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      Headlines - April 10, 2006
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R. Lewis Dark: Labs Poised to Add Value to Docs and Patients

CAREFULLY READ OUR COVERAGE AND ANALYSIS about cytochrome P450 (CYP450) testing on pages 2-9. CYP450 testing is likely to be one of the most important developments in laboratory medicine in the past two decades.

I say that for two reasons. First, test panels designed to detect multiple polymorphisms in cytochrome P450 will allow physicians to determine, in advance and with increasing accuracy, how a specific patient will respond to a specific drug. Second, CYP450 testing will be appropriate prior to issuing prescriptions that cover 25% or more of the existing formulary.

CYP450 testing promises two positive outcomes for the healthcare system."Trial and error" prescribing will be greatly reduced, since physicians will know ahead of time whether the patient will get therapeutic benefit from a specific drug. The number of adverse drug reactions (ADRs) will decline, since the physician was able to determine, in advance, that the patient was a no-metabolizer, slow-metabolizer, or ultra-fast-metabolizer.

With 2.8 billion prescriptions filled each year in the United States, this positions CYP450 testing to become a high-volume test for any laboratory with a certain size and scale. Because CYP450 testing yields high clinical value, experts believe it will be appropriately reimbursed. These two reasons, taken together, are stirring excitement among certain vendors and the nation's largest laboratory companies.

I'd like to add one point to our coverage about CYP450 testing. I believe that consumers will be quick to push rapid adoption of this test by individual physicians. As the word gets out about how this test can help avoid serious, even fatal, adverse drug events, consumers will do their homework. Educated and armed with facts printed from the Internet, they will challenge their doctors and insist that these tests be ordered for themselves and their family members. This is a major development and you are among the first to understand how and why CYP450 testing has the potential to be transformational across our healthcare system.

Furthermore, this is another example of how THE DARK REPORT gives you actionable business intelligence, along with the time and knowledge needed to position your laboratory or pathology group ahead of events. Once more, THE DARK REPORT has provided you with a priceless competitive advantage over your laboratory competitors!



CYP450 Testing To Have Major Clinical Impact

Analysts predict that wider clinical adoption of CYP450 testing will benefit lab industry

CEO SUMMARY: Pharmacogenomics, companion diagnostics,"personalized prescription drug therapy"—by any name, use of molecular diagnostics to guide clinicians in the prescribing and dosing of drugs is about to expand exponentially. Some experts predict that CYP450 testing alone will be a $1 billion business for labs in just a few years. Here's a look at the forces driving this new opportunity.



CYP450 Plays Major Role In Drug Metabolization

Potential for CYP450 testing to be done in support of tens of millions of prescriptions

CEO SUMMARY: Each year, over 100 million new prescriptions are written for two classes of drugs with metabolic pathways affected by genetic variations in cytochrome P450. There are strong clinical arguments in favor of testing individuals for these genetic mutations to determine whether they are no, slow, or ultra-fast metabolizers of these drugs, before writing the prescription.



Outcomes Update: Payers Want Patients to Shop Prices at Doctors' Offices

Health insurers plan to use cell phone feeds to provide prescription drug prices to patients



Placenta Registry Stirs Unwarranted Controversy

Ob-gyns and pathologists nationally are working together to more effectively examine placentas

CEO SUMMARY: On the surface, the"exposé" published by The Oregonian newspaper on February 12 seemed designed to sensationalize an effort by local obstetricians, hospitals, and pathologists to do a better job of evaluating placentas taken from patients who had experienced a difficult birth as an arrangement intended to provide a defense in malpractice cases. But deeper investigation uncovers a more benign story.



Patient Safety Trends: New Guidelines to Require Single-Patient Hospital Rooms

Goal is to reduce nosocomial infections, cut downmedication and other errors, increase privacy



Lab Industry Briefs:

ASCP ACQUIRES MIME'S CYTOLOGY TRAINING AND PROFICIENCY TESTING

HOSPITAL LAB LOSES MEDICARE LICENSE IN VICTORVILLE, CALIF.


INTELLIGENCE:

INTEL PREPARES SPECIAL PRODUCTS FOR HEALTHCARE

MORE ON: Redwood Tox

 

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