[Congressional Record (Bound Edition), Volume 158 (2012), Part 8]
[Extensions of Remarks]
[Page 11189]
[From the U.S. Government Publishing Office, www.gpo.gov]




     CONGRATULATING ORASURE TECHNOLOGIES FOR HIV/AIDS BREAKTHROUGH

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                          HON. CHARLES W. DENT

                            of pennsylvania

                    in the house of representatives

                        Wednesday, July 11, 2012

  Mr. DENT. Mr. Speaker, I am thrilled to draw attention to a landmark 
decision by the Food and Drug Administration (FDA) last week approving 
the OraQuick In-Home HIV test and commend OraSure Technologies for this 
profound advancement in HIV/AIDS diagnostics. This test is the first 
rapid over-the-counter HIV test approved in the United States. The 
OraQuick In-Home HIV test detects the presence of HIV antibodies 
roughly 20 minutes after a simple oral swab. It is also the first rapid 
diagnostic test for any infectious disease that has been approved by 
the FDA for sale over-the-counter.
  The FDA's decision is a significant moment in the history of our 
fight against HIV/AIDS. Since the beginning of the epidemic, getting 
individuals tested has been a critical component of HIV prevention and 
linkage to care. HIV testing enables individuals to know their status 
and protect their health as well as the health of others. Yet, over 1 
million Americans are unaware of their infection. Those who do not know 
they have HIV are disproportionately responsible for the nearly 50,000 
new infections that occur each year. The availability of an over-the-
counter test will lead to greater testing, increased diagnoses, reduced 
transmissions, earlier treatment and saved lives.
  OraSure Technologies, located in the heart of the Lehigh Valley in 
the 15th Congressional District of Pennsylvania, has been at the 
forefront of rapid diagnostics for over a decade. This most recent 
accomplishment comes on the heels of the company receiving approval for 
our nation's first rapid test for Hepatitis C. Headquartered in 
Bethlehem, PA, OraSure's innovation has led to an economic resurgence 
on a brownfield site where Bethlehem Steel once stood proud.
  Again, it is an honor to commend OraSure for leading the way in 
transforming diagnostic testing through innovative new technologies and 
playing a key role in what will hopefully be a transformation in the 
fight against HIV/AIDS. I want to extend my congratulations to the 
company and all of its employees for earning approval of the first 
over-the-counter in-home HIV test. This achievement will have a 
dramatic impact on the number of individuals who will learn their HIV 
status and most importantly, save countless lives.

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