With the NY district court ruling in ACLU et.al. v USPTO/MYGN it appears clear that the bar for gene patents is super high and most will likely not reach it. Does this mean the end of gene patents or even just the BRCA1/2 patents?
No, but it is the beginning of slipshod sequencing and a whole host of labs testing for BRCA1/2 sequences. It is also the making of a SCOTUS case.
But here's why I think Myriad STILL is the gold standard.
A. They have the experience doing this testing
B. They have the infrastructure to handle national samples
C. They have the ability to analyze rare variants best. Why? They have the samples.....
That being said, could Quest or LabCorp begin BRCA testing? Yes and they would do a hell of a job.
One thing is for certain, Myriad will have a hard time justifying that 3120 USD price tag.
If you have MYGN maybe a short is in store?
The Sherpa Says: Myriad is how a genetics lab should be run, except for the outrageous price.
Monday, March 29, 2010
End of Gene Patents?
Posted by Steve Murphy MD at 4:44 PM 1 comments
Labels: aclu, BRCA1, BRCA2, gene patents, holy shit, mygn, myriad genetics
Wednesday, March 24, 2010
PGx in DTCG? Doesn't stand up to Useful testing.
HT Don Rule today as well as the ENTIRE Pharmacogenomics Advisory Group that I am a proud member of.
Posted by Steve Murphy MD at 4:38 AM 1 comments
Labels: 23andme, clopidogrel, cpmc, navigenics, PGx, plavix, tpmg
Tuesday, March 23, 2010
Why did P&G invest in Navigenics?
I kept beating myself up, trying to figure out why the largest food/products company in the world put money in Navigenics. Was it for nutrigenomics? Was it for the captive audience to market products to?
Posted by Steve Murphy MD at 12:36 PM 1 comments
Thursday, March 18, 2010
A moment of Clarity. Some DTCG is not bad.
Posted by Steve Murphy MD at 5:52 AM 5 comments
Labels: DTCG, Genomic Medicine, The Gene Sherpa, The personalized medicine group of CT
Wednesday, March 17, 2010
How can MDVIP use Navigenics Test for Medicine?
I have been harping on this say what you mean. Say what you do. Theme lately.
Posted by Steve Murphy MD at 5:54 AM 4 comments
SNPs for breast cancer risk? It Depends.
I hold in my hot little hands a copy of the NEJM, March 18th edition. In it there is an article which isn't even released yet.
Tuesday, March 16, 2010
The Argument Against DTC Genomics Marketing and such
Keith Grimaldi and Daniel MacArthur and Andrew Yates and I have a little bit of confusion. I think we are arguing over 2 different points.
I think many people have misunderstood our messages. So to be simple.
A. Keep the Medical, Well, Medical.
1. Medical Genetic tests that are to be used clinically should have clinical input
2. Medical Genetic tests should be regulated according to the laws of each state/country
3. DTC Genomic tests come in several flavors. The DTCG Medical tests should be Medical.
I have been championing this one for a LONG time. The arguments for this are pretty clear
1. Without clinical input, selling medical tests without an understanding of their use on a FIRST HAND basis is a bad business plan. Also, the risks of a non physician over marketing these tests as to be used for too many things or used before the science pans out could harm the consumer. Think OvaSure......
How? Via false advice and guidance, delivered not by a physician, but by a website.
Who takes accountability and liability for this? The answer no one. Thus, the chain of trust is broken and the patient is left no recourse.
Posted by Steve Murphy MD at 5:16 AM 9 comments
Labels: 23andme, andrew yates, daniel macarthur, keith grimaldi
Sunday, March 14, 2010
BRCA testing by 23andME is the same as Myriad Genetics.
February 2009 23andMe entered into clinical medical testing of DNA variants which are the exact same variants Myriad Genetics tests for. There is only ONE use for this test. That is a clinical use. When these results are obtained clinical counseling is the standard of care for delivery of these results. Not a flashy webportal......
Minimizing the seriousness of a medical test looked just as awkward by us in the first video as it should be by showing it on a blimp or at a cocktail party or highway billboard sign.....All things that Linda Avey and Anne Woj decided to have their company do....
The Sherpa Says: Misha is correct, Medical Geneticists painted themselves into a corner by harboring in the rare disease port. This allowed people who have no G-dDamn business in medicine, to play doctor at parties and on the internet!
Posted by Steve Murphy MD at 4:03 PM 0 comments
Friday, March 12, 2010
The FDA, 2c19 and the ACC
Did anyone see the FDA issuance of the better warning that as many as 14% of patients will not benefit from Plavix/Clopidogrel?
Posted by Steve Murphy MD at 4:36 PM 2 comments
........DTC Genomic Medicine?
Back in February of 2009 23andMe/Serge decided to do testing for genetic founder mutations.........
Yet they claimed it wasn't medicine and should not be used for medicine.
BRCA Ashkenazi Jewish founder mutations offer information that can confer an elevated risk of Breast, Ovarian, possibly melanoma, Pancreatic and maybe blood cancer.
There really isn't any other thing that these tests can be used for other than medical decision making and diagnosis. The diagnosis would be Genetic Risk for Cancer. There is a medical code for it in the International Classification of Diseases 9th Edition. In fact there are multiple codes. The v84.0 super family of codes.
Granted this presentation was a bit manic and the iPhone volume control was horrible (turn down your speaker volume). But the point is clear. Either founder mutation testing is a medicine or it is not.
You cannot have it both ways. Say what it means. If that means your state requires physician consultation or ordering, do it.
If it doesn't, well, I strongly recommend you receive that healthcare provider service.
Posted by Steve Murphy MD at 7:23 AM 6 comments
Thursday, March 11, 2010
The problem with Comparative Whole Genomics......
I have been having this debate with a good friend and mentor.
Posted by Steve Murphy MD at 7:11 AM 2 comments
Labels: BGI, comparative genomics, knome, Wellcome Trust
Tuesday, March 9, 2010
What a difference a year makes
Posted by Steve Murphy MD at 4:58 AM 10 comments
Labels: 23andme, aclu, genomics law report, Google's master plan, law, myriad genetics, navigenics
Thursday, March 4, 2010
Just 4 million? What 23andMe is worth.
So by now I am certain everyone in the DTC genomics world has seen this BNET story
The industry is morphing here. They see that the only sustainable solution is partnered with health care practitioners is a smart way which benefits all, but most importantly, the patient....
Posted by Steve Murphy MD at 8:19 AM 1 comments