By the yard: Diagnostics for All hopes to mass-produce its disposable paper test for liver damage on sheets.
Diagnostics for All currently runs on funding from philanthropic organizations and grants from the Gates Foundation. But the company is backed by a shrewd business plan. “Our twist on the nonprofit model is that we actively seek partnerships with for-profit companies in the developed world,” says Beattie. Once its technology is licensed, the company plans to collaborate with for-profit companies to market their technology closer home. “It [will give] us a degree of sustainability and the capability to try new tests without relying on grant funding,” Beattie said.
Once its tests have been established for the developing world, the company plans to begin distributing the liver function test for use in the United States, where it also has a market. “If it was easy to monitor for liver function, it could have some impact even here,” says Pollock.
This summer, Diagnostics for All will collaborate with Pollock at the Beth Israel Medical Center to calibrate and validate the test using a bank of discarded blood and serum samples which have already been analyzed. The paper test’s performance will be compared to standard methods used to detect the liver damage markers. Following the clinical sample tests, the company hopes to work with local organizations in Africa and South Asia to begin field tests within a few months. “We are expecting to be in lab testing using real human blood by this summer, field tests later this year, and full scale commercialization by 2012,” says the company’s CEO, Una Ryan. “Once we’ve shown the efficacy of our tests, we’ll apply for local regulatory approval, based on WHO guidelines.”
Bernhard Weigl, the director at the Center for Point-of-Care Diagnostics for Global Health, is optimistic about the results of clinical tests. “Clearly the liver function test is a critical component of anti-retroviral therapy–we’re excited about the idea,” he says. He hopes to begin collaborations with the team at the company soon to assess the test before it begins field tests.
Diagnostic for All hopes to expand the reach of its paper test to other diagnostics as well. Global health patterns could soon be monitored out using this cheap, disposable new test. “We basically intend to put as many known clinical chemistry tests, and as many known immunoassays onto our platform,” says Ryan, “The sky’s the limit.”