The biotechnology industry is as exciting in 2013 as it ever has been before, providing investors opportunities to be a part of a paradigm shift that exploits decades of research that are now cornerstones for building game-changing therapies. One of the most intriguing propositions today is that of genomics, an industry that is gaining traction in the medical space in recent years. Ten years after the completion of the Human Genome Project, the decreasing costs associated with mapping and molecular diagnostics are shepherding increasing acceptance and usage, uniquely positioning Arrayit Corporation (ARYC) for growth amid larger peers like Exact Sciences Corp. (NASDAQ:EXAS) and Myriad Genetics, Inc. (MYGN), especially with Arrayit’s focus on diagnostics for ovarian cancer as part of their larger portfolio of offerings.
Experts Speak Out on the Future of Genomics
Speaking at the recent FutureMed conference at Singularity University, synthetic biology expert for Autodesk’s (NASDAQ:ADSK) Bio/Nano Programmable Group Andrew Hessel defined the growth potential for genomics when he said that the 21st century is to biology as the 20th century was to information technology. Echoing that sentiment, research firm Companies and Markets predicted that the molecular diagnostics market will grow to $8.1 billion in 2017 from $4.8 billion in 2011.
The Ovarian Cancer Challenge
Ovarian cancer is the fifth leading cause of cancer among women in the United States and the leading cause of female reproductive cancer deaths. The National Cancer Institute estimated that 22,280 women will be diagnosed with ovarian cancer in 2012 and more than 15,000 deaths will occur during the year because of the disease. These high diagnosis and mortality rates carry cost in excess of $5.1 billion annually.
One of the problems is that today’s therapies are most effective when ovarian cancer is detected early. This difference between diagnosis at Stage 1A versus Stage 4 is striking. Nearly all Stage 1A patients can be cured and even 93 percent of Stage 1B patients survive more than five years. However, 82 out of every 100 patients diagnosed at Stage 4 die within five years.
While there have been advancements in therapeutics, the answer to this “silent killer” resides within screening and early detection.
Arrayit’s OvaDx® pre-symptomatic ovarian screening cancer test provides this type of solution.
Tried, True and Fast Results
Based on more than a decade of research and development, Arrayit’s patented proteomic approach tests about 100 markers in parallel, identifying genetic and physiological causes by exploiting the immune system for early detection of ovarian cancer.
Research has documented an amazing accuracy rate and the digital testing can be done with only a few drops of blood to deliver a definitive “yes” or “no” answer.
Arrayit has refined the process for nearly immediate results. Within 150 minutes, a tiny amount of patient’s serum is mixed with the OvaDx reaction buffer to create a sample that reacts with the OvaDx microarray, leading to biomarker binding that is then washed, scanned and quantified to generate the test result.
Research data conducted using 188 serum samples across seven different ovarian subtypes from varying stages of the disease showed 100 percent specificity and 79.7 percent combined sensitivity.
Great for Cancer Patients, Great for Shareholders
The revenue potential from OvaDx® for Arrayit is incredible for a company that posted a small net profit in the third quarter of 2012 and yet still maintains a modest market capitalization of $3.85 million.
It does not seem an exaggeration to say that the OvaDx® test would deliver a substantial benefit to ovarian cancer patients and to the nation by reducing costs in the healthcare system. Extrapolating information from the NCI and others, nearly 10 percent of adult women in the U.S. run an elevated risk of ovarian cancer and should be tested every five years, meaning that approximately 1.5 million tests should be conducted annually. At a $650-per-test price point, sales would total $975 million annually for Arrayit.
$975 million in testing could potentially reduce ovarian cancer deaths by more about 80 percent (based upon cumulative specificity modeling as noted above), meaning that running a 2.5-hour OvaDx® screen could save about 12,000 women’s lives each year and more than $3.1 billion in associated healthcare costs.
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