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First flushable pregnancy test gets pre-market approval from FDA

The U.S. Food and Drug Administration granted pre-market approval for Lia Diagnostics’ home pregnancy test last month. It marks the first pregnancy test made of a biodegradeable paper that can be flushed down a toilet. The pre-market approval process is granted to Class 3 medical devices submitted for scientific and regulatory review to evaluate safety and effectiveness.

Lia Diagnostics announced the news at TechCrunch Disrupt Berlin this week,according to TechCrunch.

Although Lia uses biodegradeable material and eschews the plastic components typically used in these devices, its test works in the same way, according to the company’s website. The test is designed to detect high levels of Human Chorionic Gonadotropin in urine, a hormone women produce when a fertilized egg attaches to the uterus.

CEO Bethany Edwards cofounded the company in 2015 with some fellow classmates in the Integrated Product Design program at the University of Pennsylvania —Anna Couturier and Frances DiMare. Although the biodegradeable nature of the test is a plus for the environment, other factors that motivated this approach were to create a discreet test that could ensure the user’s privacy. Ease of use was another goal.

The diagnostics startup counts Ben Franklin Technology Partners and Dreamit Health as investors. It is currently part of the Digital Health Accelerator at the University City Science Center in Philadelphia. Participants in the 12-month program receive $50,000 without having to give up equity. Earlier this year it was selected for a year-long program with Springboard Health Innovation Hub for Life Science companies.

Shannon Leaf, COO of the business, confirmed in a direct message that the diagnostics startup plans to sell the test to consumers starting in the middle of 2018. Although the biodegradeable pregnancy test will be available on LIA’s website, it will also be sold on Amazon, according to the TechCrunch article.

The price is in line with rival test kits, Leaf said. Customers can also make a donation to cover the costs of tests for other women.

There’s been a lot of interest in diagnostic tests associated with pregnancy but frequently it has been more involved with genetic screening to assess whether would-be parents possess a gene that would increase the risk of unintentionally passing along a harmful genetic condition, such as Natera, Counsyl, and others. But Lia Diagnostics founders contend that there hasn’t been any significant innovation in the pregnancy testing space for more than 30 years.

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Kristen Fitch

Kristen Fitch

Senior Director, Marketing