Avant Diagnostics, Inc. (AVDX) Preparing to Commen
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Posted On: 10/21/2015 4:31:49 PM
Avant Diagnostics, Inc. (AVDX) Preparing to Commence Pivotal Validation Study for OvaDx®
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
Please see disclaimer on the QualityStocks website: http://Disclaimer.QualityStocks.com
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
Please see disclaimer on the QualityStocks website: http://Disclaimer.QualityStocks.com
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