What a week for Lia Diagnostics, the Philly-based start-up behind the first flushable, biodegradable home pregnancy test.
On Monday, the Food and Drug Administration blessed the Lia test with 510(k) class 2 clearance, approving it for over-the-counter sales.
Just hours later, lead developers won first place at TechCrunch Disrupt Berlin, beating out 15 other companies in a Startup Battlefield pitch competition and claiming a check for 42,000 euros – close to $50,000.
Also on Tuesday, Lia launched a "giving back" campaign – a fund- and publicity-raising program encouraging supporters to donate Lia tests (at $10 a piece) to women's health organizations including Planned Parenthood, Washington, DC.'s Whitman-Walker Health community health center, Quebec-based SOS Grossesse, and Philadelphia-founded PreserveFertility.org.
This twofold pitch for early sales is geared to "help us support reproductive health" and "allow us to invest in manufacturing, further reducing the cost and allowing us to get Lia in the hands of women everywhere, including you," touted company postings at meetlia.com.
Lia was spawned in 2015 by Bethany Edwards and Anna Simpson as grad students in the University of Pennsylvania's cross-disciplinary (engineering and applied science, business, design) Integrated Product Design program, with their cause boosted by early seed funding from Dreamit Ventures and Ben Franklin Technology Partners. It now has eight employees and expects sales to begin in earnest by mid-2018.
With good reason, Edwards hailed the FDA clearance Tuesday as "a milestone, achieved in less than two years from concept to efficacious product." And with 30 patents secured.
Designed to be far more discreet and eco-friendly than the average at-home pregnancy test, the paper-based Lia is ultra thin and lightweight, dispersing in water and biodegrading in soil. Yet it offers the same test for hCG — the presence of pregnancy-marking Human Chorionic Gonadotropin in urine – with the same success level as current market competitors.
"So the standard is over 99 percent accurate," said Anna Simpson during a TechCrunch Berlin Q&A session. "To date in our testing we've had 100 percent sensitivity and 100 percent specificity. So there's no false positives, no false negatives, in the lab and in our user studies."
Edwards then cautioned that "the FDA does not allow you to state that, because it's possible, you could eventually get one" – a false positive.
Plastic-packaged home tests "add two million pounds of plastic every year to landfills," she said.
The discreet use and disposing of a paper-based, flushable wipe test has proven a "really big factor" with product beta testers, Edwards added, with "92 percent telling us they would purchase it again, and 79 percent saying they would purchase it over others. . . . For woman who are testing frequently, who're trying to get pregnant, they have trouble hiding the pile-up of tests in the trash. There's a stigma for women who are struggling with getting pregnant," which becomes even more of an issue "when [tests are] used at work."
The global market for at-home pregnancy and ovulation tests is currently "over $900 million and expected to exceed $1 billion by 2020," said Edwards. "There are three big legacy devices, three main players in the U.S. in terms of brands" — First Response, ClearBlue, and Ept — "plus a large number of generic tests, made in China."