Posts (47)

Jul 24, 2014 · Roundtable Discussion on 21st Century Cures


 

The chair of the Mayo Clinic Department of Laboratory Medicine and Pathology, Frank Cockerill, M.D., participated yesterday in a roundtable discussion, hosted by the U.S. House of Representatives Energy and Commerce Committee. This was the third roundtable discussion in the 21st Century Cures initiative.

“We know that many advancements in science and technology have been made that can lead to more successful developments and treatments in cures.” Rep. Diana DeGette (D-CO)stated, “As we learn more about the science, we can target potential treatments and cures more effectively on impacted populations.”

Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) led the discussion on personalized medicine with participants from the U.S. Food and Drug Administration, the Ovarian Cancer Society, Leukemia and Lymphoma Society, MD Anderson, Duke University Health System, Genentech, Mayo Clinic, American College of Cardiology, Abbott Molecular, the Personalized Medicine Coalition, and Apple Tree Partners. Participants discussed how advances in areas such as genomic sequencing and diagnostic testing can accelerate the pace of cures.

“21st Century Cures touches all Americans as they, their families, or their friends have been affected by disease. Through our work on this initiative, we have found that much hard work remains to finding and delivering cures and treatments for the approximately 95 percent of diseases without them. But we’ve also seen an outpouring of support and enthusiasm to work together and achieve this common goal,” commented Chairman Upton. “We also know that every patient is different and that we need to foster innovation to better understand those differences and find the best treatments for each patient.” 

 

For more details from the hearing and the opening statement, please click here.

 

 

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Jul 8, 2014 · Missouri is 19th State Signing Breast Density Bill into Law

As of today, women in 31 states leave their yearly mammogram appointment without the knowledge of their own breast density number. This single data point is important in tailoring personalized care for each woman, and assisting in possible further preventative care.

Are You Dense, Inc. released a press release announcing the passing of the 19th state bill, which made into law in the state of Missouri, to include breast density information in a patient’s mammography reporting results.

Too many women are unaware of the effects of breast density, but this knowledge can save lives by leading to earlier breast cancer detection,” notes Representative Sue Allen of Missouri.

Hitting closer to home here at the Center for Individualized Medicine, Deborah Rhodes, M.D., has been working with a team of researchers to develop a new tool that is 3 times as effective as traditional mammograms for women with dense breasts. By offering another option for cancer detection, Dr. Rhodes, and the team at Mayo Clinic, are creating more individualized options that can help with early detection of tumors in the breast.

Watch Dr. Rhodes speaking at TEDTalks on the research being done at Mayo Clinic, and the story behind the work.

 

 

 

 

Jul 1, 2014 · Biomarkers 101 Part 2

Biomarkers 101 Part 2

 

 

George Vasmatzis, Ph.D., and John Cheville, M.D., co-directors of the Biomarker Program at the Center for Individualized Medicine at Mayo Clinic, introduce us to the world and work of Biomarkers.

The Biomarker Discovery Program is a multidisciplinary team that includes oncologists, surgeons, pathologists, molecular biologists, bioengineers, bioinformaticians and others. By combining expertise, the program takes a clinical question, and answers it through a four-phase approach: Discovery, experimental validation, preclinical validation and clinical validation.

The Co-Directors answer the following three questions in this video:

  1. How do you identify a Biomarker?
  2. What projects are you currently working on?
  3. What are some challenges you face?

 

Discover the latest in Biomarkers, and Genomics, at our annual Individualizing Medicine Conferencethis year, October 6-8!

 

 

 

Jun 26, 2014 · Non-Hodgkin Lymphoma New Routine Testing

Article Originally Featured on the Mayo Clinic News Network.

A Mayo Clinic-led group of researchers has discovered three subgroups of a single type of non-Hodgkin lymphoma that have markedly different survival rates. These subgroups could not be differentiated by routine pathology but only with the aid of novel genetic tests, which the research team recommends giving to all patients with ALK-negative anaplastic large-cell lymphoma (ALCL). Findings are published in the journal Blood.

 

 

Patients whose lymphomas had TP63 rearrangements had only a 17 percent chance of living five years beyond diagnosis, compared to 90 percent of patients whose tumors had DUSP22 rearrangements. A third group of tumors, those with neither rearrangement, was associated with an intermediate survival rate.

“This is the first study to demonstrate unequivocal genetic and clinical heterogeneity among systemic ALK-negative anaplastic large-cell lymphomas,” says Andrew L. Feldman, M.D., a Mayo Clinic pathologist and senior author on the multi-institutional study. “Most strikingly, patients with DUSP22-rearranged ALCL had excellent overall survival rates, while patients with TP63-rearranged ALCL had dismal outcomes and nearly always failed standard therapy.” Dr. Feldman also is a Damon Runyon Clinical Investigator.

ALCL is a rare type of non-Hodgkin lymphoma, but one of the more common subtypes of T-cell lymphoma, according to the Lymphoma Research Foundation. ALCL comprises about three percent of all non-Hodgkin lymphoma and 10 to 30 percent of all cases in children. Currently, all ALK-negative anaplastic large-cell lymphomas are treated the same, using chemotherapy and, in some institutions, stem cell transplantation. Results from the study make a clear case for additional testing and possible changes standard of care.

“This is a great example of where individualized medicine can make a difference,” says Dr. Feldman. “Patients whose chance of surviving is 1 in 6 are receiving the same therapy as patients whose odds are 9 in 10. Developing tests that identify how tumors are different is a critical step toward being able to tailor therapy to each individual patient.”

TP63 and DUSP22 rearrangements are examples of abnormal swapping of DNA that disturbs the way genes are arranged on a tumor cell’s chromosomes. These abnormalities cannot be seen in the standard microscopic evaluation that pathologists use to diagnose lymphoma, but can be visualized using a genetic test called fluorescence in situ hybridization (FISH). The authors of the study recommend performing FISH in all patients with ALK-negative anaplastic large-cell lymphoma. Learn more about the new tests:

 

 

Jun 25, 2014 · Difficult Decisions with Genetic Testing

Ethical Decisions

 

When dealing with the findings that having your genome sequenced brings, patients have predominantly been given the choice of either all the information or none at all.

In March 2013, the American College of Medical Genetics and Genomics (ACMG) released recommendations on how to handle incidental findings (IFs) for the clinical application of whole exome or whole genome sequencing (WES/WGS). The ACMG recommended that clinical laboratories “actively search,”evaluate, and report pathogenic or likely pathogenic variants in 56 genes and report these findings to the ordering clinician, who could then “contextualize any incidental findings for the patient in light of personal and family history, physical examination, and other relevant findings.”

The 2013 recommendations did not provide guidance for laboratories to offer patients of any age the ability to opt out from the reporting of IFs. The 56 genes are associated with 24 genetic cardiovascular disorders or predisposition to cancers for which confirmatory diagnostic approaches are available as well as some preventive or treatment measures that can be offered. The ACMG recommended further that those who did not agree to learn of these IFs could choose to forego the entire test. These recommendations generated much controversy, most of which focused on patients’ ability to opt out of receiving unwanted results.

“Patients say that being able to have a say in what they learn or don’t learn is really kind of important,” said Jennifer McCormick, from the Bioethics Program at the Center for Individualized Medicine.

Much is known about how individuals respond to learning about genetic risk information, but the bulk of those data is from individuals undergoing single-gene testing. These experiences with single-gene testing may not be a fair comparison to WES/WGS testing. With the former, a person knows what is being tested and has sought the test to determine his or her risk for carrying genetic variants causing the disease.

In contrast, WES/WGS is not selective, and the results may reveal much more information than originally desired or anticipated. The landscape has changed appreciably, and it is no longer clear what it means to be well prepared to get results from clinical WES/WGS. These issues require additional study in well-designed clinical trials to understand more about the risks and benefits of receiving information on IFs. This is especially true for the release of IFs to children and their parents.

The vibrant discussions that have ensued since the release of the 2013 ACMG recommendations are encouraging, including those that the ACMG itself has hosted. It is important that these ongoing updates of the recommendations continue and that the discussions have input from all stakeholders including, but not limited to, patient advocacy groups, regulatory agencies, geneticists and genetic counselors, oncologists, hematologists, pediatricians and pediatric subspecialists, bioethicists, sequencing experts, and industry partners.

The recent revisions to the ACMG’s recommendations place greater weight on the diversity of patient interests and the importance of individual autonomy. As many have acknowledged, we need to develop new ways to assist patients in making informed choices that best fit their individual needs and better understand how individual patients perceive actionability. We believe an individualized, patient-centered approach to WES/WGS is necessary and attainable to realize the full potential of sequencing techniques to improve medical care.

 

Read more at the Star Tribune.

Article featured on Mayo Clinic Proceedings.

 

 

Jun 24, 2014 · Effective Methods for Combating Aggressive Forms of Lung Cancer Publication

 

Lung Adenocarcinoma

According to a recently published article in the journal Cancer Research, a new study from the Center for Individualized Medicine has found tumor sequencing of several different lung cancers and their surrounding tissue complicates the prevailing theory of linear lung cancer progression and offers new insights for management of this deadly cancer. Sequencing results provide, for the first time, strong molecular evidence of progression from phenotypically indolent components to more aggressive disease and also show that both components can progress independently, even if they arise from the same precursor, according to the study.

“This study sheds light on potential changes in our understanding of both the molecular pathogenesis and best treatment of lung adenocarcinoma,” says George Vasmatzis, Ph.D., co-director of the Biomarker Discovery Program. “The heterogeneity of lung cancer tells us repeatedly that the natural history of tumors and the roads to progression vary among cases, and multiple models are possible in certain cancers.”

Future studies of lung cancer genomics and tumor progression are underway from Vasmatzis’ team in the Biomarker Discovery Program. Their goal is to develop a series of predictive biomarkers that can help patients and physicians separate potentially aggressive and life-threatening lung cancers from indolent ones based on the molecular signatures found within the individual patient’s tissue.

 

Full Article Featured on Advanced Healthcare Network.

 

 

 

Jun 19, 2014 · New Collaboration With Enterome to Develop and Commercialize Microbiome-based Diagnostic Tools

Gut Feeling

Full Press Release featured on Enterome Bioscience.

Enterome Bioscience and the Center for Individualized Medicine at Mayo Clinic have entered into an agreement to begin collaboration focused on the discovery and validation of gut microbiome based diagnostic tests for predicting responses to medical nutritional intervention in overweight or obese patients.

“It is well known that a healthy diet and regular exercise are key to losing weight, but there is another factor that may be just as influential – a person’s microbiome,” said Vandana Nehra, M.D., Division of Gastroenterology and Hepatology, Mayo Clinic. “This study will use a weight loss program at Mayo Clinic to examine the effect of intervention with diet and exercise on the microbiome.”

A panel of bacterial biomarkers from the gut microbiome, known collectively as MET 230, were identified by Enterome’s scientific founder Dusko Ehrlich and collaborators at the French National Institute for Agricultural Research (INRA) and the Institute of Cardiometabolism and Nutrition (ICAN). These biomarkers enable the stratification of patients based on the health and diversity of their personal gut microbiome, and with a recent 400-patient study, they have been correlated to the metabolic profile of obese patients as well as to their responsiveness to nutritional intervention.

“The signing of this agreement with Mayo Clinic is another key corporate milestone for Enterome, and I am very pleased Mayo Clinic will work with us on such an important project. It is clear that new personalized medicine/nutrition solutions are needed if we are going to properly address the growing problem of obesity and its negative impact on public health,” said Pierre Belichard, CEO of Enterome.

Mayo Clinic is conducting a study currently to characterize the gut microbiome before and after dietary intervention. This study, if successful, would enable the commercialization of a personalized nutrition test for patients with obesity associated with low grade inflammation and certain metabolic risk factors.

One-third of the US population is currently obese, and this proportion is expected to increase to 50% by 2030. Nearly $200 billion annually is spent on obesity-related illnesses in the US; while approximately 40% of the US population is dieting at any point in time, resulting in a market for weight management products worth $20 billion per year.

From this scientific finding, Enterome, under a license agreement with INRA, is developing a diagnostic test dedicated to the management of obesity and personalization of medical nutrition to patient’s needs. It is hoped that the application of Enterome’s technology will be a key driver for improving the outcome of stratified nutritional strategies and in the future the development of novel drugs or functional food products aiming to decrease comorbidities associated to overweight and obesity (i.e. type 2 diabetes).

 

 

 

 

Jun 17, 2014 · Biomarkers 101 Part 1


George Vasmatzis, Ph.D., and John Cheville, M.D., co-directors of the Biomarker Program at the Center for Individualized Medicine at Mayo Clinic, introduce us to the world and work of Biomarkers.

Biomarkers are molecular substances in the body that can be used to indicate health or disease. These biomarkers can be found in tissue, blood, urine and other body fluids. Prostate and ovarian cancers are two examples of how the use of biomarkers can lead to individualized diagnosis and treatment.

The Biomarker Discovery Program is a multidisciplinary team that includes oncologists, surgeons, pathologists, molecular biologists, bioengineers, bioinformaticians and others. By combining expertise, the program takes a clinical question, and answers it through a four-phase approach: Discovery, experimental validation, preclinical validation and clinical validation.

 

Discover the latest in Biomarkers, and Genomics, at our annual Individualizing Medicine Conference this year, October 6-8!
 
 
 

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