Currently
there is substantial under-diagnosis of hepatitis C in the general population.
Of the estimated 4.1 million HCV-infected individuals in the US, more than half
are believed to be unaware of their infection. These individuals will contribute
to rising morbidity and mortality rates from HCV due to the development of progressive
liver disease.
OraSure reported this week the development of a prototype
assay for the detection of antibodies to hepatitis C virus (HCV) using their OraQuick
rapid test platform. A rapid, POC test for HCV has substantial application in
identifying infected individuals in public health clinics and other medical centers,
as well as in hospital settings and physician offices. Deployment of POC testing
may thus increase the amount of HCV diagnosis, allowing increased therapeutic
intervention and improved management of patient outcomes through lifestyle counseling.
This
test device has been developed for application with venous blood, finger-stick
blood, plasma, serum and oral fluid specimens. Following is the text of the OraSure
announcement about the development of this new test:
OraSure
Technologies Announces Pre-clinical Study Results for Prototype Rapid HCV Antibody
Test at AACC Annual Meeting
OraSure
Technologies, the market leader in fluid diagnostics, announced this week pre-clinical
study results for a prototype rapid Hepatitis C ("HCV") antibody test
on the Company's OraQuick® test platform, using oral fluid, finger-stick whole
blood, venous whole blood, serum and plasma samples. The study results were reported
by OraSure at the 2007 Annual Meeting of the American Association of Clinical
Chemistry held in San Diego, California.
In
pre-clinical studies conducted by the Company, performance of the prototype HCV
test for all specimen types was shown to be equivalent to or better than results
obtained from currently available, state of the art laboratory-based enzyme immunoassay
tests using serum and plasma specimens. Additional information regarding the preclinical
study results presented by OraSure at the ACC Annual Meeting can be found at www.orasure.com/aacc.
"We
are very pleased with the pre-clinical results generated by our prototype OraQuick®
rapid HCV antibody test," said Douglas A. Michels, President and CEO of OraSure
Technologies. "Our development efforts are proceeding on schedule, and we
intend to begin the final clinical studies required to obtain FDA approval during
the next several months. Our plan is to complete these studies as soon as possible
and file an application for FDA approval in early 2008. Assuming we are successful,
we expect that our test will be the first rapid HCV antibody test approved by
the FDA for use in the United States."
Prospective
pre-clinical testing of 419 low-risk human subjects using oral fluid, finger stick
and venous whole blood, serum and plasma, generated concordant results across
all specimen types for each individual. Specificity, which is the percentage of
tests that correctly show a negative result when an individual is not infected,
was 99.8% in all specimen types. Three individuals in this group were newly identified
as having been infected with HCV.
In
testing of 92 individuals known to be infected with HCV, pre-clinical results
indicated sensitivity in venous whole blood and oral fluid of 100%. In addition,
639 archived HCV-positive plasma samples were tested and similarly resulted in
100% sensitivity. Sensitivity is a measure of the percentage of tests that correctly
show a positive result when an individual is infected with HCV.
The
pre-clinical studies also evaluated the test's sensitivity during seroconversion.
Seroconversion refers to the period of time immediately after infection during
which an individual's body generates detectable antibodies to HCV. Out of 22 seroconversion
panels tested, the prototype HCV test detected HCV antibody on average three days
earlier than a laboratory-based assay and in no case did the prototype test detect
HCV antibody later than the laboratory assay.
About
Hepatitis C in the U.S.
Hepatitis
C is the most common blood-borne infection in America, affecting approximately
four million people or about one in every 50 adults, according to the Centers
for Disease Control and Prevention. Most people who contract the disease will
develop chronic hepatitis C infection and more than half of infected persons are
not aware that they have the disease. Chronic Hepatitis C can cause cirrhosis,
liver failure and liver cancer. About half of all cases of primary liver cancer
in the developed world are caused by Hepatitis C, and Hepatitis C related liver
disease is now the leading cause for liver transplants. Without increased therapeutic
treatment, the number of deaths from HCV infection is expected to increase substantially
over the next 10 to 20 years due to the progression of liver disease in the infected
population.
OraSure
Technologies. OraSure Technologies Announces Pre-clinical Study Results for Prototype
Rapid HCV Antibody Test at AACC Annual Meeting. Press Release. July 19,
2007.
