FDA approved a hepatitis C virus quantitative RNA test to be used as an aid in the diagnosis of HCV infection for certain patient populations.
Results
from the COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0, developed by
Roche, can now be used to confirm an active hepatitis infection, in
addition to providing an accurate measurement of how much virus is in a
patient’s blood, to help a physician determine the best course of
treatment.
The
test is the first quantitative HCV RNA test to be approved for use as
an aid in diagnosis for active HCV infection. This expanded indication
is in addition to its approved use as a viral load test to help
physicians assess a patient’s response to antiviral therapy. Roche HCV
viral load tests have also been used to establish the treatment efficacy
of direct-acting antiviral treatment regimens recently approved by the
FDA.
The
dual-probe PCR assay is intended for use in the management of patients
with chronic HCV, in conjunction with clinical and laboratory markers of
infection, and as an aid in diagnosis for individuals with antibody
evidence of HCV infection with evidence of liver disease, individuals
suspected to be actively infected with HCV antibody evidence, and
individuals at risk for HCV infection with antibodies to HCV. Detection
of HCV RNA indicates that the virus is replicating and therefore is
evidence of active infection.
The
test is an in vitro nucleic acid amplification test for the detection
and quantitation of hepatitis C virus RNA genotypes 1 to 6 in human EDTA
plasma or serum. It can be used to predict the probability of sustained
virologic response early during a course of antiviral therapy and to
assess viral response to antiviral treatment, as measured by changes of
HCV RNA levels.
The University of Pennsylvania and Genisphere LLC formed a collaborative research agreement to
study targeted nanotherapeutics. The collaboration between Genisphere,
provider of the 3DNA drug delivery platform, and UPenn’s Theresa Busch,
will utilize a breast cancer model to study photodynamic therapy.
Photosensitizing
drugs are administered to patients prior to surgery, and then activated
by visible light after the tumor tissue is removed, to destroy
cancerous cells left behind. The delivery of PDT to the entire surgical
field is essential, thus selective photosensitizer accumulation in
diseased cells is necessary to avoid therapy-limiting damage to normal
tissues.
“When
used in the intraoperative setting, PDT provides for local treatment at
the site of surgery and can be effective in eradicating undetected or
unresectable tumor,” said Busch, a research associate professor of
radiation oncology. “This concept is suggested by patient outcomes in
our previous clinical trials of intraoperative PDT for malignant pleural
mesothelioma, and we are currently conducting a randomized phase II
clinical trial for this indication.
“This
approach can be adapted for intraoperative PDT of breast cancer;
however, the addition of a photosensitizer that is targeted to breast
cancer cells could broaden the therapeutic window and selectively
increase cytotoxic effect.”
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