Avant Diagnostics, Inc. (AVDX) Aims to Provide Early Detecti Avant Diagnostics, Inc. (AVDX) Aims to Provide Early Detection Solutions for Better Treatment Options
Avant Diagnostics, Inc. is a company that focuses on the commercialization of proprietary microarray-based tests for the early detection of cancers, neurodegenerative diseases, and more. The company’s leading product is OvaDx®, a non-invasive pre-screening test that detects ovarian cancer by measuring the activation of the immune system in blood samples in response to early stage ovarian tumor cell development. This is the market’s first large panel screening test designed to detect ovarian cancer early. With early detection, more treatment options become available for patients that should delay or prevent disease progression. OvaDx® would be an optional supplement to existing tests such as CA-125, OVA1, and transvaginal ultrasounds.
In October 2015, Avant Diagnostics received a notice that its previously purchased specimens had been approved to use in the upcoming validation study to support a pre-Submission package to the United States Food and Drug Administration (FDA). The company intends to start the FDA validation study shortly after completing calibration testing. Once that process is finalized, Avant Diagnostics will test the approved specimens as a basis for the submission package. The company hopes its innovative product can then begin its 510(k) trial.
In a news release, Gregg Linn, Avant’s chief executive officer and president, stated, “Avant continues to make steady progress towards its goal of obtaining FDA 510(k) clearance for OvaDx®. We intend to periodically communicate with our shareholders and markets as we progress through the FDA negotiations and through FDA’s review of our 510(k) submission.”
According to the American Cancer Society, 21,290 women are expected to be diagnosed with ovarian cancer in 2015 alone. Adding to that number are 14,180 deaths from the disease. Furthermore, 1 in 75 women are at risk for this disease, which is the fifth leading cause of female cancer deaths.
By developing effective pre-screening tests, like OvaDx®, Avant Diagnostics aims to greatly improve the quality of life among patients by giving them the opportunity for early treatment options.
For more information, visit www.avantdiagnostics.com
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