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U-M Health System Launches $160M Project to Improve Lab Tests for Patients in Michigan and Beyond

Millions of times a year, teams at the University of Michigan Health System test samples of tissue, blood and other bodily fluids for patients of all ages. The results can reveal risks or signs of disease — or response to treatment — and help make a major difference in doctors’ decisions.

Definiens Signs Agreement with Clarient to Offer Validated Solutions for Routine Clinical Pathology Testing

Definiens, the global leader in image analysis for digital pathology and diagnostics recently announced the signing of an agreement with Clarient Diagnostic Services, Inc.- which extends the use of Definiens’ automated image analysis software and solutions in Clarient’s validated clinical applications for immunohistochemistry testing in breast cancer. Definiens’ proprietary Cognition Network Technology® is core to automatically classify and quantitate key tissue features as part of Clarient’s Scope IA Platform offering to its pathology customers.

Promising Screening Tool for Early Detection of Ovarian Cancer

Evaluating its change over time, CA-125, the protein long-recognized for predicting ovarian cancer recurrence, now shows promise as a screening tool for early-stage disease, according to researchers at The University of Texas MD Anderson Cancer Center.

The updated findings are published in Cancer; preliminary data were first presented at the 2010 American Society of Clinical Oncology (ASCO) annual meeting. If a larger study shows survival benefit, the simple blood test could offer a much-needed screening tool to detect ovarian cancer in its early stages – even in the most aggressive forms – in post-menopausal women at average risk for the disease.

MD Anderson has a long history in the research of the important biomarker. In the 1980s, Robert Bast, M.D., vice president for translational research at MD Anderson and co-investigator on the ASCO study, discovered CA-125 and its predictive value of ovarian cancer recurrence. Since then, researchers at MD Anderson and beyond have been trying to determine its role in early disease detection. The marker, however, can become elevated for reasons other than ovarian cancer, leading to false positives in early screening.

“Over the last ten years, there’s been a lot of excitement over new markers and technologies in ovarian cancer,” said Karen Lu, M.D., professor and chair, Department of Gynecologic Oncology and the study’s corresponding author. “I and other scientists in the gynecologic oncology community thought we would ultimately find a better marker than CA-125 for the early detection of the disease. After looking at new markers and testing them head-to-head in strong, scientific studies, we found no marker better than CA-125.”

According to the American Cancer Society, 22,240 women will be diagnosed with ovarian cancer in 2013 and another 14,030 are expected to die from the disease. The challenge, explained Lu, is that more than 70 percent of women with ovarian cancer are diagnosed with advanced disease.

“Finding a screening mechanism would be the Holy Grail in the fight against ovarian cancer, because when caught early it is not just treatable, but curable,” said Lu, also the trial’s principal investigator.

For the prospective, single-arm, 11-year study, 4,051 women were enrolled from seven sites across the country, with MD Anderson serving as the lead site. All were healthy, post-menopausal women, ages 50-74, with no strong family history of breast or ovarian cancer. The study’s primary endpoint was specificity, or few false positives. In addition, the study looked at the positive predictive value, or the number of operations required to detect a case of ovarian cancer.

Each woman received a baseline CA-125 blood-test. Using the Risk of Ovarian Cancer Algorithm (ROCA), a mathematical model based on the patient’s age and CA-125 score, women were stratified to one of three risks groups, with the respective follow-up: “low,” came back in a year for a follow-up blood test; “intermediate,” further monitoring with repeat CA-125 blood test in three months; and “high,” referred to receive transvaginal sonography (TVS) and to see a gynecologic oncologist.

Based on the women’s CA-125 change over time, the average annual rate of referral to the intermediate and high groups were 5.8 percent and .9 percent, respectively. Cumulatively, 117 women (2.9 percent) were determined to be high risk, and thereby received the TVS and were referred to a gynecologic oncologist. Of those women, 10 underwent surgery: four had invasive ovarian cancer; two had borderline disease; one had endometrial cancer and three had benign ovarian tumors – a positive predictive value of 40 percent, which greatly surpasses the clinical benchmark of 10 percent, say the researchers. The specificity of the test was 99.9 percent, explained Lu. The screening failed to detect two borderline ovarian cancers.

Of great importance, said Lu, is that the four invasive ovarian cancers detected were high-grade epithelial tumors, the most aggressive form of the disease, and were caught early (stage IC or IIB), when the disease is not only treatable, but most often curable. Lu also noted that all four women found to have invasive disease were monitored at low risk for three years or more prior to a rising CA-125.

“CA-125 is shed by only 80 percent of ovarian cancers,” explained Bast, the study’s senior author. “At present, we are planning a second trial that will evaluate a panel with four blood tests including CA-125 to detect the cancers we may otherwise miss with CA-125 alone. The current strategy is not perfect, but it appears to be a promising first step.”

While encouraging, the findings are neither definitive, nor immediately practice-changing, stressed Lu; who also said a large, randomized prospective screening trial still needs to be conducted. Such research is ongoing in the United Kingdom; results from more than 200,000 women should be known by 2015.

“As a clinician treating women with this disease for more than ten years, I’ve become an admitted skeptic of ovarian cancer screening. Now, with these findings, I’m cautiously optimistic that in the not too distant future, we may be able to offer a screening method that can detect the disease in its earliest, curable stages and make a difference in the lives of women with this now-devastating disease.”

The study is continuing; and, as follow-up, Lu and her team plan to look at combining other markers with CA-125 to determine the screening impact of their combined change over time.

The study was supported by the National Cancer Institute, and was a research project of MD Anderson’s ovarian cancer Specialized Program of Research Excellence (SPORE), NCI P50 CA83639, the Bioinformatics Shared Resources of MD Anderson CCSG NCI P30 CA16672, the National Foundation for Cancer Research. It has also received philanthropic funds from Golfers Against Cancer, the Tracy Jo Wilson Ovarian Cancer Foundation, the Mossy Foundation, the Norton family and Stuart and Gaye Lynn Zarrow.

In addition to Lu, and Bast, other authors on the study include: Therese Bevers, M.D. Department of Clinical Cancer Prevention, Herbert Fritsche, Ph.D., Department of Laboratory Medicine, Deepak Bedi, M.D., Department of Diagnostic Radiology, Michael T. Deavers, M.D., Department of Pathology and Clinical Pathology; Charlotte Sun, Dr.PH, Department of Gynecologic Oncology, Mary A. Hernandez, Office of Translational Research, all with MD Anderson; Steven Skates, Ph.D., Massachusetts General Hospital and Harvard Medical School; Olasunkanmi Adeyinka, M.D., UT Physicians Family Physicians; William Newland, M.D., The Iowa Clinic; Richard Moore, M.D. and Cornelius Granai, M.D., both with Women & Infants Hospital, Brown University; Leroy Leeds, M.D., OGA Medical Center; Steven Harris, M.D., OB/GYN Associates of Dallas; Jeremy Geffen, M.D., Geffen Cancer Research Institute; and Nora Horick, Harvard Medical School and Massachusetts General Hospital.

As a co-inventor of the CA-125, Bast receives royalties from, and has served as an advisor to, Fujirebio Diagnostics, Inc.

Study: A 2-stage ovarian cancer screening strategy using the Risk of Ovarian Cancer Algorithm (ROCA) identifies early-stage incident cancers and demonstrates high positive predictive value [Cancer]

Source: MD Anderson Cancer Center

Definiens Establishes Advisory Board

Definiens, the global leader of image and data analysis solutions for quantitative digital pathology, recently announced it has appointed an Advisory Board comprising renowned industry experts and visionaries in digital pathology. As part of its market expansion strategy, Definiens established the new Board to provide independent advice on trends and opportunities in tissue diagnostics and clinical digital pathology.

Members of the Advisory Board include:

  • Ron A. Andrews, President, Medical Sciences, Life Technologies and former CEO of Clarient and CEO of GE Molecular Diagnostics
  • Prof. Uwe Bicker, Dean of the Medical Faculty Mannheim, University of Heidelberg and a member of the board of directors of Sanofi SA
  • Prof. Manfred Dietel, Director, Institute of Pathology, Charité Berlin and chairman of the German Society for Pathology
  • Eric F. Glassy, M.D., Medical Director, Pathology, Inc.and chairman of the Digital Pathology Working Group of the College of American Pathologists
  • Prof. Gerd Binnig, Founder and CTO, Definiens (Moderator)

“Definiens is working to advance personalized medicine by contributing to the development of next generation diagnostics, and bringing those novel diagnostics into clinical practice. Our innovations have the potential to transform daily clinical practice for the benefit of both patients and pathologists, particularly in oncology,” said Thomas Heydler, CEO of Definiens. “We will greatly benefit from the wealth of experience of the Advisory Board members while expanding our business into tissue diagnostics and clinical digital pathology.”

As part of its goal to guide Definiens during the company’s expansion, the Advisory Board will discuss trends in digital pathology and highlight opportunities for image and data analysis to revolutionize clinical practice in pathology. Specific topics of discussion will include pathology workflow, tissue diagnostic test development, personalized medicine and next-generation cancer treatment, as well as future technology and market requirements. Definiens founder and Nobel laureate, Professor Gerd Binnig, will catalyze the discussions.

“With the novel opportunities enabled by digital pathology, progress in diagnosing and treating cancer will be accelerated. The visionary power and expertise brought together in the Definiens Advisory Board will be invaluable on our path towards bringing advanced image analysis to clinical pathology,” said Prof. Gerd Binnig, Founder and CTO of Definiens.

Source: Definiens

First Test to Objectively Diagnose Fibromyalgia Now Available

A recent peer-reviewed study, published in BMC Clinical Pathology,[1] reveals a medical breakthrough discovering multiple biomarkers based upon highly sensitive and reproducible medical investigations. Conducted by the University of Illinois College of Medicine at Chicago (UIC) and EpicGenetics, a privately-held biomedical company, the research has led to the development of The FM/a® Test (www.thefmtest.com), the first test to objectively diagnose fibromyalgia.

Researchers at the UIC Department of Pathology conducted a statistically significant study involving more than 200 patients, comparing those clinically diagnosed with fibromyalgia to healthy patients. The study revealed that patients with fibromyalgia have a dysregulation disorder affecting protein molecules called chemokines and cytokines, produced by white blood cells. While fibromyalgia patients have been classified to be hyperactive (or overactive) responders, the study showed that people with fibromyalgia have immune production patterns which may make them more vulnerable to stress, thereby leading to chronic pain, severe fatigue, diffuse muscle tenderness, insomnia, and other unbearable symptoms long associated with fibromyalgia. Evaluation of The FM Test patient results will provide a continuing database that could lead to further insight into what may cause and exacerbate fibromyalgia and permit the development of standards to determine effective treatments.

EpicGenetics worked with fibromyalgia support groups to recruit participants in the clinical research study and is collaborating with groups such as the National Fibromyalgia & Chronic Pain Association to educate the fibromyalgia community and others about the availability of The FM Test.

“The results of our research have allowed us to ‘pull back the curtain’ and identify specific diagnostic biomarkers in fibromyalgia,” said Bruce S. Gillis, MD, MPH, member of the clinical faculty at the UIC College of Medicine and founder of EpicGenetics. “For decades, the medical community has viewed fibromyalgia with much skepticism. Patients have been stigmatized, and many are spending thousands of dollars and years of frustration in search of a diagnosis. Our breakthrough provides patients with hope and validation that their symptoms are real, and we hope physicians who commonly see patients with fibromyalgia will embrace and value this test for its role in the advancement of medical care.”

According to the American College of Rheumatology, fibromyalgia affects more than 12.3 million people in the United States, comparable to the number of people affected by cancer. Patients who experience symptoms, such as chronic pain and fatigue, depression and insomnia, spend an average of three to five painful years seeking a diagnosis and $4,800-$9,300 annually on associated medical costs. Until now, there has been no conclusive test to confirm the diagnosis of fibromyalgia.

The FM Test, a simple blood test with more than 93 percent sensitivity, now makes it possible for anyone to find out if they have fibromyalgia. The FM Test costs $744 with conclusive results available to most patients usually in a week or less – a fraction of the time and money the average patient currently spends seeking a diagnosis.

By completing a simple symptoms questionnaire at www.thefmtest.com, patients and their doctors can find out if they qualify for the test. If a patient meets the requirements, they can arrange for the test at their doctor’s office or at an independent blood draw facility.

“The elegantly designed study by Dr. Gillis and his co-investigators represents a milestone on the path our group charted 25 years ago when we first hypothesized that cytokines play a role in fibromyalgia2. It is hoped that this and future work sponsored by EpicGenetics will lead to a greater understanding of how the immune system, fatigue, sleep disorders, chronic stress and pain interact in patients with fibromyalgia and related disorders,” said Daniel J. Wallace MD, FACP, FACR, a clinical professor of medicine at the David Geffen School of Medicine at UCLA based at Cedars-Sinai Medical Center, and a member of the Scientific Advisory Board of EpicGenetics.

Source: Business Wire