Avant Diagnostics, Inc. has commenced calibration testing of
OvaDx®, a sophisticated microarray-based test that measures the activation of
the immune system in blood samples in response to ovarian tumor cell
development. In a recent news release, the company indicated that it expects to
complete this calibration testing later this month, allowing it to move forward
with validation testing while forming the basis of the pre-submission package
that will be delivered to the U.S. Food and Drug Administration for review and
comment prior to the commencement of the OvaDx® 510(k) trial.
“The entire Avant team has been working tirelessly over the
past few months to reach this critical milestone,” Gregg Linn, president and
chief executive officer of Avant, stated in a news release. “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.”
According to the American Cancer Society, ovarian cancer
currently ranks fifth in cancer deaths among women, accounting for more
fatalities than any other cancer of the female reproductive system. For this
reason, biopharmaceutical firms are currently scrambling to address the
underserved indication. Endocyte (NASDAQ: ECYT) is developing a novel form of
chemotherapy that targets a key receptor found in virtually all ovarian
cancers, but the best defense against this debilitating disease is early
diagnosis. While patients diagnosed in Stage I demonstrate a 90 percent
five-year survival rate, this survivability rapidly decreases with later
diagnosis. If diagnosed in Phase III, patients’ relative five-year survival
rate drops to just 39 percent.
Through the development of OvaDx, Avant will look to greatly
improve upon the detectability of ovarian cancer in high-risk patients. In
preclinical studies, the product has shown the capability to detect stage IA
markers with approximately 80 percent sensitivity while providing definitive,
real-time results.
As Avant continues to progress toward the market approval of
its innovative large panel screening test for ovarian cancer, the company is in
a favorable position to promote sustainable growth in the years to come. For
prospective shareholders, Avant’s recent progress toward the initiation of its
validation study of OvaDx makes it an intriguing investment opportunity moving
forward.
For more information, visit www.avantdiagnostics.com
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