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.
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 stamp-like 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.
Edwards and Simpson made 6,000 samples in their Center City office, and they partnered with Planned Parenthood to help test them. 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.
An experimental blood test accurately identifies people who do, or don’t, have celiac disease, even if they are following gluten-free diets, researchers say. The two main blood tests used to screen for celiac disease rely on detecting an immune response to gluten, but that immune response gradually disappears in people who avoid gluten.
"Unfortunately, many persons with gluten sensitivity go gluten-free without consulting their clinician for exclusion of celiac disease," said lead study author Dr. Vikas K. Sarna’s from Oslo University Hospital in Norway. "In such cases, guidelines recommend . . . performing a gluten challenge involving daily consumption of gluten for up to 8 weeks, followed by an endoscopic procedure for a biopsy taken from the small intestine (duodenum). Our blood test may replace such a gluten challenge and duodenal biopsy."
The new test is designed to detect immune cells in a blood sample that are specifically targeted at gluten proteins, even when the individual hasn’t been recently exposed to gluten. Sarna’s team tried their test on 62 patients with celiac disease and 19 individuals without celiac disease who were on a gluten-free diet, 10 patients with celiac disease who were eating foods containing gluten and 52 healthy individuals following normal diets. They also used the currently available celiac tests on these participants for comparison.
The old tests detected celiac disease in 9 out of 10 patients who weren’t on a gluten-free diet. But the old tests identified celiac disease in only 4 of the 62 patients who’d been following a gluten-free diet.
The new test, by comparison, was 96 percent accurate in distinguishing celiac disease patients from people who didn’t have celiac disease but were still following gluten-free diets. It was 95 percent accurate for distinguishing celiac disease patients who were eating gluten-containing foods from healthy individuals following normal diets, the researchers report in Gastroenterology.
"We calculated that our test is stronger to exclude rather than confirm the diagnosis of celiac disease in gluten sensitive persons," Sarna said. "Although we need more research in this field, we propose that the test be used to exclude celiac disease in persons on a gluten-free diet," he told Reuters Health by email.
"It is important to point out that this test is still not available for commercial use, although there is a huge demand of a test for celiac disease that can be applied for persons that are already on a gluten-free diet," Sarna said. "I do hope that the promising results from our study can initiate commercial initiatives along with more research, to allow this test to be used in the general public in the near future."
Several members of the research team have applied for a patent on this testing technology, and some disclose that they are consultants for companies. The clinical trial in the current study was paid for by the Research Council of Norway, the authors note.