For nearly 50 million Americans, Medicare approval is crucial for determining what medical procedures one can undergo. Transgenomic (OTC: TBIO) stated today that after quite a bit of legal wrangling and waiting, it had finally received Medicare’s endorsement for its Clopidogrel Genetic Absorption Activation Panel.
This simple saliva test is used to identify patients who cannot completely absorb or activate clopidogrel due to reduced function of CYP2C19 or ABCB1. C-GAAP analyzes markers in both genes to identify patients who are at a genetically-increased risk of major adverse cardiovascular events due to diminished effectiveness of clopidogrel.
Clopidogrel is the most widely prescribed antiplatelet drug in the United States. It is used to reduce the risk of heart attacks, strokes, and even death in millions. However, the drug’s effectiveness is limited to people who can adequately absorb the drug through their intestines and then activate the drug by enzymes produced in the liver.
Beyond this, those unable to properly absorb clopidogrel due to a genetic predisposition display a 50% increase in major adverse cardiovascular events. It is for this reason that the FDA forced makers of clopidogrel drugs to include a black box warning beginning in 2009. Additionally, this understanding prompted both the American College of Cardiology and the American Heart Association to push for genetic testing prior to the prescribing of clopidogrel.
“Confirmation of Medicare coverage is a major commercial milestone for Transgenomic and an important step toward widespread use of C-GAAP,” said Craig Tuttle, Chief Executive Officer of Transgenomic. “Medicare is the largest U.S. payor and currently covers approximately 75% of the patients for whom the C-GAAP test would be ordered. Acceptance by Medicare removes a significant barrier for physicians and allows for a more rapid adoption of this important genetic test. There are approximately 6 million new patients that are prescribed clopidogrel each year.”
Trading of Transgenomic began today at $0.83 and remained fairly steady until the announcement was made midday. On the heels of this massive announcement by National Government Services, the designated Medicare fiscal intermediary in Connecticut, trading volume immediately ramped up and Transgenomic flirted with breaking the $1 barrier for the first time in months.
Ultimately, Transgenomic closed the day at $0.98, up a touch more than 18% on a trading volume of 398,363 shares.
Everybody wants to go to heaven, but nobody wants to die. For many on Medicare, however, the costs associated with genetic testing were daunting and the tests subsequently ignored. For now, Transgenomic sits in the driver’s seat as its test is 100% proprietary.
As people’s lifespans increase year in and year out, more and more people will be prescribed clopidogrel and will look to increase their confidence in their treatment plans with Transgenomic’s testing. If this does indeed pan out, look at Transgenomic as a sound investment in the health of others.
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