Avant Diagnostics, Inc. (AVDX) Advancing Development of OvaDx® through Ongoing Calibration Testing
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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