Report is 1.5 years old but identifies a critical need for prostate tests to aid decision making.
The Coverage and Analysis Group at the Centers for Medicare and Medicaid Services (CMS)
requested that the Technology Assessment Program (TAP) of the Agency for Healthcare
Research and Quality (AHRQ) conduct an update of the horizon scan of genetic tests for cancer
conditions. AHRQ assigned this project to the Tufts Medical Center Evidence-based Practice
Center (Contract Number: HHSA 290 2007 10055 I, Task Order #11).
.Expects to Have First Test on Market Next Year
Development of Novel Liquid Biopsy-Based Cancer Tests
Presentations at SABCS and SUO Reveal Company's Ability to Detect Breast and Bladder Cancers in Blood and Urine, (GHDX) today announced positive results from its first two feasibility studies assessing multiple technologies, including next-generation sequencing, for their ability to detect and characterize the presence of bladder cancer DNA in urine and breast cancer DNA in blood.
The presentations of these initial encouraging results at the 2014 San Antonio Breast Cancer Symposium (SABCS) and the 2014 Society of Urologic Oncology (SUO) Annual Meeting represent an important milestone as Genomic Health pursues the development of standardized non-invasive tests that can provide an ongoing evaluation of a patient's cancer to obtain quantitative real-time insights to inform treatment planning throughout the cancer patient's journey, from diagnosis to treatment selection and monitoring. plans to develop a line of so-called liquid biopsy tests that can detect genetic evidence of cancer in a vial of blood.
.New evidence* supports a tool that might inform treatment decisions in women with low-grade breast tumors. Since the 1980s, diagnoses of DCIS (ductal carcinoma in situ) have risen dramatically due to enhanced screening. Questions about this condition – whether it’s likely to cause harm, and how to manage it – are central to debate about mammography, the concept of overdiagnosis, and overtreatment.
Investigators at the San Antonio Breast Cancer Symposium* presented results for Oncotype Dx (Genomic Health GHDX +2.56%) a molecular pathology test, for evaluating DCIS. The multi-gene DCIS assay yields a prognostic score for the likelihood that DCIS will recur or lead to invasive breast cancer.
A key finding is that a low Oncotype DX DCIS Score™ conferred a low chance of recurrent disease in the affected breast – around 12.7 percent – after lumpectomy alone, with a median follow-up of
9.4 years. This clear result has huge implications for women with DCIS. It suggests that many – and possibly most – women with this condition can safely forgo radiation after lumpectomy.
courtesy of Dr. E. Rakovitch, University of Toronto (abstract #$%$04, San Antonio Breast Cancer Symposium,
Tipping point , profitable this year . Reimbursement is what this is all about. That issue is currently before the FDA. Once a decision is published ,GHDX will take off
They say TV adds 10 lbs , Kim looks very different in person ..Maria too. there is a clip on foxbusiness
This article has interesting implications for GHDX.
However, this statement makes me believe that there is a place for tests such as those marketed by GHDX.
Monk, instead, views Foundation’s tests as more applicable in “desperate” situations: “We don’t profile [a tumor] for [hundreds] of genes, we profile it for what’s relevant to that tumor type and to those approved agents. And all of that other noise, I don’t know what it means.”
Boy, was your analysis accurate. It is a little over a month after the Street Hack Job and ALKS has exploded upwards. Cramer is for entertainment, not investment advice.
not to spread speculation or anything - ) look at Foundations rev etc, Look at GHDX. Icahn always likes to say - we aint selling cheap - the Bakers never do.
Giant drug developer Roche, mastermind of four Bay Area deals over the past year, will make its next big play by buying a majority stake in Foundation Medicine for about $1.3 billion.
The Swiss-based parent of South San Francisco's Genentech Inc. said late Sunday night that it would buy about 15.6 million shares of Cambridge, Mass.-based Foundation Medicine (NASDAQ: FMI) — or roughly 56.3 percent — in a $780 million tender offer. That is a 109 percent premium over FMI's closing price on Friday.
Roche also will spend $250 million for 5 million newly issued shares.
What's more, Roche has gobbled up four other local companies in the past year, capped by its $8.3 billion deal in the fall for Brisbane drug developer InterMune Inc. It also bit off DNA sequencing system developer Genia Technologies Inc. of Mountain View in the summer for $350 million, Redwood City sequenc
LDT regulations approaching - Following the enactment of the
In early 2015, GHDX & SQNM are expected to receive separate NGS codes for their Oncotype Dx and MaterniT21 tests, which, for SQNM in particular, should help facilitate reimbursement timelines.
While we expect 2015 should bring major developments in the FDA’s move to implement
risk based LDT regulations, though we believe established players a la GHDX, MYGN,
SQNM should be well positioned to comply with any additional reporting burdens. The
FDA is in the process of conducting public workshops (Jan 8-9, 2015) to discuss its
proposed regulations of LDTs.
agree 100% . The Bakers are first and foremost M&A specialists who want to make money for their clients , like Stanford U - ) Good Luck
That can be taken as a positive or a negative depending on your perspective. The Baker Bros continue to maintain control of around 45% of the share float. I don't believe they can exceed 50% without incorporating GHDX as a subsidiary. I suspect that they have control of more than 50% of the float which would make the small shareholder irrelevant for any major decision making. Thus far it has not been a problem since their interests appear to be aligned. However, what might happen if another company they had an interest in wanted to acquire GHDX? Sure there would be a long line of Class action attorneys lining up to sign up plaintiffs. However, that is almost always a good situation for the attorneys and not the share holders.
There is 0 evidence that this is a concern, just something to keep in the back of you mind.
As I have said numerous times, this is my favorite play for a likely deflationary environment. If GHDX executes this year in the manner they have guided us to expect, then we should be off to the races. Growth will be extremely hard to find if the deflationary forces accelerate. I suspect that is why the share price has held up reasonably the past couple of days. Of course the extremely high percentage of institutional and insiders probably limit the sell side volatility.
REDWOOD CITY, Calif., Sept. 25, 2013 /PRNewswire/ -- Genomic Health, Inc. today announced that the National Institute for Health and Care Excellence (NICE) in the United Kingdom has issued its final guidance recommending Oncotype DX® as the only multi-gene breast cancer test for use in clinical practice to guide chemotherapy treatment decisions for patients with early-stage, hormone receptor-positive, invasive breast cancer. Consistent with leading international breast cancer treatment guidelines, including ASCO®, NCCN®, ESMO ® and St. Gallen, NICE's recommendation recognizes the unparalleled evidence of the clinical validity of the Oncotype DX test and its ability to enable physicians and their patients to make more informed, individualized decisions.
Additionally, recent data presented at major medical meetings showed clinically meaningful
differences between patient results generated by the Oncotype DX breast cancer test and the
Mammaprint test, which unlike Oncotype DX was developed using a largely untreated patient
population that did not reflect the established standard of care of hormone therapy for patients
with estrogen receptor positive disease. Specifically, these results revealed that patients
stratified as high-risk by Mammaprint with high ER expression may lead physicians to
inappropriately offer treatment with chemotherapy.
We realize there is a lot of information in the market right now that can lead to confusion, and
we encourage you to ask the following questions when talking to companies who claim to offer
tests similar to Oncotype DX.
• What specific clinical question was the test developed to answer and is it relevant
to current practice?
• Were multiple randomized studies, including treated and untreated patients,
conducted to validate and reproduce the test’s ability to answer this question?
• What comprises test volume – is it commercial or research use?
• Are they getting paid routinely by private payors without appeal?
• For tests in kit form, like the one Nanostring is developing, what measures are
taken to ensure high, reproducible quality at local labs?
• Have they conducted prospectively designed, randomized trials with long term
clinical outcomes (i.e., 10 years or longer)?
• What is the pipeline opportunity and how is the company investing in it to drive
As the field of molecular diagnostics advances and new companies offering genomic-based
breast cancer tests emerge, a number of you have approached us with questions about how
these efforts compare to Oncotype DX® and our work at Genomic Health. We’d like to take this
opportunity to highlight the important distinctions that should be taken into consideration as you
evaluate these companies and their products.
The Oncotype DX Recurrence Score® was developed to answer the specific question of which
estrogen receptor positive (ER+) breast cancer patients need chemotherapy in addition to
hormonal therapy. To validate it for this specific purpose, Genomic Health and its collaborators
obtained practice-changing results from landmark clinical studies that included patients
randomized to treatment (so that both prognosis and prediction could be obtained) and followed
for long term outcomes. To date, it is the only test validated to predict who benefits from
chemotherapy, and the only test included in all major breast cancer guidelines (ASCO,NCCN)
for treatment decision making. As a result, it has been broadly adopted by the physician
community, widely reimbursed in the United States, and used to guide treatment in more than
350,000 breast cancer patients around the world.
From the 2013 An Rept
Our ability to compete and to achieve sustained profitability is impacted by our ability to protect our proprietary discoveries and technologies. We currently rely on a combination of issued patents, patent applications, copyrights, trademarks, and confidentiality, material data transfer, license and invention assignment agreements to protect our intellectual property rights. We also rely upon trade secret laws to protect unpatented know-how and continuing technological innovation. Our intellectual property strategy is intended to develop and maintain our competitive position. Patents may be granted to us jointly with other organizations, and while we may have a right of first refusal, we cannot guarantee that a joint owner will not license rights to another party, and we cannot guarantee that a joint owner will cooperate with us in the enforcement of patent rights. .....
There have been several cases involving "gene patents" and diagnostic claims that have been considered by the U.S. Supreme Court. In March 2012, the Supreme Court in Mayo Collaborative v. Prometheus Laboratories, or Prometheus, found a patented diagnostic method claim unpatentable because the relationship between a metabolite concentration and optimized dosage was a patent-ineligible "law of nature." In June 2013, the Supreme Court ruled in ACLU v. Myriad Genetics , or Myriad, that an isolated genomic DNA sequence is not patent eligible while cDNA is eligible. Both the Prometheus and Myriad decisions affect the legal concept of subject matter eligibility by seemingly narrowing the scope of the statute defining patentable inventions.
To me these paragraphs confirm my earlier statement, that confidentiality an maintaining strict control over the testing procedures are the primary means of protecting the intellectual property/technology.
Any thoughts about the recent Myriad ruling. In the case of the BRA or BRA2 tests the court appears to be re-affirming that MYGN can not patent the use of this genetic sequence for breast and ovarian cancer diagnostic purposes. How does this differ from GHDX's model. Sounds like the BRA sequence is well known and that the analyses of the sequence may not be exclusive to MYGN's lab facility. This is probably the result of the BRA gene test development in conjunction with the Univ. of Penn. Is GHDX's model fundamentally different by the fact that they have not specifically detailed and published the exact genomic sequence used to diagnose say prostate cancer aggressiveness? Is the intellectual property better protected by restricting the analyses of the OncoDX prostate tests to a single lab facility? My read is that if another company does its own research and comes up with a similar or the same genomic sequence they are will free to exploit it without fear of patent infringement suits. This is probably a strong reason for GHDX to restrict the number of lab facilities and to hold employees to to very strict non disclosure requirements.
I'll look through Annual Reports for more discussion.
Most analysts are attributing today's selloff to pricing pressure exemplified by Abbievie winning Express Script support for its HCV drug over Gilead's superior drug. This sell off carried over to GHDX. However, GHDX may be in the part of the biotech sector that does well going forward. As I have previously hypothesized, products that squeeze costs out of the system will be well positioned in the future. Biogeneric drugs and genomic testing are two areas that should do well.