The idea for a biodegradable pregnancy test came to Bethany Edwards and Anna Simpson in graduate school.
The Temple University alums were looking for ways to make everyday health care products sustainable while working on their master’s degrees at PennDesign — and the at-home pregnancy test stood out.
“It hadn’t been functionally updated in 40 years,” said Edwards. “It was the same stiff plastic stick. What people were doing was adding expensive digital landfill-based components, but nobody was innovating on the sustainability side.”
After graduation, Edwards and Simpson formed their Philadelphia-based company, Lia Diagnostics, in 2015 to research and develop their idea. The U.S. Food and Drug Administration approved the idea earlier this month.
When they started talking to women about being able to flush a pregnancy test after using it, privacy emerged as a big selling point.
“Who hasn’t hidden a pregnancy test in the trash?” said Edwards.
“People are wrapping them in tinfoil and hiding them,” she added. “People are testing at work. People who are trying to get pregnant are sometimes upset by the amount of tests that end up in trash cans.”
Lia’s test uses the same method for checking pregnancy as a plastic at-home test by measuring the hormone called human chorionic gonadotropin (hCG) in urine. And to get the FDA’s official clearance for medical devices, the company’s biodegradable version needed to be as accurate as existing models.
It’s made by sandwiching the diagnostic test strip between two layers of dense paper. Edwards and Simpson developed a stamplike tool that gives one end ridges that encourage liquid to bead, while the other has a quilted pattern to absorb a urine sample. Edwards said sourcing the fibers also proved to be a challenge because the paper industry doesn’t usually accommodate the strict guidelines of the FDA.
“We need really clean paper,” Edwards said.
Edwards and Simpson made 6,000 samples in their Center City office, and they partnered with Planned Parenthood to help test them.
“There’s no contract manufacturer where I can just show up on their doorstep and say, ‘Hey, make me a flushable pregnancy test,’ ” said Edwards with a laugh. “It doesn’t quite work that way because we’re bringing techniques from the paper and textile industry and mixing them with techniques from the diagnostic industry.”
The FDA study found Lia Diagnostics’ flushable pregnancy test can be stored at higher temperatures than plastic ones, which is useful in markets without air conditioning. And once the results appear — the classic two blue lines for “pregnant,” one line for “not pregnant” — they will not eventually dissolve like they do in other tests.
With FDA clearance and $50,000 won at TechCrunch’s Disrupt Berlin conference last month, Edwards said the next challenge is manufacturing to scale and keeping the cost down. The company estimates each test will cost between $9 and $22. They will be available for online purchase in mid-2018. The company plans to eventually move into stores and to expand its compostable techniques to other kinds of single-use diagnostic tools.
The flushable pregnancy test joins deodorant, the Steadicam, and the Slinky, inventions that all share origins in Philadelphia.
“Philly has been good to us,” said Edwards. But it’s still Philly: “People are like, ‘Oh a flushable pregnancy test, that’s such a great idea. That’s so easy, why hasn’t it been done before?’”
“Because it’s kind of hard.”