The molecular diagnostics industry is going through a flash point, with valuations being determined by Wall Street as new technologies are reshaping the landscape of the industry. The worldwide market for molecular testing was $3.7 billion in 2007 and is projected to hit $6.2 billion this year, demonstrating the tremendous annual growth as the health care space demands new diagnostic tools to improve outcomes and more efficiently detect and monitor diseases. A few companies — such as TrovaGene (NASDAQ:TROV), Exact Sciences Corp. (NASDAQ:EXAS), and Aethlon Medical Inc’s (OTCBB:AEMD) Exosome Sciences – are emerging with less invasive procedures that can open the door to new markets in molecular diagnostics and fill this area of great unmet medical need.
In short, it is all about biomarkers, measured genetic characteristics that may be used as an indicator of some biological state or condition. Each company is developing technologies that leverage proven biomarkers for different diseases, but employing a unique pathway to quantify the biomarker and what it means for the patient.
TrovaGene is focused on utilizing urine samples as the basis of its proprietary cell-free nucleic acid (cf-NA) technologies to develop tests for screening, detection, and monitoring of cancer, organ transplantation, infectious disease, and prenatal genetic testing. This month, the company made available its cell-free BRAF test, the first urine test for cancer mutation monitoring, at its Clinical Laboratory Improvement Amendments lab in San Diego, California. BRAF mutations are common in several types of cancer, particularly melanoma.
The launch presents TrovaGene with a significant opportunity to penetrate the melanoma market, considering that in about 40,000 of the 70,000 cases of melanoma diagnosed each year, the patient may be positive for BRAF V600E, a specific mutation of the BRAF gene. For melanoma, the key to treatment is early detection, as it is often treatable at early stages with many Food and Drug Administration-approved drugs. However, it is still the leading cause of skin cancer deaths annually because tumors often spread and the disease is not diagnosed early enough. For patients with biopsy-proven melanoma, the TrovaGene assay is now commercialized for monitoring the disease.
The approved test is the first of its kind for TrovaGene and paves the way for development of the rest of its pipeline. In addition to BRAF, the company is specifically focused on developing detection and monitoring assays for mutations in the KRAS and PIK3CA genes, which are often found in a bevy of cancers, including pancreatic, colorectal, lung, ovarian, breast, and endometrial cancers.
Exact Sciences has determined an efficient procedure to identify disease through another type of bodily waste, a stool sample. Similar to how TrovaGene uses the function of the kidney to pass cf-NA into urine, Exact Sciences utilizes cells being shed from the colon wall into the stool stream, including cells with altered DNA from polyps that can be the onset of colon cancer. In the test, branded Cologuard samples are collected and sent to the lab, where analysis searches to identify and isolate specific DNA biomarkers associated with cancerous and pre-cancerous conditions. If abnormalities are identified, then a patient will likely be referred by his physician for a colonoscopy to further assess for the presence of cancer.
In 2013, the National Cancer Institute estimates that about 102,000 new cases of colorectal cancer will be diagnosed and nearly 51,000 deaths will be attributed to the disease, making it the second leading cause of cancer deaths in the U.S. There are many approved drugs and drug combinations for colorectal cancer, but, again, early detection and monitoring are vital in increasing survival rates.
Exact Sciences conducted one of the most extensive studies in colorectal cancer screening ever (called the DeeP-C trial), analyzing data collected from about 10,000 patients, aged 50 to 84, across 90 clinical sites. Hitting all of its endpoints, preliminary top-line data showed Cologuard demonstrated 92 percent sensitivity for the detection of colorectal cancer and 42 percent sensitivity for the detection of pre-cancerous polyps. Overall, the test achieved a specificity of 87 percent for the trial.
In June, Exact Sciences submitted its application for Cologuard to the FDA, seeking approval of a commercial launch of the test.
Exosome Sciences, a subsidiary of Aethlon Medical, is developing tools to detect and quantify the presence of exosomes, cell-derived vesicles found in all biologic fluids. Once a dormant asset of Aethlon, the company has aggressively launched Exosome Sciences, appointing two of the most well-known names in the industry to the team. Dr. Cicek Gercel-Taylor was hired as clinical research director and Dr. Douglas Taylor as chief scientific officer. Exosome Sciences is in the process of building out its lab facilities located in Monmouth Junction, New Jersey, an area better known as Einstein Alley.
Previously believed to be simply cellular debris, exosomes are now known to provide critical information to researchers in identifying and monitoring a broad array of diseases. New technologies have provided scientists with a solution to the problem of separating exosomes from their environment, unlocking the valuable information.
The company’s lead product, the Enzyme Linked Lectin Specific Assay, or ELLSA, has been validated to identify the presence of exosomes underlying the human immunodeficiency virus (HIV), tuberculosis (TB), and various forms of cancer, including ovarian, melanoma, breast, lymphoma, and colorectal. The company is advancing its ELLSA platform to diagnose these and other diseases. It can also be used as a tool that monitors disease progression/regression in response to therapy as a means to improve patient management and outcomes. In the oncology field, Exosome Science products will also be positioned to serve as companion diagnostics that determine when to initiate Aethlon’s Hemopurifier therapy or provide real-time monitoring of tumor responses to Hemopurifier therapy. The Hemopurifier is the first medical device from Aethlons ADAPT product pipeline to treat infectious disease and cancer.
Watch Aethlon Medical’s CEO, Jim Joyce, discuss the Hemopurifier, a blood filtration device that is the company’s lead product.
In any of these technologies, the diagnostic process is quite complex but the sample collection process is extremely patient-friendly and simple. Another great benefit of utilizing such easily obtainable specimens is the fact that sensitivity generally increases with sample volume. Aethlons Exosome Sciences may have an upper hand in some respects to its larger peers because of horizontal and vertical expansion possibilities (i.e., different sample sources and broader range of indications initially) and its connection with the Hemopurifier, although the offset is the company’s stage of development. The main takeaway here is the large growth potential of each company. As less invasive diagnostic tools continue to be developed, they should play a key role in creating better health conditions and controlling expenses in a great array of disease conditions and therapies.
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