Wednesday, December 7, 2022

Oncotype Dx Prostate Cancer Test

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What Does Oncotype Mean

Dr. Klein on Predicting Tumor Aggressiveness With Oncotype DX Test in Prostate Cancer

What do Oncotype scores mean? Oncotype DX is a test that predicts how likely breast cancer is to come back after surgery and the likely benefit of having chemotherapy. The test gives a score between 0 and 100, and people who score above a certain number are more likely to be offered chemotherapy . What is Oncotype testing?

What Is Oncotype Dx Testing

Oncotype DX tests are genomic tests produced by Genomic Health, Inc., which is now part of the company Exact Sciences. These tests can help medical professionals predict the future activity of breast cancer, prostate cancer, or colon cancer.

Genomic tests work by analyzing the activity level of certain genes found in cancer cells. Researchers have identified certain gene alterations linked to specific patterns of cancer development.

Medical professionals can use the results of your Oncotype DX test along with the results of other tests to predict:

  • whether you will benefit from chemotherapy or radiation therapy
  • the chances of your early stage cancer returning in a distant part of your body

Oncotype Dx Prostate Cancer Test 9/13

Genomic Health made its Oncotype DX prostate cancer test available recently after a presentation of a positive clinical validation study by the University of California, San Francisco, at this years American Urological Association annual meeting.

Results showed that the test, developed in collaboration with the UCSF and Cleveland Clinic, strongly predicted disease aggressiveness . The multi-gene test has been validated to guide treatment decisions using the prostate needle biopsy sample taken before the prostate is removed.

In the UCSF validation study of 395 patients, adding the biological information revealed by the tests Genomic Prostate Score significantly increased the number of patients identified as having very low-risk disease , making them appropriate candidates for active surveillance. More than one-third of patients originally classified as low risk based on clinical measures were identified by the GPS as very low risk and could confidently choose active surveillance. About 10 percent of patients originally classified as very low or low risk by clinical factors were identified by the GPS as having more aggressive disease.To develop the Oncotype DX prostate cancer test, Genomic Health conducted, in collaboration with the

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How To Prepare For An Oncotype Dx Test

You dont need to do anything specific to prepare for an Oncotype DX test. Its performed in a laboratory using the cancer cells from a biopsy or surgery. Ask your cancer care team when youre likely to learn the results of the test.

When it comes to preparing for your breast biopsy or surgery, your cancer care team will tell you what you need to know. Be sure to speak up and ask questions.

Breast cancer treatment: The care you need is one call away

Your multidisciplinary team will work with you to develop a personalized plan to treat your breast cancer in a way that fits your individual needs and goals.

Prostate Cancer Gene Expression Testing At Ucsf

About the Oncotype DX Genomic Prostate Score® Test

A major challenge in tailoring prostate cancer care is identifying men who require immediate or aggressive treatment and those who possess prostate cancers that can safely be surveyed. Several prediction tools have been developed and tested at UCSF including the CAPRA, and CAPRA-S scores. Recently, several commercially available genetic tests taken from an individuals prostate cancer tissue have become available that may assist urologists and patients in clinical decision making. UCSF Department of Urology has collaborated with Genomic Health, Inc and Myriad Genetics to evaluate genomic biomarkers, as well as conducted several independent studies of these markers.

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Independent Director Representing Qaly

Lieve Verplancke MD was nominated as an Independent Non-Executive Director at the Companys Annual General shareholders Meeting held on 26 May 2017 in Diegem, Belgium. Ms. Verplancke, a Belgian national, began her career in 1984 with The Beecham Group , and has since held key management positions with Merck & Co., as well as Bristol-Myers Squibb, where she served as Managing Director, leading their Belgian/GDL subsidiary, until 2012. Ms. Verplancke has also served as a Board Member for Brussels-based Europe Hospitals the Imelda Hospital in Bonheiden and the Euronext fund, Quest for Growth and Materialise. She is also the Founder and Managing Director of Qaly@Beersel, an elderly care center in Belgium. In addition to being a medical doctor , Ms. Verplancke holds a postgraduate degree in Economics and an MBA from the University of Antwerp. She has also completed courses at INSEAD, CEDEP, Columbia University and the Vlerick Business School, and is a certified Executive Coach .

Breast Cancer Oncotype Dx Tests

There are two types of Oncotype DX testing for breast cancer.

  • Oncotype DX Breast Recurrence Score test: helps predict the benefit of chemotherapy and risk of distant cancer reoccurrence in people with early stage estrogen receptor-positive and human epidermal growth factor receptor 2-negative breast cancer.
  • Oncotype DX Breast DCIS Score test: provides predictive information about the 10-year reoccurrence rate and benefit of radiation therapy in people with early stage ductal carcinoma in situ cancer
Oncotype DX Breast Recurrence Score Test eligibility

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Chief Executive Officer Director

Mr. McGarrity has more than 25 years of experience in the healthcare industry with a unique combination of device, diagnostics and biotechnology experience. Michael was most recently the CEO of Sterilis Medical. Prior to Sterilis Michael was the CEO of Nanosphere , a nanotechnology-based molecular diagnostics company, where he engineered an operational and strategic turnaround that resulted in its successful sale to Luminex in 2016. Prior to Nanosphere, McGarrity spent 13 years at Stryker Corporation . McGarrity served in leadership roles in sales and marketing and led Stryker into new growth markets such as post-operative pain management, surgical fluid waste management and interventional pain management. He also had executive general management responsibility for a newly created business unit focused on interventional spine pain management. Michael received a Bachelor of Arts degree from the University of Notre Dame and began his career in commercial banking.

How Accurate Is Oncotype Dx Testing

Dr. Febbo Explains the Oncotype DX Genomic Prostate Score

Many studies have validated the accuracy of Oncotype DX testing for invasive breast cancer. The NCCN guidelines list the level of evidence of Oncotype DX testing for predicting chemotherapy benefit in postmenopausal women as level 1, which is the highest level.

Level 1 evidence means the researchers are basing their opinion on the results of reviews of randomized controlled trials, the gold standard for evaluating a tests validity.

The NCCN lists the level of evidence in premenopausal women as 2A, meaning the recommendation is based on review of cohort studies, or studies following a group of participants over a period of time.

Fewer studies have validated the accuracy of Oncotype DX testing for prostate and colon cancer.

A 2021 study performed by the American Society of Clinical Oncology found that Oncotype DX testing may help predict the 20-year risk of prostate cancer-specific mortality and the chances of distant spreading.

The first study providing validation of Oncotype DX testing stage 2 and 3 colon cancer was called the SUNRISE study. The study found evidence to support the predicting capabilities of Oncotype DX testing and the ability of the test to help medical professionals predict future cancer activity.

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Executive Vice President Of Operations

Miriam Reyes has 25 years of experience in life science and laboratory operations, and R& D. She has served as Operations Leader at MDxHealth since its US inception in 2011. Prior to MDxHealth, Mrs. Reyes was Director of Laboratory Operations at Agendia where she established/built and led the CLIA lab for the Agendias FDA cleared MammaPrint breast cancer test. In addition to Agendia, she established laboratory operations at Combimatrix Molecular Diagnostics and developed commercial assays at both IBIS Biosciences and US Labs .

A Genetic Biomarker Test For Newly Diagnosed Prostate Cancer

Results from a study of a different genetic biomarker test suggest that it could one day help inform treatment decisions for men newly diagnosed with localized prostate cancer.

According to findings published February 24 in JCO Precision Oncology, a biomarker test called the Oncotype DX Genomic Prostate Score accurately predicted the long-term risk of metastasis and death from prostate cancer in men with localized disease. The test needs to be validated in larger forward-looking studies before it can be used to guide treatment, the study researchers noted.

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Independent Director Representing Regine Slagmulder Bv

Dr. Regine Slagmulder is a partner and full professor in management accounting & control at Vlerick Business School. Previously, she worked as a strategy practice consultant at McKinsey & Company. She also previously worked as a professor of management accounting at INSEAD and at the University of Tilburg. She serves. as an independent director and chair of the audit committee on the board of the investment company Quest for Growth. and of Ekopak , both listed on Euronext. Dr. Slagmulder graduated in civil electrotechnical engineering and industrial management from the University of Ghent, after which she took a management doctorate at Vlerick Business School. As part of her research activities, she was a research fellow attached to INSEAD, Boston University and the P. Drucker Graduate Management Center at Claremont University .

Other Types Of Cancer Oncotype Dx Can Test For

Interpreting Oncotype DX GPS(TM) Results

While the Oncotype DX Breast Cancer Recurrence Score is the most widely known test, theres also an Oncotype DX Prostate test for prostate cancer.

Similar to the breast cancer test, it uses information from genes in cancer cells to make predictions about the disease. The prostate test may help determine how likely the cancer is to spread quickly.

Oncotype DX tests also exist for certain types of colon cancer and of advanced, recurrent or difficult-to-treat cancers.

Gene expression tests such as the Oncotype DX tests are a relatively new tool in the fight against cancer, and they are proving to be important catalysts in preventing unnecessary chemotherapy treatments. Additional gene expression tests for different types of cancers are currently being studied and may continue to be developed, increasing the opportunity for individualized cancer treatment in the future.

Expert cancer care

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Genomic Tests Assess The Molecular Architecture Of Cancer

The assay, known as Oncotype DX® Genomic Prostate Score , was developed by Cleveland Clinic researchers in partnership with Exact Sciences over a decade ago. The goal was to use high-end genomic technology, the same technology used to sequence the human genome, to identify molecular features of prostate cancer.

This was the first time we created tools that allow us to directly assess the molecular architecture of early-stage prostate cancer in a way that it couldnt be assessed before, explains Eric Klein, MD, urologic oncologist and Chairman Emeritus of the Glickman Urological & Kidney Institute.GPS is a diagnostic tool that allows urologic oncologists to personalize a patients course of treatment based on the tumors biology as measured by gene expression profiling. It helps identify candidates for active surveillance versus candidates for immediate therapy. Genomic testing in conjunction with an MRI is a standard of care in the evaluation of prostate cancer at Cleveland Clinic.

But the longer-term implications of these data points have been largely unknown until recently. The JCO Precision Oncology study, led by Dr. Klein, is the first report to evaluate the predictive ability of GPS using long-term outcomes data.

Why Get The Oncotype Dx Genomic Prostate Score Test

If you have been diagnosed with low-risk prostate cancer, discussing management options with your doctor is typically the next step. Its important that you give yourself time to understand what your diagnosis means, and what option will be best for your specific cancer at this specific time.

The Oncotype DX test gives you and your doctor more information for treatment conversations and decisions.

Oncotype DX is a genomic test, meaning that it measures the expression of certain genes in prostate cancer cells. The results of Oncotype DX are reported as a Genomic Prostate Score , which can help you and your doctor more confidently make decisions about a management plan thats best for you.

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Talking To Your Doctor About The Gps Test

Like other lab tests, the GPS test must be ordered by a licensed healthcare provider . Whether you decide to get the test or not, youll certainly have a lot to talk with your doctor about.

Here are some questions you may want to ask:

  • I understand that my prostate cancer is early stage and localized. What are my treatment options? What do you suggest for me and why?
  • What are the benefits of each treatment option? What are the drawbacks/side effects of each one?
  • How long do side effects of each treatment option last? Do they go away once treatment is complete?
  • Is it okay to wait a few weeks to consider my treatment plan options before I have to make a decision about treatment?
  • What are the chances of my cancer coming back if I choose to have surgery?
  • What are the chances of my cancer coming back if I choose to have radiation?
  • Am I a candidate for the Genomic Prostate Score test?
  • What is a Gleason score?
  • If I am a candidate for the GPS test, how could we use the test results to develop my treatment plan?
  • How can I get a copy of my pathology report and my GPS test results ?

About Oncotype Dx Genomic Testing

Dr. Katz on Redefining Risk Assessment in Prostate Cancer With 17-Gene Oncotype DX GPS

Oncotype DX tests help doctors predict the future activity of cancer by analyzing genes in samples of breast, prostate, or colon cancer cells. The test results can help determine the risk of metastasis, which is when cancer appears or returns to a distant part of the body. They can also help predict the potential benefits of chemotherapy or radiation therapy.

A large amount of research supports the use of Oncotype DX testing for predicting the future activity of invasive breast cancer.

In their latest guidelines, the National Comprehensive Cancer Network lists the Oncotype DX Breast Recurrence Score as their preferred gene expression test for predicting future chemotherapy benefits in those with breast cancer.

There are fewer studies validating the use of Oncotype DX testing for colon and prostate cancer, but clinical trials have found promising results.

In this article, we break down everything you need to know about Oncotype DX tests, including how to interpret your results, the benefits, and the procedure.

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What Are Genomic Tests

Genomic tests analyze a sample of a cancer tumor to see how active certain genes are. The activity level of these genes affects the behavior of the cancer, including how likely it is to grow and spread. Genomic tests are used to help make decisions about whether more treatments after surgery would be beneficial.

While their names sound similar, genomic testing and genetic testing are very different.

Genetic testing is done on a sample of your blood, saliva, or other tissue and can tell if you have an abnormal change in a gene that is linked to a higher risk of breast cancer. See the Genetic Testing pages for more information.

Tests Prior To Treatment

Two biopsy based tests of prostate cancer tissue have received clinical study and are commercially available: the OncotypeDXGPS and Prolaris assays. The Oncotype DX® test was developed by Genomic Health, Inc that analyzes tissue samples obtained at the time of diagnosis from the portion of a prostate biopsy containing cancer. The Oncotype® test was developed by studying 727 genes believed to be involved in the development of prostate cancer. These were ultimately refined to a signature of 17 genes that are associated with a likelihood of having high grade and/or high stage if the prostate is removed and examined. In studies performed at UCSF, this 17-gene signature was a reliable and helpful tool in assessing candidates for treatment or active surveillance without re-sampling or removing the entire prostate.

This tissue-based test requires no additional biopsy because the specimen is taken from an individuals existing biopsy, and can generate a result from as little as 1mm of cancerous tissue. OncotypeDX® yields a Genomic Prostate Score , on a scale of 1-100, where higher scores are more suggestive of adverse pathology. It is important to remember that a GPS score is a measurement of gene expression within prostate tumors and must be interpreted within the context of other relevant clinical factors.

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Changing Practice Removing Clinical Subjectivity

This study further solidifies genomic testing as a mainstay in the management of prostate cancer. Its ability to discriminate tumors molecular features can guide management strategies. Tumors with lower, more favorable scores can be carefully watched while higher, more concerning scores may warrant additional diagnostic procedures, closer follow-up or immediate treatment.

Dr. Klein says the data from this recent publication helps remove some clinical subjectivity. These data indicate that decision-making can be dichotomized. Either youre a good candidate for surveillance, or youre not.

He continues, noting that this study is more evidence that genomic tests provide clinically meaningful data. The validity of these tests is well-documented, but we are starting to discover their clinical implications in the context of long-term outcomes and this study shows the 20-year follow-up data to corroborate that.

Chairman And Independent Director Representing Ahok Bv

Tests Oncotype DX

Koen Hoffman has served as Independent Chairman of the Board of Directors of Fagron NV since May 8, 2017. He obtained a Master in Applied Economics at the University of Ghent in 1990 and a Master in Business Administration at Vlerick Business School in Ghent in 1991. Mr. Hoffman was appointed Chief Executive Officer of Value Square in August 2016. Prior to joining Value Square, he was Chief Executive Officer of KBC Securities, member of the supervisory board of Patria Securities and member of the board of directors of Omnia Travel Belgium. He started his career at the corporate finance department of KBC Bank in 1992.

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