Avant Diagnostics, Inc. (AVDX) Leading the Next Advance in t Avant Diagnostics, Inc. (AVDX) Leading the Next Advance in the ‘War on Cancer’ through the Development of OvaDx®
The American Cancer Society estimates that about 21,290 new cases of ovarian cancer will be diagnosed in 2015, and roughly 14,180 women will die from the illness within the United States. These figures outline the severity of ovarian cancer, which is currently the eighth most common cancer among women, as well as the fifth leading cause of cancer-related death among women, according to data from SEER. Over the past forty years, mortality rates for ovarian cancer have recorded a mild decline as a result of the ongoing ‘War on Cancer’, but these improvements pale in comparison to the progress made on some other forms of the disease. Today, nearly half of all cancer patients can expect to live for five or more years after diagnosis with proper treatment.
With this data in mind, the question regarding ovarian cancer becomes clear: Why hasn’t more progress been made toward improving survivability? To understand the answer to this question, one needs to take a closer look at the illness.
Ovarian cancer begins when healthy cells in an ovary mutate and begin to grow uncontrollably, forming a mass known as a tumor. Tumors come in two basic forms – cancerous and benign. While benign tumors can cause problems by continuing to grow, cancerous tumors are, by far, the more dangerous form. Cancerous tumors on the ovaries are malignant, meaning they can continue to grow and spread to other parts of the body. For this reason, catching the disease in its early stages is paramount to improving survivability rates.
When diagnosed early, ovarian cancer is actually an extremely survivable disease. According to data from the American Cancer Society, individuals with ovarian cancer that’s diagnosed in stage I boast a five-year survivability rate of approximately 90 percent. However, this outlook is significantly worse when the illness isn’t discovered until the later stages. In stage II, the five-year survivability rate for invasive epithelial ovarian cancer, which accounts for roughly 85 percent of all cancers of the ovaries, falls to 70 percent. In stage III, survivability is just 39 percent.
With the importance of early detection clearly illustrated, a massively underserved indication within the diagnostic market becomes evident. The National Ovarian Cancer Coalition reports that almost 70 percent of women diagnosed with the common epithelial ovarian cancer are not diagnosed until the disease is advanced in stage.
Current ovarian cancer detection methods are hampered by a variety of factors. The simplest check, a pelvic exam, consists of a health care professional feeling the ovaries and uterus for size, shape and consistency. While these tests are relatively effective for some reproductive system cancers, most early ovarian tumors are difficult or impossible for even the most skilled examiner to feel. Screening tests and exams are also used for detection in people who don’t display any symptoms. However, both transvaginal ultrasound (TVUS) and the CA-125 blood test have drawbacks.
In the case of TVUS, sound waves are used to study the reproductive system. These waves can help physicians locate tumors on the ovaries, but they doesn’t help determine if the mass is cancerous or benign. The CA-125 blood test, on the other hand, checks the patient’s blood for high levels of the CA-125 protein, which is commonly associated with ovarian cancer. The effectiveness of this test is also hindered, because many common conditions other than cancer can cause high levels of CA-125.
Avant Diagnostics, Inc. (OTCQB: AVDX) is developing a novel approach to ovarian cancer screening that has the potential to fill this underserved need in the medical community. 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 research, OvaDX has displayed 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. Following FDA approval, Avant plans to market OvaDx to doctors as a supplement to existing tests for women seeking greater wellness, as well as those in the elevated risk category for ovarian cancer.
As of its latest update, Avant had received FDA approval for ovarian cancer specimens to be used in a forthcoming validation study to support a pre-submission package to the FDA. After this package is submitted and reviewed, the company will look to commence the OvaDx 510(k) trial, which it plans to conduct in a double-blinded environment supervised by an independent clinical research organization.
For more information, visit www.avantdiagnostics.com
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