PerspectiveRSS

Popovits Says Genomic Tests Individualize Cancer Care

Fri, 15 Apr 2011 16:23:00 -0700

Click here to view the interview and learn more about Genomic Health's perspective on genomics in cancer and current business highlights.

Harnessing the Power of Social Media to Share Critical Information with Patients

Fri, 18 Feb 2011 16:10:00 -0800

Despite multiple clinical trials, inclusion in breast cancer treatment guidelines, widespread reimbursement and the proven ability to change treatment decisions approximately 30 percent of the time with most resulting in less chemotherapy use -- only half of the patients who are eligible for Oncotype DX get the test¹. The other half are making a critical treatment decision without knowing the underlying biology of their own breast cancer, information that cannot be obtained any other way.

In an effort to empower patients to take an active role in their treatment decisions, Genomic Health created "Pass It On… Until Every Woman Knows," an online educational effort using social networks to spread the word about personalized breast cancer treatment planning not only to patients, but also to the many people in their lives who are their sources of information.

Campaign Reach

In the first three months – from October through December 2010, the Pass It On video was viewed over 57,000 times, UntilEveryWomanKnows.com was visited by nearly 56,000 unique visitors & approximately 46,000 members have joined the Pass It On facebook community.

Join the effort and Be the One to Pass It On... Until Every Woman Knows

Visit the Pass It On website: http://www.untileverywomanknows.com/ and share the video
Like the Facebook page: http://www.facebook.com/UntilEveryWomanKnows
Follow the campaign on Twitter and retweet our messages: http://twitter.com/passitonuntil
Share the video from Facebook and/or YouTube: http://www.youtube.com/untileverywomanknows

Video

Watch the 90-second Pass It On video clip and learn why Coree, Susan and Katherine want you to Pass It On...Until Every Woman Knows!

¹U.S. patients

A first-of-its-kind diagnostic test opens the door to personalized medicine in colon cancer

Tue, 16 Mar 2010 00:00:00 -0700

Genomic Health’s new Oncotype DX® Colon Cancer Assay is now available for patients diagnosed with stage II disease. This test looks at the activity of 12 genes within a patient’s tumor to assess the likelihood that the patient will experience a recurrence of their disease within three years of diagnosis. This information, in turn, can aid patients and their physicians in determining whether or not aggressive treatment such as chemotherapy is appropriate following the surgery to remove the tumor.

Oncotype DX is the first test of its kind for colon cancer patients, and while Genomic Health is excited to add a second diagnostic test to its portfolio, we believe the availability of this new test signals something much more important: the beginning of a new era in the treatment and management of colon cancer, as personalized medicine becomes a reality in this disease state.

Advancing the Dialogue Beyond Screening and Treatment

For years, Katie Couric and other public figures have emphasized the importance of colon cancer screening, urging Americans to get screened since this is one of the few cancers that can be prevented. These communication efforts have broken the silence on both colonoscopies and colon cancer, helping erase the stigma around the screening process and the disease itself.

On the other end of the spectrum, there has been a significant increase in the number of treatment options for colon cancer patients over the last decade, as several ground-breaking therapies and new treatment combinations have been developed, following a lag of nearly 20 years.

Despite these advances in the areas of screening and treatment, helping patients get a more personalized and precise diagnosis has been largely ineffective until recently. This is no small issue, particularly for the 30,000 – 40,000 Americans who are diagnosed with stage II colon cancer each year. For this patient population, it is not clear which patients should receive chemotherapy after their tumor has been surgically removed, and which patients will fare well without undergoing that systemic treatment.

This is a significant dilemma because approximately 20 percent of these patients will eventually experience a recurrence of their disease, despite what appears to be an initial cure with surgery alone. While some patients receive chemotherapy following surgery, determining which patients should most appropriately be treated has been a major challenge. As a result, some of the patients who could potentially benefit from chemotherapy are slipping through the cracks while others may be over-treated and exposed to unnecessary toxicity.

Pioneering a New Paradigm

With such a clear need for better tools to help physicians identify which colon cancer patients are at the highest risk of experiencing a disease recurrence – and therefore may benefit from more aggressive treatment – Genomic Health decided years ago to build on its breast cancer research, and use that expertise to develop a new diagnostic test for early stage colon cancer patients.

A decade of research on the genomics of cancer has taught us that the information contained within the biology of the tumor is vital to understanding how that cancer is likely to behave and progress. While it is important to use novel genomic testing in concert with traditional clinical observations such as tumor pathologic features and the patient’s lymph node status, relying on clinical observations alone does not reveal the entire story.

Through our years of colon cancer studies we have identified 12 genes whose combined behavior can accurately and reliably predict an individual patient’s risk of recurrence. And in addition to this important discovery of the 12 genes, our research has also confirmed what we understand to be a key role of two other markers: T-stage and Mismatch Repair (MMR).

We’ve learned that a higher T-stage, specifically T4 stage, in colon cancer is predictive of aggressive disease and therefore is associated with a higher likelihood of recurring. Conversely, a stage II colon tumor that is identified by laboratory testing as Mismatch Repair deficient is a good prognostic sign, since those tumors tend to be less aggressive and less likely to recur.

With the introduction of the Oncotype DX Colon Cancer Assay – and with our enhanced understanding of the role of T-stage and MMR – it is now possible to more accurately classify and differentiate these colon cancer tumors, because of this fundamental new diagnostic paradigm. For the first time, stage II colon cancer patients and their physicians have a genomic tool that enables them to better understand the complex inner workings of their individual tumors, opening the door to personalized medicine for patients with colon cancer.

Why Healthcare Reform Must Not Overlook Medicare’s Current Barriers to Timely Lab Testing

Tue, 22 Dec 2009 00:00:00 -0800

While the battle in Washington DC on healthcare reform continues, there is one lesser-known provision impacting Medicare patients that we believe is crucial to ensuring those beneficiaries have timely access to cutting-edge genomic and molecular diagnostic tests.

The Senate’s Health Reform bill H.R. 3590, The Patient Protection and Affordable Care Act, includes an important section that, if enacted, will reverse a current policy which can create a delay in medical decision-making and the initiation of treatment for millions of Medicare beneficiaries, simply because of an obstacle known as the Medicare “Date of Service” rule.

The Date of Service rule impacts all Medicare patients who undergo hospital procedures where blood or tissue samples are collected for testing, as often happens when a patient is being evaluated for a disease or condition. Under current Medicare regulations, any laboratory which is independent from the hospital that initially collected the patient's blood or tissue, must bill that hospital for any testing that it subsequently performs on those samples. This means that the hospital is expected to pay the lab and then turn around and bill Medicare for the lab's testing services, rather than allowing the lab to directly bill Medicare.

Strangely, this regulation remains in effect even after the patient has left the hospital and gone home, and the labs must continue to bill the hospital for their testing services unless the test is ordered 14 or more days after the patient has been discharged. Additionally, there is no medical basis for limiting labs from directly billing Medicare until 14 days after discharge. No other service - such as an MRI or PET scan - is required to be billed back to the hospital after the patient has gone home.

The result of this regulation is that the hospital must take on the financial, administrative, and professional responsibility for a test that has been ordered and performed outside the hospital after the patient’s hospital stay has ended – frequently when the hospital has no relationship with the laboratory, and in some cases may not even have a relationship with the physician who ordered the test. Often, the hospitals have responded to this situation by waiting at least 14 days after a patient’s discharge before releasing their blood or tissue sample to the lab, so that the test will be conducted outside the arbitrary Medicare timeframe.

This delay, in turn, can negatively impact timely patient access to laboratory services by creating barriers for the Medicare beneficiaries who need the critical information that comes from these tests. The unnecessary delay caused by the Date of Service rule may also exacerbate patients’ anxiety while they wait an additional two – four weeks for their test results.

However, H.R. 3590 will allow laboratories that offer advanced diagnostic testing to bill Medicare directly, without forcing the already over-burdened hospital into a “middleman” role it does not wish to assume and for which there is no clinical policy rationale. H.R. 3590 will also remove a disincentive that laboratories often face when developing new tests, because there is currently no assurance that they will receive payment from the hospital for medically-necessary tests performed for Medicare patients, if those tests fall within the 14 day window of a hospital admission or outpatient encounter.

We believe the inclusion of this legislative fix to the Date of Service rule within the over-arching healthcare reform efforts will significantly help Medicare patients take advantage of advances in laboratory medicine. Such advances are enabling healthcare providers to be far more effective in targeting treatment for individual patients, and in determining a patient’s predisposition to a specific disease or condition. Many of these diagnostic tests are helping to save lives, and some are also saving on the cost of delivery of care by helping to identify appropriate treatment for each patient, rather than treating them with a “one-size-fits-all” approach.

Genomic Health believes that a truly reformed healthcare system will ensure that Medicare beneficiaries – in many cases, patients who have limited financial resources – can more easily benefit from innovative, advanced diagnostics that have the potential to guide treatment planning and improve patient outcomes.

The Three Essential Components of Healthcare Reform

Wed, 30 Sep 2009 00:00:00 -0700

With U.S. healthcare costs spinning out of control and an increasing number of people losing their medical coverage as a result of rising unemployment, Genomic Health® agrees with President Obama’s assessment that some kind of healthcare reform is necessary. The core belief that inadequate health insurance should not prevent patients from accessing critical healthcare resources resonates deeply with Genomic Health, where we work closely with cancer patients and insurers to eliminate any financial barriers to obtaining our Oncotype DX® Breast Cancer Assay.

However, trying to shape healthcare reform so that all Americans have access to quality care while retaining some freedom of individual choice and bringing down costs is a complex, arduous, and lengthy process at best. While we at Genomic Health do not have the solution to the many issues and trade-offs that effective and comprehensive healthcare reform needs to address, we believe there are three essential tenets that elevate the role of personalized medicine that must be a part of the package that is ultimately adopted.

These three recommendations are based on the unique experiences of our founding team of scientific experts – still actively leading the company – who started Genomic Health with the vision that gaining insight into the behavior of cancer tumors at the molecular level would enable us to tailor treatments to each patient based on the biology of his or her disease. Each of these experts brought with them several decades of work at other highly successful genomic and biotech drug discovery companies, including research on novel therapeutics such as Pulmozyme® for cystic fibrosis, Herceptin® for metastatic breast cancer, and Avastin® for colon cancer.

Incentives for Innovative Research With this rich scientific history, we believe the first component of enhancing personalized medicine within a new healthcare system relies upon supporting innovative research, so that the potential of personalized medicine can be advanced. By doing so, our system will enable an ongoing flow of personalized therapies, developed in concert with genomic and genetic diagnostic tests, that help identify the most appropriate treatment for each patient at each stage of their disease, rather than using our current system of “trial and error” or “one-size-fits-all” medicine.

In the case of cancer, many physicians try to tailor each patient’s treatment through the routine use of medical tests to learn more about the physical aspects of his or her disease, such as tumor size and location. But there are only a limited number of tests that can actually “personalize medicine” when it comes to examining cancer on a molecular level and making treatment decisions accordingly.

Thus, innovation must be encouraged to bring new researchers and new resources to the field, ultimately resulting in more tools that can help us achieve the best and most cost-effective results with the fewest side effects and greatest quality of life for patients. Adopting this model also means our current research system must transition from the concept of developing “blockbuster” therapies to developing treatments that work on specific sub-populations of patients based on their genomic profiles.

Incentives for Data Collection of Patient Results

The second essential ingredient is the importance of data collection and the reporting of patient results so that we can harness the learnings from our research and build on those discoveries to support the advancement of personalized medicine. Support for the adoption of electronic health records and data collection is already underway and is an opportunity to help us learn from the day-to-day practice of medicine, so that we can evaluate and promote best practices that truly make a difference in patient care while eliminating treatment approaches that are no longer effective.

Another important learning opportunity comes from the collection and study of patient’s tissue and blood samples, so scientists can continue to perform research on a specific disease long after the patient has been treated and perhaps even cured. When done the right way, tissue collection also allows researchers to look for trends within patient care, and to correlate those trends to outcomes. In the case of personalized medicine, we can examine tissue samples to better understand the mechanism of disease based on the behavior of certain genes, and how those genes interact to intensify a disease in some patients while responding to treatment in others.

Support for Personalized Medicine

The third critical piece of advancing personalized medicine relates to the retention of incentives that foster innovation and reward researchers and companies that develop new therapies based on the genomic specifics of disease. By so doing, the reformed healthcare system would be able to manage its resources better and help eliminate the over- and under-treatment of patients, while keeping intact our country’s worldwide lead in medical science.

When implemented in a thoughtful way that avoids stifling innovation and scientific visionaries, healthcare reform and its goals of universal access, quality improvement, and cost control are not incompatible with biomedical innovation that is focused on personalizing the diagnosis, management, and treatment of disease. On the contrary, new, more effective medicines – along with new devices and diagnostic tools, better treatments and surgical techniques – will help us achieve better patient outcomes, leading to a healthier, more productive society.

Pulmozyme, Herceptin, and Avastin are registered trademarks of Genentech, Inc.

The Clear Need for a Strong(er), Independent Testing Industry as Demand for Companion Diagnostics Grows

Wed, 20 May 2009 00:00:00 -0700

This is an exciting time in healthcare, filled with new scientific discoveries that are fueling hopes for better treatments and quicker cures. Research and technology have significantly advanced our understanding of disease through the sequencing of the human genome. Patients are already beginning to benefit from the development of tools that have allowed treatment to evolve beyond the era of "one-size-fits-all", truly beginning to personalize medicine and treatment planning.

But this is also a challenging time in healthcare. This surge in genomic technology is colliding with a worldwide economic downturn, our nation’s soaring healthcare costs, and increased political movement toward comprehensive healthcare reform. These forces are converging, brewing a "perfect storm" – and the growing need for personalized medicine is at the eye of that storm.

Today our healthcare system is riddled with inefficiency and wasteful spending - one example of this is that the efficacy rate of many prescription drugs hovers around 50%. For cancer patients, the news is even bleaker, with oncology therapeutics working only about 25% of the time.* In stark contrast, many of those cancer patients are experiencing toxic side effects for costly therapies that may not be working. Viewed another way, nearly all of these patients are suffering from the side effects of these medicines- not to mention the toll on patients’ quality of life and the anxiety of figuring out how to pay for cancer care - but the treatments are only working about one-quarter of the time. Any way you look at it, that’s a poor return on our investment - as patients, as healthcare providers and researchers, and as a society.

This imbalance between high treatment costs and low therapeutic efficacy is often a result of treating a specific diagnosis one way across a diverse patient population. But with the advent of gene profiling tools, genomic testing, and advanced diagnostics, this is beginning to change. Research in this area is accelerating, and we are starting to see an increase in the diagnostic tools that are available to help us pinpoint which patients are likely to derive benefit from specific therapies, so that physicians can begin to better tailor treatments to their patients.

Historically, we have relied on a model that charged the pharmaceutical and biotech industries with developing the companion diagnostics for their therapies - tests that identify which patients are most likely to benefit from the drugs they commercialize, while ruling others out. However, it has not escaped the notice of these companies that personalizing treatment plans based on the individual biology of each patient’s disease may shrink their potential markets and ultimately hurt their bottom-lines.

While we can appreciate this dilemma, the ineffectiveness of our healthcare system’s current approach to disease management is linked to this inherent conflict of interest within the biotech and pharmaceutical industries: their primary business objective is to sell drugs and keep those numbers increasing each quarter - their business is not based on identifying likely non-responding patients (or those at risk for adverse events) who will then be prescribed another company’s treatment.

Therefore, to continue to propel advances in diagnostics, it is clear that we need a strong, independent testing industry, so that genomic discoveries will be translated into meaningful tests that enable us to get the right therapy to the right patient at the right time. Equally evident is the fact that the testing industry will need to work collaboratively with the pharmaceutical and biotech industries, so that research on new diagnostics is done in parallel with the development of new therapeutics. Ideally, we will reach a time when many new therapeutics will have a companion diagnostic test, so that we will be better able to identify the patients most likely to benefit as those new treatments come to market.

This in turn can lead to more accurate diagnoses and improved outcomes, while increasing the quality of healthcare and lowering costs - in other words, healthcare that is truly patient-centric. Because after all, the heart of the personalized medicine revolution is all about providing more effective, more individualized patient care.

*Source: Brian B. Spear, Margo Health-Schiozzi, and Jeffrey Huff, "Clinical Application of Pharmacogenetics." Trends in Molecular Medicine (May 2001)