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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