Iris BioTechnologies (IRSB), Genomic Health (GHDX) and Affymetrix (AFFX) are three of the major players in one of the hottest fields in biotechnology today – personalized and targeted medicine. While Affymetrix, the industry leader in microarray technology, has dominated the research arena, Genomic Health has helped bring molecular diagnostics technology to the clinician paving the way for an early adoption of Iris’s more advanced technologies, products, and services.
Using its proprietary Nano-biochips(TM) and BioWindows(TM) medical informatics system, the company is on the cutting edge of being able to determine the most desirable medical solution for individual patients based on their molecular signatures and personal profiles.
Reason #1: An Emerging New Technology
Iris’s medical informatics system, BioWindows(TM), utilizes a powerful database of molecular signatures, in-depth patient demographics, lifestyle information, family medical histories, and treatment response profiles to uncover optimal solutions for many diseases. While Iris’s present focus is breast cancer, other cancers, heart disease, diabetes and neurological disorders are in its pipeline of future products.
In cancer applications alone, this technology will vastly improve the quality of treatment. The company’s clinically accurate tools are designed to help medical professionals measure hundreds of relevant genetic/genomic malfunctions seen in cancer patients and devise the specific therapeutic regimen that can save and optimize the patient’s quality of life.
Meanwhile, the company’s Health Passport solution enables this life-saving information to be stored and shared on the web in a HIPAA-compliant setting. This allows families to build multi-generational medical family trees, which help assure that they receive more personalized care now and in the future – the right treatment for the right patient at the right time.
Reason #2: Growing Demand in End-Markets
The new U.S. healthcare bill, which became law on March 23, 2010, includes a section on creating an independent Patient-Centered Outcomes Research Institute. The institute’s research will focus on areas that are well aligned with Iris’s BioWindows medical informatics system, which demonstrates the technology’s growing importance in the medical community.
Meanwhile, the company’s initial oncology end market continues to see a rise in cases worldwide. There are more than 2 million breast cancer patients in the U.S. alone, with approximately 180,000 newly diagnosed patients in 2009, and the same number expected in 2010. The testing market for this disease alone could exceed a million tests per year, according to some sources.
Reason #3: A Clear Path Towards Commercialization
One of the greatest problems with medical innovations is customer adoption of their new technologies. Even if they show safety and efficacy, new medical tools often face lengthy government approval processes and an end market that is extremely slow to respond. This challenge is less of an issue for Iris since the company’s main competitor, Genomic Health, has already done much of the legwork in educating the market about personalized healthcare solutions enabling Iris to rapidly grow its business. Genomic Health currently performs about 40,000 Oncotype Dx breast cancer recurrence prediction tests annually, with annual revenues of approximately $150 million. Without FDA approval, Genomic Health is restricted to offer their test only in their California CLIA laboratory.
Meanwhile Iris BioTechnologies has strategically positioned itself to be successful regardless of when and how the FDA decides to regulate complex molecular diagnostic and prognostic products. Though the Nano-Biochips are designed to be FDA-approved kits the company presently has the capability to launch the clinical BreastCancerChip™ as a CLIA laboratory test, similar to Oncotype Dx. Upon FDA approval, all the Iris tests can be performed in any certified laboratory in the country.
All in all, Iris BioTechnologies (IRSB) represents an opportunity for investors to get involved on the ground floor of the upcoming revolution in personalized medicine!
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