth control side effects could be partially attributed to gaps in medical research and data about female biology and non-European populations.
“There are 97 different disorders that have been identified as differentially or solely impacting people assigned female at birth that have been categorically understudied compared to disorders that impact either men or both sexes more equally,” she says. “Those were areas that I knew I wanted to spend my life working on.”
The Birth Control Test is a jumping off point for the company, she explains.
“Starting with birth control has huge implications because women take it on average for three decades,” Ruzzo says of the initiative.
Much like at-home genetic tests, The Birth Control Test asks users to collect a saliva sample for DNA testing and a finger-prick of blood for hormonal testing that they send to a lab. There, clinicians analyze several sites in the genome known to increase an individual’s risk of experiencing blood-clotting and use a polygenic risk score to determine risk for depression.
Users are sent the results and can review them with a trained medical professional during a 30-minute contraceptive counseling appointment, after which they can order the birth control best suited for them directly through Adyn, which partners with a small independent pharmacy.
“The average contraceptive counseling appointment in the U.S. is 13 minutes. Ours are nearly double that,” Ruzzo says. “We have been able to interview and select which experts we want to work with. And we spend a lot of time training them not only on how to understand the report, but also on how to make sure they're delivering culturally competent, inclusive care during those visits.”
But The Birth Control Test is just the beginning of Ruzzo’s attempt to understand the genetics and hormones that might lead to some of these disorders.
Users also may opt in to have their data anonymously analyzed as part of Adyn’s Close the Gap research initiative, currently under review by the FDA’s Institutional Review Board, to increase the understanding of women’s and non-European populations’ medical needs.
“I hope that we can use that data we're collecting to develop more diagnostics and companion diagnostic tools like The Birth Control Test, to create medically actionable decisions for clinicians to get better at doing their job and make everyone's experience as personalized as possible,” Ruzzo says.
"The idea is that we would hopefully partner with these individuals to understand their hormones, which changed not just throughout the month, but throughout the course of their life at some of those different time points."
Elizabeth Ruzzo
CEO of Adyn
And, while Ruzzo says her initial vision is to focus on those 97 conditions that disproportionately impact people assigned female at birth, she says “there’s no reason to think that some of the approaches we are doing couldn’t be important” for other indication areas as well.
Improving access
One of Adyn’s central missions is to make scientific discovery more inclusive by building better data sets to advance personalized medicine for under-researched populations. But Ruzzo admits that access barriers remain for The Birth Control Test.
The test retails for $369 and is eligible for coverage through Health Savings Account and Flexible Spending Account options. The company is also working to offer a buy now, pay later option and is “actively pursuing insurance coverage,” she says.
“Accessibility is super important for me, especially when given our mission of making scientific discovery more inclusive. I want it to be as accessible as possible,” she says. “And I think there is a strong economic case to be made for insurance companies to support avoiding trial and error when prescribing birth control.”
She argues that the “prescription cascade” caused by less accurate contraceptive prescriptions that force birth control users to go to multiple medical appointments to fix compounding issues can cost insurance companies more than the test.
As for fears that the Supreme Court’s Dobbs decision could also lead some states to further restrict access to contraceptives, Ruzzo similarly says a “really strong economic case” could and should be made for the right to birth control.
“As a scientific community, we have the responsibility to be sure that we're out there loudly educating about the merits of birth control and how it actually works, and then reminding people that birth control is medicine,” she says. “It's more important than ever to both educate and make sure that we can get [The Birth Control Test] and the right birth control into as many hands as possible as quickly as possible.”
