(Refiling to fix typo in 4th paragraph word "presence")
By Susan Kelly
CHICAGO May 12 Quest Diagnostics Inc (DGX.N)
has developed the first commercially available test to identify
U.S. patients infected with the new H1N1 flu virus, the medical
testing provider said on Tuesday.
Quest said its Focus Diagnostics infectious disease
reference laboratory validated the test using specimens
confirmed as positive for the new virus by public health
authorities. The test does not need to be approved by the U.S.
Food and Drug Administration, the company said.
The virus, commonly referred to as swine flu, is a subtype
of Influenza virus Type A. The Focus Diagnostics test detects
the presence of Influenza A virus RNA and specifically
identifies the presence of the novel H1N1 virus, Quest said.
The test can detect the presence of a virus' RNA from a
patient's nasal or nasopharyngeal specimen. Quest said Focus
Diagnostics will perform the new test at its reference
laboratory in Cypress, California.
"The public health laboratories don't have the capacity to
do all the testing that is being requested. Now, clinicians and
hospitals have another way to potentially identify this novel
virus from patients by sending tests to us," said Dr. Jay
Lieberman, medical director of Focus Diagnostics.
"We are very confident that the test will accurately
identify this novel H1N1 strain," Lieberman told Reuters.
The tests, which list for $300, can be ordered directly
from Focus Diagnostics or through the Quest Diagnostics
national laboratory network, Quest said.
The Focus Diagnosics laboratory is expected to report back
on the test results within 24 hours of receiving a specimen.
Quest said it also would submit positive specimens and test
results to the appropriate public health authorities, as
required by local public health guidelines.
(Reporting by Susan Kelly, editing by Leslie Gevirtz)