NEW YORK, Jun 26 (Reuters Health) - A saliva-based, painless test for
hepatitis C could be available within about a year, according to two companies
that are working to develop the device.
Hepatitis C is a viral infection transmitted through contact with the blood
of an infected person, use of contaminated needles, or sex with an infected
partner. It can cause chronic or even life-threatening liver disease. Currently,
a blood test is used to screen for the virus.
According to the National Institutes of Allergies and Infectious Disease,
about 4 million people carry the hepatitis C virus in the US and about 120
million people are infected worldwide. Because the virus can be "silent" for up
to 20 years before symptoms develop, laboratory testing is often the only way to
identify the infection.
By eliminating the discomfort associated with blood tests, the test may help
to encourage screening for the hepatitis C virus, according to Beaverton,
Oregon-based diagnostics manufacturer Epitope, Inc. The new method also helps
eliminate the danger of healthcare workers picking up the virus through
needlestick injuries, the firm noted.
Epitope and LabOne of Lenexa, Kansas, hope to obtain US Food and Drug
Administration (FDA) approval for the product by next summer.
The test will be sold to public health institutions including hospitals,
clinics and community health centers. It will also be made available to drug
rehabilitation programs and AIDS treatment centers, both of which serve clients
with an elevated risk of contracting the hepatitis C virus, Epitope CFO Charles
E. Bergeron told Reuters Health.
While hepatitis C can lead to potentially fatal inflammation of the liver
and is "much more prevalent than HIV," there has not been "a real focus in
public health testing" for the virus, the executive noted. Epitope believes that
the availability of oral screening may cause a jump in testing levels similar to
the one that occurred when oral HIV tests came into use, Bergeron noted.
Like currently used blood tests, the oral screening test identifies the
presence of antibodies to the hepatitis C virus rather than the virus itself,
Bergeron stated. Because antibodies take time to develop, there can be a 6-month
"window" between infection and positive test results with either type of
screening, he added.
The new test will feature Epitope's OraSure oral fluid collection device,
which is already used in tests for HIV and drugs of abuse. A flat cotton swab
attached to a short tube is held between the gum and cheek for about 4 minutes,
and then is placed in a preservative-filled test-tube for delivery to the lab,
Bergeron explained.
Along with the saliva collection equipment, each kit will include
instructions for use, a return air-express mailer and a patient identification
form. Negative test results will be available to healthcare institutions within
about 24 hours, while positive results will take about 72 hours.
The new test could eventually be available to consumers for at-home use "but
it's not our focus right now," Bergeron said.
He noted that when Epitope first introduced its oral HIV tests, the company
expected the consumer market to be "a major focus." However, the firm decided to
sell the tests exclusively to healthcare institutions after discovering that the
over-the-counter market "wasn't as large as we thought it was," Bergeron said.
"Most people either wanted to go to a doctor or a clinic when dealing with
something serious," he explained.
