The laboratory testing market is huge. According to a study conducted by Quest Diagnostics, the largest clinical testing laboratory in the U.S., the laboratory testing market in the United States is approximately $50 billion. Of that, 60% is controlled by hospital-based laboratories. Another 35% of the market is held by independent clinical laboratories, and physician office laboratories (POLs) hold the remaining 5%. Within this $50 billion market, most of the testing performed is for routine lab tests (such as total cholesterol, pap testing and white blood cell count) and anatomic pathology tests. Anatomic pathology tests attempt to identify abnormalities in body organs that signal the advent of disease as opposed to the more routine procedures that test blood and other bodily fluids. However, recently there has been a dramatic increase in gene-based testing and molecular testing, which measure our susceptibilities to inherited diseases, and esoteric testing. Esoteric testing is a catchall term for more complex clinical tests.
In the vanguard of the forces advancing women’s health through these technologies marches Avant Diagnostics, Inc. (OTCQB: AVDX). Employing technology it has exclusively licensed from Wayne State University, the company has developed a microarray-based diagnostic test called OvaDx. OvaDx is the first large panel biomarker monitoring test for ovarian cancer. It measures the activation of the immune system in blood samples in response to early stage ovarian tumor cell development. A biomarker is simply an objective measure of the body’s functioning.
Microarrays have been described as the tracks of the global life sciences freight train. A microarray is a collection of DNA on a surface. They are sometimes referred to as biochips or DNA chips. In the forefront of microarray technology is the Arrayit Corporation (OTC: ARYC), and back in 2009, Avant entered into a Technology Transfer Agreement (TTA) with Arrayit. The TTA gave Avant exclusive license rights to all of Arrayit’s trade secrets and protocols required for the sale and use of the OvaDx ovarian cancer test. Arrayit Corporation is a leader in the microarray industry. It develops, manufactures and markets life science tools and integrated laboratory platforms for the analysis of genetic variation, biological function, and diagnostics. Arrayit also provides specialized equipment, tools, and microarray manufacturing services to more than 10,000 research laboratories, pharmaceutical companies, academic institutions, clinical research organizations, government agencies and biotechnology companies around the globe.
Microarrays have indeed proved to be a track to success, and at least three companies, Illumina, Inc. (NASDAQ: ILMN), Agilent Technologies, Inc. (NYSE: A) and Myriad Genetics, Inc. (NASDAQ: MYGN) have taken that track. Myriad deserves special mention. The company’s valuation rose spectacularly after it was revealed that Angelina Jolie had used Myriad’s diagnostic test, BRACAnalysis. BRACAnalysis determined that Jolie had an 87 percent risk of breast cancer and 50 percent chance of ovarian cancer because of an inherent genetic mutation. Miss Jolie has a defect in her BRACI genes. Those with a similar defect have, on average, a 65% chance of developing breast cancer. Myriad got its microarray technology from Arrayit, the same company that has given Avant access to its methodologies.
Avant is in the right place at the right time. The molecular diagnostics segment of the laboratory testing market is expected to reach $8 billion by the end of 2017. OvaDx will soon undergo 510(K) trials. A 510(K) is a pre-market submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device. Avant believes the OvaDx test has an advantage over Roche’s CA-125 test and Vermillion’s Ova 1 test. With its gene-based microarray OvaDX test, Avant is not only guarding our womenfolk, it’s poised to enjoy great financial success. It’s a classic case of having your cake and eating it, too.
For more information, visit www.avantdiagnostics.com
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