[Congressional Record (Bound Edition), Volume 158 (2012), Part 5]
[Extensions of Remarks]
[Page 7466]
[From the U.S. Government Publishing Office, www.gpo.gov]




      COMMENDING A MAJOR ADVANCEMENT IN THE FIGHT AGAINST HIV/AIDS

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                          HON. CHARLES W. DENT

                            of pennsylvania

                    in the house of representatives

                          Friday, May 18, 2012

  Mr. DENT. Mr. Speaker, I am pleased to advise my colleagues of an 
important decision issued earlier this week by the Food and Drug 
Administration's (FDA) Blood Products Advisory Committee (BPAC) that 
will revolutionize HIV testing and the fight against AIDS. The 17-
member advisory panel unanimously recommended approval of the first 
over-the-counter HIV test. The OraQuick In-Home HIV test detects the 
presence of HIV antibodies in roughly 20 minutes after a simple oral 
swab.
  OraSure Technologies, a company in my congressional district, has 
been at the forefront of HIV/AIDS diagnostics for over a decade. If the 
FDA follows the recommendation of the advisory panel and approves 
OraSure's In-Home HIV test, it will be the first oral fluid rapid test 
made commercially available over-the-counter.
  BPAC's decision represents a significant milestone in the nation's 
fight against the HIV/AIDS epidemic. Disease status awareness enables 
individuals to protect their health and the health of others. Over-the-
counter testing will provide an option for individuals to get tested in 
the privacy of their own home and importantly, is expected to reach 
traditionally underserved communities. According to an FDA analysis, 
the OraQuick test is predicted to lead to 45,000 new positive HIV/AIDS 
diagnoses and avert more than 4,000 HIV transmissions within the first 
year of deployment.
  Nearly 50,000 Americans become infected with HIV each year and some 
240,000 are unaware of their status. The availability of an over-the-
counter test will lead to greater testing, increased diagnoses, reduced 
transmissions, earlier treatment and saved lives.
  It is my honor to commend OraSure in leading the way in transforming 
diagnostic testing through innovative new technologies, and I am proud 
of the company's dedication and accomplishments in making HIV/AIDS 
testing more accessible.

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