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Biosearch customers hail from a multitude of disciplines all unified in their search for understanding the processes that govern living systems. They work in government, academic, biotech and pharmaceutical research labs. Their research interests range from detecting single-celled organisms in the environment to analyzing complex signaling pathways that influence human health, and they can be found conducting their research throughout many different countries. Over the next months, this column will introduce you to a number of our customers and the interesting and important work they are doing with Biosearch products.
Tom Briggs, Project Manager of Diagnostic Product Development for Gentris. |
Gentris Corp., Diagnostic Division
We had a chance to exchange thoughts with Tom Briggs, Project Manager of Diagnostic Product Development and learn more about this test and the future of personalized medicine.
The test that we have developed can detect mutations in the CYP2C9 & VKORC1 genes which
are instrumental in warfarin (Coumadin®) metabolism and blood clotting. It boasts a turnaround
time of about 30 minutes, an important consideration when quick decision-making
about therapy options and dosages is required. The test is compatible with blood, saliva and
buccal specimens.
We envision that this test will be performed in major medical centers and CLIA registered
reference laboratories. Since our assay is very easy to perform, it may also be applicable
for smaller physician groups that specialize in cardiology treatment. This test is important
because CYP2C9 and VKORC1 are two genes known to be instrumental in making warfarin
treatment decisions. Warfarin has a very narrow therapeutic range – too little and there is risk
of blood clots; too much and patients can bleed to death. In fact, the FDA has indicated that
they intend to re-label warfarin recommending that these tests be performed prior to making
dosage decisions.
Physicians commonly prescribe warfarin for patients with a history of atrial fibrillation, deep
vein thrombosis, pulmonary embolism, or recurrent stroke, as well as for patients who have
had heart valve replacements. Every year there are 3 million new warfarin patients in the
United States and roughly 10% will have an adverse reaction to the drug. A pharmacogenomic
test for warfarin would help decrease the number of adverse events and increase the quality
of life for patients taking the drug.
Personalized medicine is in its infancy stage compared to other diagnostic methods, but with
the recent completion of the Human Genome Project we are uncovering the function of a variety
of genes. This knowledge will be applied to pharmaceuticals and we will begin to slowly
unravel why certain drugs work for certain people. The future for personalized medicine looks
very bright. There is a push to require that every new drug have a corresponding genetic test
that will tell the patient and physician if this drug will be effective and safe in treating the patient.
Personalized medicine will help take the guesswork out of prescriptions and decrease
overall health care costs.
qPCR has become the gold standard for a majority of laboratory procedures and multiple
instruments have or will be cleared soon for In-vitro diagnostic applications. Clinical laboratories
will move from traditional qualitative methods of diagnosis to the more quantitative method of qPCR.
The biggest hurdles in the acceptance of qPCR as a diagnostic tool are educating physicians
about when to order the diagnostic test and getting insurers to reimburse for the cost. Most
of the qPCR based tests we are talking about are less than 5 years old and most physicians did
not learn about these methods of diagnosis in medical school. Speaking with the physicians
and proving the validity of the test will be a point of emphasis for all qPCR diagnostic testing
companies.
For more information on the Gentris Corporation please visit their website at: www.gentris.com.
To view a Gentris PowerPoint® presentation on Pharmacogenomics click here. |
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