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at-home testing

Flu Finder Wins 2nd Place in UW Business Plan Competition

Carly Holstein
23 May 2014

Based on their thesis research in the Yager Lab, PhD candidates Carly Holstein and Gina Fridley teamed up with MBA candidates Alyssa Hochman, Jonny Holz, and Joel Loveday to develop a business plan for the Flu Finder diagnostic test. Flu Finder is a paper-based assay that aims to improve upon current flu diagnostics by providing a test that is accurate, inexpensive, and can be administered by anyone, anywhere, with results in less than 20 minutes. Flu Finder is envisioned to start as an improved test for use in the doctor's office, but aims to eventually be sold over the counter for use by the patient at home. The team competed in the University of Washington Business Plan Competition and placed 2nd out of 92 teams from across the state. Flu Finder also took home the Best Innovation prize. For the full story from the UW Department of Bioengineering, click here.

The Flu Finder team poses with their second place prize in the UW Business Plan Competition. From left to right: Carly Holstein (PhD candidate, Bioengineering), Alyssa Hochman (MBA candidate), Joel Loveday (MBA candidate), Gina Fridley (PhD candidate, Bioengineering), and Jonny Holz (MBA candidate).

FDA Approves the First At-Home HIV Diagnostic Test

Carly Holstein
17 July 2012

Earlier this month, the FDA announced its approval of the first over-the-counter, rapid HIV test for at-home use. The test, OraSure's OraQuick In-Home HIV Test, allows users to test their own saliva for the presence of anti-HIV antibodies, using a rapid test strip that provides a result in 20-40 minutes.

The decision to approve this test was a controversial one, given the many questions surrounding at-home testing and the ~3-month window period that exists between HIV transmission and the development of anti-HIV antibodies. However, following the recommendation of its panel, the FDA decided that the benefits of at-home HIV testing outweighed the risks. In particular, this decision was largely motivated by the fact that nearly 20% of the 1.2 million people living with HIV in the United States are unaware of their status (see the CDC's fact sheet). By increasing access to HIV testing, it is hoped that this test will empower more people to know their HIV status so they can get the treatment they need and help prevent the spread of the virus.

This approval represents a breakthrough not only for the fight against HIV, but also for at-home testing in general. Although the FDA has approved many over-the-counter tests for at-home use in the past--including tests for pregnancy, glucose/diabetes monitoring, and drugs of abuse--this OraQuick In-Home HIV Test represents the first ever approved test for an infectious disease. As a developer of point-of-care diagnostics, this approval is extremely exciting, as it sets a precedent for the approval of at-home diagnostic tests. Now the question is, which test will be next??