Avant Diagnostics, an innovator in molecular diagnostics,
this morning announced the start of calibration testing in preparation for the
company’s validation study of OvaDx®, which will be used to support a
pre-submission package to the United States Food and Drug Administration
(“FDA”). Avant expects to complete the calibration testing within 30 days.
OvaDx® is a sophisticated microarray-based test proposed for
use in monitoring women previously diagnosed with ovarian cancer. Pre-clinical
research studies with OvaDx® indicate high sensitivity and specificity for all
types and stages of ovarian cancer.
Upon completion of the testing, Avant said it intends to
test the previously purchased set of ovarian cancer specimens, including serial
sets obtained from women previously diagnosed with ovarian cancer, which will
serve as the validation study and form the basis of the pre-submission package
that will be submitted to FDA for review and comment prior to the commencement
of the OvaDx® 510(k) trial.
The validation study and 510(k) trial will be conducted in a
double-blinded environment supervised by independent clinical research
organization DOCRO, Inc. Validation study results are expected to be published
in a peer-reviewed scientific journal within six months of test completion and
data analysis.
“The entire Avant team has been working tirelessly over the
past few months to reach this critical milestone. We look forward to
communicating to our shareholders and the markets as we move through the FDA
negotiations and review of our 510(k) submission,” Gregg Linn, Avant’s CEO and
president stated in the news release.
For more information, visit
https://avantdiagnostics.wordpress.com/
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