Myriad ONLY tests validated and actionable genes.
MyRisk reimbursementreimbursement/coverage should improve across the board IMHO.
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Procuring Personalized Medicine Patents In US Vs. Europe
Protecting Investment in Personalized Medicine
It is old news that the U.S. Supreme Court’s patent-eligibility trilogy
(Prometheus, Myriad, and Alice) has significantly challenged the patenting and protection of diagnostic methods that are key to personalized medicine. These decisions and the subsequent decisions by the Federal Circuit applying Prometheus, Myriad and Alice, as well as the USPTO’s interpretation of the courts’ rulings have forced upon those interested in patenting these discoveries to reassess what can and should be patented. Purified or isolated naturally occurring products of nature (e.g. DNA, proteins, chemical compounds) and the correlation between a clinical marker, such as a genetic mutation or cell-surface marker, and clinical intervention or prognosis are no longer broadly patent-eligible.
A patent strategy that may still protect a companion diagnostic is a “test-and-treat” type claim that links the diagnostic test and the therapeutic intervention. However, such a claim requires two actors for infringement: the technician or laboratory performing the test, and the actor directing administration of the therapeutic. A method claim having steps divided between two actors has been challenging to enforce against two parties because of the Federal Circuit’s Muniacuction holding that direct infringement under 35 U.S.C. § 271(a) could only occur where all steps of the claimed method are performed or attributed to a single entity. However, the Federal Circuit’s expanded application of direct infringement here under Akamai Technologies, Inc. v. Limelight Networks, Inc., may provide a theory under which test-and-treat claims can be enforced to protect diagnostic innovation.
Wells Fargo upgrades, cites product strength
Aug. 25, 2015 10:27 AM • SA Editor Eric Jhonsa
"We believe MYGN's share in hereditary testing is stable, and positive developments in new markets could drive accelerating growth," arguesargues Wells Fargo, upgrading to Outperform following a talk with CFO Bryan Riggsbee and IR chief Scott Gleason. The firm's valuation range has been hiked to $36-$38 from $33-$34.
Wells believes Myriad's hereditary cancer testing share has stabilized around 90%, following losses seen in the wake of the Supreme Court's 2013 gene patent invalidations. "We believe MYGN's key advantage is the quality of its database, which we better appreciate following meetings with management."
The firm also expects $10M-$12M in revenue this year related to Myriad's Prolaris testing product, and notes VectraDA demdemandand improved in FQ4 (the June quarter) following "several quarters of stagnation." A new CEO/CFO are also seen as a positive, and Myriad's Sep. 14 analyst day a potential catalyst.
Myriad Genetics announces that the Medicare Administrative Contractor for Myriad, has issued a final local coverage determination for Myriad's Prolaris prognostic test for assessing the aggressiveness of prostate cancer
BRACAnalysis CDxTM testing at the time of cancer diagnosis is critical for determining germline BRCA status for all patients with ovarian cancer. A BRACAnalysis CDx result is key to determining targeted chemotherapeutic strategies, including the PARP inhibitor LYNPARZA....
Fewer than 27% of newly diagnosed patients with ovarian cancer know their BRCA1 and BRCA2 mutation status.
However, studies show that in unselected series of patients with ovarian cancer, roughly 13-14.1% carry germline BRCA1 or BRCA2 mutations
Despite advances in treatment for ovarian cancer, rates of cure for patients with advanced stage disease remain low. In 2015, approximately 14,000 women will die as a result of ovarian cancer, representing ~50% of gynecologic malignancy deaths. The majority of women diagnosed with ovarian cancer are identified at a FIGO Stage III (50%) or Stage IV (13%), with 5-year survival rates of 29-49% and 13%, respectively. Management of patients with advanced stage ovarian cancer usually involves primary cytoreductive surgery followed by first-line chemotherapy with a platinum/taxane regimen. Despite typically positive responses to treatment initially, relapse rate is high, and cure is unlikely.
Myriad 25-gene panel, myRisk Hereditary Cancer, doubles the detection of inherited cancer risks in breast cancer patients, compared with single-syndrome testing. A pan-cancer panel approach to hereditary cancer testing has the potential to identify actionable mutations that would be missed by a traditional approach to testing. This new and more comprehensive approach to hereditary cancer testing, made possible by Next Generation Sequencing, can prevent a missed diagnosis and a missed opportunity for meaningful medical intervention.
Recent NCCN guidelines include surveillance and prevention options for CDH1. Preventive gastrectomy and/or upper endoscopy are recommended for risk of gastric cancer. Breast cancer risks from germline CDH1 mutations exceed the 20% lifetime threshold set for screening breast MRI adjuvant to mammography, and recent NCCN guidelines make this explicit for CDH1.
clear out the short position....
Johnathan Lancaster, M.D., Ph.D.
Vice President, Medical Affairs, Myriad Genetic Laboratories
“We are able to target cancer by matching a patient to a specific therapy based on the biology of his or her own tumor.”
What is the most important thing patients and physicians need to know about Personalized Medicine?
Personalized medicine provides the right patient with the right drug, with the right dose at the right time. The enablers of personalized medicine are companion diagnostics—tests that help doctors better predict which treatments will be most effective for individual patients. In cancer, advances in genetics research allow us to look inside a cancer cell to understand what makes it behave the way it does. We are able to target cancer by matching a patient to a specific therapy based on the biology of his or her own tumor.
How will personalized medicine change health care in the next 10 years?
Patients are filled with hope when they hear that their doctors are going to select therapies tailored to their individual disease and their individual biology. In the next 10 years we can expect many more companion diagnostics are on the way, as a result of close collaborations between companies like Myriad and biopharmaceutical companies that develop targeted therapies. And that’s incredibly exciting for the future of health care.
Five new studies on hereditary cancer testing were recently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. The studies demonstrate the increased sensitivity of the Myriad myRisk™ Hereditary Cancer compared to syndrome-specific testing in multiple disease areas:
1. Outcomes of Clinical Testing of the First 76,574 Patients Tested with myRisk
2. A Study of Triple-Negative Breast Cancer Patients Tested with myRisk
3. Assessment of the Clinical Presentation for Patients Discovered to have at Least Two Pathogenic Mutations
4. Multigene Panel Testing in an Unselected Endometrial Cancer Cohort
5. Prevalence of Germline Mutations in High Grade ER+/HER2- Breast Cancer Patients diagnosed
Analysis of results from 17,142 breast cancer patients tested with the 25-gene Myriad myRisk™ Hereditary Cancer panel reveals a 104% increase in mutations detected, compared with BRACAnalysis® alone.1
Outside BRCA1/BRCA2 (48.2% of mutations), the genes most commonly mutated were CHEK2, ATM and PALB2 (approximately 10% of mutations each). Mutations were also detected in seventeen other genes at lower frequencies.