Thursday, January 31, 2013

New Report Shows Rising IVD Procedures

Testing is on an upward trend, according to Kalorama Information's IVD Procedure Volume and Pricing Analysis   Clinical laboratory medicine plays an integral role in healthcare and disease management, as it estimated that approximately 80% of physician’s diagnoses are a result of laboratory tests.

Lab procedures will go from 19 billion in 2012 to 23.5 billion in 2017, according to our procedure volume analysis, as testing proves its importance in diagnostics and treatment regimen decisions to providers, payors and patients.

 In addition to disease diagnosis, clinical lab testing is also performed to evaluate disease progression, monitor drug treatment and conditions, determine individual therapy, and several other reasons.

Diagnostic laboratory technology has changed dramatically in the past few years, due to the publication of the human genome project and advances in functional genomics, bioinformatics, automation, miniaturization and microelectronics as well as rapid development and proliferation of novel telecommunications technologies.  Molecular assays are among the fastest growing procedures, according to the report.  

Monday, January 28, 2013

Surprise Over Oxytrol Approval

In a press release last week, Kalorama Information said that there would be more Rx to OTC switches, and to count on it.... but we had no idea how quickly that would happen.  Last Friday, the FDA announced that Oxytrol was approved by the FDA for OTC status this year.   Merck's OXYTROL is a prescription medication that has been proven to treat the symptoms of overactive bladder.   The product is expected to be released end of year.  

The FDA advisory panel in November recommended not allowing the drug to switch yet, so Kalorama did not include the product in it's Rx to OTC Switches report.  

"Everyone is a bit surprised," analyst Melissa Elder tells the Kalorama Editors. "especially in light of no restrictions mentioned--such as pharmacist-dispensing option--and the concern over men gaining access to the product without the monitoring of a pharmacist. "

According to Elder, it raises some concerns over the possibility of men not being evaluated for prostate problems--and as we all know many men will avoid a Dr. visit if at all possible. 

Kalorama had forecasted 2014 approval in its report so our forecast is not affected in any large scale by the faster than expected approval, especially as Merck should not see revenues until fall 2013.