October is international breast cancer awareness month, but
it’s also a great time to take a look at the effects that other types of cancer
have on the global population. Each year, over 20,000 women in the United
States are diagnosed with ovarian cancer, and more than 14,000 women die from
the devastating disease. According to the Centers for Disease Control and
Prevention, despite accounting for just three percent of all cancers in women,
ovarian cancer causes more deaths than any other cancer of the female
reproductive system.
The key to surviving ovarian cancer, according to the
National Cancer Institute, is early detection. When discovered in a localized
stage, current treatment options enable a five-year survivability rate in
excess of 92 percent. However, when ovarian cancer remains undiagnosed until
the distant stages, which feature cancer on one or both ovaries as well as distant
metastases on the liver or lungs, five-year survivability falls to less than 22
percent.
Avant Diagnostics, through the development of OvaDx®, is
preparing to make diagnosis of early-stage, pre-symptomatic ovarian cancer
faster than ever before. OvaDx is a sophisticated microarray-based test that
measures the activation of the immune system in blood samples in response to
early-stage ovarian tumor cell development. In clinical trials, Avant’s
proprietary diagnostic technology has indicated high sensitivity and
specificity for all types and stages of ovarian cancer – including stage IA-IV
borderline serous, clear cell, endometrioid, mixed epithelial, mucinous, serous
and ovarian adenocarcinoma.
Earlier this month, the company took a significant step
toward achieving regulatory approval for OvaDx when it announced that it had
secured ovarian cancer validation test specimens for use in its forthcoming
validation study. The results of this study will be used to support Avant’s
pre-submission package to the United States Food and Drug Administration, which
will be submitted prior to the commencement of the company’s pivotal OvaDx
510(k) trial.
“Avant continues to make steady progress toward its goal of
obtaining FDA 510(k) clearance for OvaDx,” Gregg Linn, president and chief
executive officer of Avant, stated in a news release. “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.”
When approved, Avant intends to market OvaDx as both an aid
in monitoring women previously diagnosed with ovarian cancer and an elective
screen for women seeking greater wellness. Through these efforts, the company
has an opportunity to greatly improve the survivability of this deadly disease
while simultaneously promoting sustainable financial growth in the competitive
biopharmaceutical industry.
For more information, visit www.avantdiagnostics.com
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