In the developed world, routine monitoring of liver function for patients is the standard of care. Monitoring for liver toxicity in the developing world, however, is severely limited by expense and access to modern instrumentation. While increased access to therapies is encouraging, a number of medications are known to exhibit substantial liver toxicity in patients, resulting in debilitating symptoms and even death in the most severe cases.
To address these obstacles and to make liver function testing a standard of care worldwide, DFA has developed a low-cost, patterned paper-based, liver enzyme diagnostic test that can provide an assessment of liver health from a single drop of blood in about 15 minutes. The DFA liver function test (LFT) could provide invaluable information to healthcare providers in rural settings and could have a dramatic impact on patient care in the developing world.
DFA has completed the relevant laboratory and field studies to demonstrate the liver function test's effective use in a low-resource setting, has gained Class I exempt status for its LFT-ALT testing system, obtained FDA Establishment Registration, and is in the process of preparing to submit for regulatory approval for Point of Care Use. This test should have a dramatic impact on patient care in the developing world.