Friday, August 17, 2012

Only 'Law of Nature' Exemption Allowed - US Circuit Court

The issue in the  Myriad Genetics and Prometheus Labs cases could be expressed this way: work of man or work of nature? A gene exists as a part -a very tiny part of a human being - but it would never be able to be known or isolated without a technology that a private company invents and markets. 
A 2-1 panel of the U.S. Federal Circuit Court of Appeals in Washington, D.C., on Thursday upheld the biotechnology company's right to patent "isolated" genes known as BRCA1 and BRCA2, which account for most inherited forms of breast and ovarian cancers.  The American Civil Liberties Union, which brought the case, argued that patents on human genes violated the First Amendment and patent law because genes are “products of nature.”  
This decision comes off remand, five months after the Supreme Court, in a case involving a blood test developed by Prometheus Laboratories, unanimously ruled that companies were not permitted to patent observations about natural phenomena.  
The Court said: “Everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.”
But based on the Supreme Court remand, the court denied the company's effort to patent methods of "comparing" or "analyzing" DNA sequences.  Women who test positive using Myriad's gene test, called BRACAnalysis, have an 82 percent higher risk of breast cancer and a 44 percent higher risk of ovarian cancer in their lifetimes.

Wednesday, August 15, 2012

Epigenetics: New Kid on the Block in Cancer Therapeutics

Monoclonal antibodies, the shining star in the anti-cancer therapeutics firmament, are faced with some new competition. While epigenetic therapeutics have been around for a while, a raft of new clinical trials are in progress, and with any luck the next few years will see a number of FDA approvals for these agents. 

As was pointed out at recent symposium (Third World Epigenetics Summit, Boston, July 24-26), epigenetic drugs offer a number of important advantages over other forms of cancer treatment. First of all, their mechanism of action is well understood, as they target a specific enzyme in the oncogenic process. Secondly, they are small molecules, which means they can be taken orally, saving the patient discomfort, cost and inconvenience. 

Thirdly, there are already FDA-approved epigenetic anti-cancer drugs available, such as azacytidine, and trials can combine an approved drug with one of the compounds under evaluation. And finally, epigenetic drugs, unlike traditional antimitotic agents, are specific in their targeting. Rather than blasting away, machine gun style, at the objective, they aim at a very specific reaction site within the cell. So far their side effects have proven to be relatively minor.

The last century of the war on cancer certainly serves as a powerful admonition against irrational exuberance, but at this stage there is certainly reason for positive beliefs, and the coming trials will be closely followed.

Our report on Epigenetics is available from Kalorama Information at our website.                              

Tuesday, August 14, 2012

BD Max MRSA Earns Moderately Complex Rating

This Genome Web article highlights yet another entry into the MRSA testing world - BD's assay has just received moderate CLIA.   Already with FDA approval, this additional rating allows the test to be performed by a qualified laboratory technician, which means that hospitals can perform the test and do not need to send it to a central lab for processing.  

This is critical for what has become the most successful of the molecular tests, those that can test for an infection to determine if a patient needs isolation or special drugs.   This information is needed fast, so slower testing methods, even if cheaper, are not as useful as molecular solutions.   Once, bold predictions were made about molecular testing markets (yes, even in some cases by Kalorama's reports earlier in the last decade) but for the most part we and other market watchers have observed over the years how it has been hospital infection testing that has met the growth expectations while cheaper methods are stubborn in other areas of medicine.  

Kalorama's Report, 'Hospital Infection Markets,' details the developments in this market and forecasts revenues for the next five years.