In view of the article by Dr. King in the current issue of JAMA advocating universal gene testing for women, I predict that the outcome will make the bounce due to the Angelina Jolie publicity bounce look like a mole hill compared to the huge mountain of revenue that can result from Dr. King's advocacy.
The Angela Jolie publicity led to a relatively small population of women who empowered themselves to seek testing. The JAMA article will encourage doctors with integrity to seek testing for the ultimate best interests of their patients. Further, this call for universal testing may lead to the AMA to reverse their sexist attitude to oppose allowing women to be informed of the condition of their own bodies so that they may decide what is best, in consultation with their doctors. Knowledge is power: knowledge of their status will allow the vast majority of women, as Dr. King argues, to go about their lives with knowledge of their negative status, while giving those testing positive time to consider various treatment alternatives.
There are over 50M women in the U.S. between the ages of 30 and 55, with only about 1M having been tested to date. If only 75% are ultimately tested, and Myriad can ramp up capacity, the potential testing of 37.5M, at 500K/mo. revenue ramps up to about $1B/mo. in the Women's Health division alone, compared to less than $1B/yr. for the entire company at the present time. Given that there is no co-pay for the tests under Obamacare, there is no sane reason to oppose getting tested.
With this q. ending 9/30/14, there will be little or no effect until the Dec. q., which will be reported in Feb./15.
A sizable ramp up could force the analysts to wake up and smell the profits, as opposed to their current ignorant concern for the competition of the 7 patent pirates.
JMHO, of course. Be sure to do your own DD.
Sentiment: Strong Buy
the stock has been in a downtrend since april. one could argue it is a consolidation or base building period as well. the short position has been very safe, but complacement, preferring not to push the stock further down in trade. i find that odd and a bit concerning. they seem very confidant. management appears to have badly misread the timing of medicare reimbursement for prolaris. they also are not publicly building a case for the test, which is clearly a strategic decision to lay low waiting for a decision. i doubt the delay in announcing reimbursement is a positive. it is a big decision by medicare and it will cost billions and involve all sorts of competing companies. they may have to allow half a dozen tests, idk. the only way to set a standard as to what gets covered as effective and what does not may take years of study and consideration. hence my concern over myriad's silence and obfuscation of the data. at this point i would think, that reimbursement is going to be denied pending further study and the setting of better comparative standards. this is based on no particular insight, just surface observation and a lack of excitement apparent from mygn themselves, the NYT review of the field, the mygn website. etc.
This was reported in the Science section (p. D3) of yesterday's NY Times. The researcher, Mary-Claire King, came up with the connection between mutant BRCA1 and cancer: she discovered the gene, not the test for it. She proposed that screening should include "all women 30- or older for cancer-causing genetic mutations" with no exceptions such as for family history. She also said "you only needed to be tested once, and the vast majority of women will not have a mutation and can go about their life." and "women who do learn they have a mutation that's comparable to Angelina Jolie's and confers very high risk can begin to think about what that means". She also argued: "Why should women be protected from information that will empower them and allow them to control their lives? We don't need that kind of protection".
A common recommendation is to have the ovaries removed by age 40 because ovarian cancer is difficult to diagnose early and, also, removing the ovaries may reduce the risk of breast cancer.
Universal testing of women is coming, IMHO. That's over 1M women in the U.S. alone turning 30 each and every year.
The article also describes how she came up with her discovery.
Sentiment: Strong Buy
for women over 30 with family history of breast cancer..made by the researcher who came up with the BRCA test..Myriad makes the test for BRCA 1 and 2..do the math..they also have promising melanoma work from what I've heard..I'm in at $36 and change..I think this is a winner...I'm obviously biased..very high short activity as well...could get squeeze.
Gene Patents, Knocks US High
By Ryan Davis
Law360, New York (September 08, 2014, 7:09 PM ET) -- An Australian appeals court ruled Friday that Myriad Genetics Inc.'s patents on isolated genes associated with a risk of breast cancer are patent-eligible, and criticized the U.S. Supreme Court, which it said "wrongly" invalidated Myriad's similar U.S. patents last year for claiming natural material.
The Full Federal Court of Australia affirmed a lower court's decision from last year that two genes, known as BRCA1 and BRCA2, that were isolated by Myriad are "an artificially created state of affairs" that are eligible for a patent.
The take-home is that the benefit of whole-population screening is predicted to be indistinguishable from zero (agreeing with experience), while the cost in both money and morbidity is considerable. The test is useful in the right situations, but not for screening where there is no reason for initial suspicion of prostate cancer.
to use Prolaris, you have to find a cancer of the prostate. to use PSA, you just have to find a prostate!!! LOL
AJ would not be a good spokesperson for this test....no prostate.....
In fact, one of the big uses of Prolaris may be to mitigate [somewhat] the harm done by excessive PSA testing.
But the point is that we should be interested and encouraged by positive findings on the benefits of a Myriad test, but keep in mind the good reasons why medical practice is slow in expanding test use.
Let's say that there is a test that could be run on biopsy specimens that would define a tumors aggressiveness...... direct care and save $$$....oh!! Prolaris!
Be very careful before saying that a test can do no harm. Everyone's pet bad example is PSA testing of healthy men. Costs a lot of money total, which is a harm right there (and PSA costs less than MyRisk). Leads to an enormous amount of unwarranted anxiety and many unnecessary surgical procedures. No demonstrable public health benefit (raw prostate cancer death rate is the same in comparable countries where the test is and is not common). But a physician who doesn't do PSA screening risks being sued, so in the US it's hard to stop doing the test routinely.
So anyway, this one study concluded that screening without prior suspicion is justified in a particular population. It's interesting, and even hints that more testing should be done in general, but let's not rush beyond what that American Cancer Society guy said.
Remember Gene By Gene was given worldwide rights outside of North American. unsure if there is a licensing fee paid to Myriad. the details were never disclosed.....
Feb 7, 2014 BRCA Patent Owners and Gene by Gene, Ltd. Resolve Patent Suit
HOUSTON and SALT LAKE CITY, Feb. 7, 2014 (GLOBE NEWSWIRE) -- Gene by Gene, Ltd. and Myriad Genetics, Inc., the University of Utah Research Foundation, HSC Research and Development Limited Partnership, Endorecherche, Inc., and the Trustees of the University of Pennsylvania (the "Patent Owners") have reached an agreement to settle the patent infringement lawsuit between them regarding BRCA testing.
Under the agreement and effective immediately, Gene by Gene will cease selling or marketing clinical diagnostic tests within North America that include analysis of the BRCA1 and/or BRCA2 genes as a standalone test or in conjunction with gene panels, but Gene by Gene will continue to offer such tests outside of North America. The Parties have also agreed that Gene by Gene may continue to offer its whole genome and exome products and services, which include the BRCA genes, as well as Gene by Gene's custom array products that test variants for inherited Mendelian disorders, including variants for BRCA1 and BRCA2, worldwide.
Each country has its own patent law. This could be a precursor for similar rulings in Canada and Europe, which are key countries because they have single payer health insurance systems, which similar to Medicare, except that the whole population qualifies.
Sentiment: Strong Buy