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- GenTel BioSciences, Inc.,
a developer of protein chip technologies, has received a $1.2 million Phase II SBIR grant from the National Institutes of Health to develop a test that promises less painful diagnosis of respiratory allergies.
An estimated 50 million Americans suffer from mild to chronic seasonal allergies, and current diagnostic tests are uncomfortable, especially for children and senior citizens. GenTel's protein chips use a multiplex assay, a new type of test, to rapidly test a patient's blood for reactivity to many potential allergens at once. Using only a few drops of blood, most clinical or research settings would be able to use the allergy test kit in the research, rapid diagnosis, and subsequent treatment of respiratory allergies.
Perhaps more importantly, the test would replace existing time-consuming and painful diagnostic methods such as puncture tests, the most common technique for allergy diagnosis in the United States, and venous blood draws. These methods don't necessarily prevent children and seniors from seeking treatment, but they are uncomfortable and can impact the quality of care provided, according to Alex Vodenlich, CEO of GenTel.
To perform a puncture test, a physician introduces extracts containing suspected allergens underneath a patient's skin in multiple punctures. "They take five, 10, 20 of them, either on your arm or on your back," Vodenlich explained. "Then what you have to do is wait a few days to see how your body reacts to that allergen, and then usually there is redness and swelling or some kind of visual manifestation.
"That's nice, but it's really leaves the physician at a point where they have to interpret what that means. It's not very quantitative; it's very subjectively looked at in terms of how allergic you are to something. Some of them are obvious, and others are not."
Venous blood draws call for patients to provide sizeable amounts of blood and have a slow turnaround time for results, so a small prick of the finger involved in the new test is preferred over both existing methods.
Vodenlich said the company's biochips provide a more qualitative and quantitative way to measure how allergic patients are to certain allergens, which would be a leap forward in allergy diagnosis. GenTel has the allergens printed on a chip and then a few drops of blood are applied to the chip. If a patient has antibodies against those allergens, that can be detected on the chip.
Vodenlich said the grant would enable the development of a chip to detect 22 different respiratory allergens that people might inhale. The long-range potential is to go beyond 22, to somewhere between 40 and 100, but the exact number would involve more research.
The company also is developing biochips that could be used to test patient samples for the presence of and levels of various blood clotting factors and cancer markers. "We have a research project for prostate cancer, but we're also looking for other types of cancers," Vodenlich said.
While the chips have yet to be commercialized, the company already has technology platform products on the market, which it has sold to the likes of Pierce Biotechnology
and Glaxo Smith Kline
. They take the platform and develop their own research product tests for various applications.
GenTel expects to announce a partnership with another large life science company sometime in June.
The next stage for the chip platform is to develop tests, and the first test the company will be launching is the blood-clotting test, followed by a cancer chip. The allergy chip is a longer-term project because once it is developed, it then has to migrate onto an instrument platform. GenTel is collaborating on this project with Decision Biomarkers of Boston, Mass.
A key collaborator on the allergy project is Dr. Robert K. Bush, a professor of medicine at University of Wisconsin-Madison School of Medicine and Public Health. "What our company is all about right now is developing biochip tests that are going to be used in research," Vodenlich said. "The nice thing about the allergy chip is that it will first be used in research and validated by allergists like Robert Bush at the university and others that are part of this project.
"Once there is enough validation data, then it comes to the point where we determine how to make this into a diagnostic, and that's something that we would most likely partner with a diagnostic company to do."Taken for granted
The SBIR program is a competitive federal grant program that supports research by small companies. In 2005, GenTel successfully completed a Phase I SBIR that demonstrated the feasibility of the allergy chip concept.
GenTel now has been awarded six SBIR awards from the federal government, totaling over $2 million in the last three years. GenTel's Phase II application was boosted by a $50,000 Phase II matching grant from the Wisconsin Department of Commerce.
The company now employs 13 people but expects two or three more hires by year's end, and should be at about 20 employees by the end of 2007. It expects to report well over $1 million in product and service revenue this year, and it expects to break even or be slightly profitably by the end of 2007.