Value Propositions

May 2014, Vol 5, No 4 - Value Propositions

Novel 10-Gene Blood Assay a Biomarker for Predicting Breast Cancer Recurrence

Noninvasive, multigene tests are increasingly being developed for a variety of cancers to potentially replace more invasive and often more costly types of testing. The new 10-gene–based assay, called cMethDNA, is highly sensitive and specific for detecting breast cancer recurrence early (Fackler MJ, et al. Cancer Res. 2014;74:2160-2170). The cMethDNA blood-based assay includes a panel of 10 breast cancer–specific genes.

“Currently, the parameters used to find out whether a patient has had a recurrence after being treated successfully is mostly self-reported complaints, followed by imaging studies,” said Saraswati Sukumar, PhD, Professor of Oncology and Pathology, Johns Hopkins University School of Medicine, Baltimore. “Our goal was to develop a noninvasive assay that can potentially detect recurrence in breast cancer patients before traditional methods, and administer this test during their scheduled visits.”

The 10 genes in the panel include 7 novel markers, AKR1B1, COL6A2, GPX7, HIST1H3C, HOXB4, RASGRF2, and TM6SF1, and 3 previously described markers, ARHGEF7, TMEFF2, and RASSF1.”

“Using cMethDNA, we were able to detect a drop in methylation levels as early as two weeks, and weeks before traditional imaging methods can detect a recurrence,” said Dr Sukumar. “Detecting early on whether or not the treatment is working for a patient can greatly help prevent unnecessary exposure to highly toxic agents, save time, and help initiate other treatments more likely to be beneficial.”

The authors selected the panel of 10 genes that best differentiated between cancer and normal samples to confirm that the blood test detected the presence of cancer DNA in the serum with a sensitivity and specificity of >90%. Using blood samples from patients with metastatic breast cancer, the cMethDNA assay showed a significant decrease in serum DNA methylation levels in patients who responded to the treatment versus no reduction in patients who had no response to therapy or in patients with disease progression. American Association for Cancer Research press release; April 15, 2014

Skin Cancer Awareness Month in May Prompts Donations to Melanoma Research Foundation

May, the skin cancer awareness month, served as the impetus for MoleSafe USA—a program that provides melanoma screening and surveillance via total body photography, digital dermoscopy, and digital serial monitoring—to partner with the Melanoma Research Foundation to support the foundation’s efforts in raising awareness of melanoma, promoting education, and encouraging early detection through melanoma screening programs and monthly self-skin examinations.

MoleSafe, with locations in the United States, Australia, and New Zealand, is donating $10 to the Melanoma Research Foundation for every screening it conducts in the month of May to promote skin health and to encourage research and screening related to melanoma, where early detection can have a significant impact on clinical outcomes. Despite the significant reductions in the number of new cases of cancer, melanoma remains the cancer with the fastest growing incidence rate. In 2014, approximately 76,000 Americans are expected to be diagnosed with melanoma, leading to approximately 10,000 deaths, according to the American Cancer Society.

“The Melanoma Research Foundation is leading the melanoma community to transform melanoma from one of the deadliest cancers to one of the most treatable through research, education and advocacy,” said Richard Bezozo, MD, President of MoleSafe. “While there currently isn’t a cure for melanoma…when caught early, the five-year survival rate can near 99 percent.” Being aware of the warning signs of melanoma, including the appearance of a new bump or nodule, color spreading into the surrounding skin, redness or swelling beyond the mole, pain, tenderness, skin itching, and/or bleeding can expedite detection and improve outcomes. Monitoring for changes in skin moles and lesions is important. MoleSafe, Inc press release; May 1, 2014

Drug Maker Releasing Detailed Clinical Trials Data to the Medical Community

Much criticism has been aimed at drug companies in recent years related to the common practice of withholding unfavorable or undesirable data from clinical trials to protect their newly developed products. Responding to this trend and in an effort to promote progress in medical research, Boehringer Ingelheim has announced that it is engaged in a program to make clinical study data and other clinical study–related documents more widely accessible for drugs and other therapies approved by regulatory agencies after the approval of or termination of a drug development program.

“The free exchange of scientific information is the basis for innovation in medicine. Boehringer Ingelheim as a research-driven pharmaceutical company is committed to the registration of all clinical studies prior to initiation and to disclosing all study results independent of outcome. Going beyond applicable regulatory and legal requirements, we at Boehringer Ingelheim feel it is the right approach and hope it will benefit science,” said Dr Christopher Corsico, Global Head of Clinical Development, Medicine and Regulatory at Boehringer Ingelheim.

Boehringer Ingelheim will register protocol information for all types of clinical studies on, including phase 1 clinical trials in healthy volunteers, and uncontrolled and noninterventional studies for all prescription and nonprescription drugs performed worldwide. The company is committed to providing information related to studies started in 1998 or later. Starting with studies completing in 2014, the company will also post study results on for products approved outside of the United States only and from terminated drug development programs.

Furthermore, clinical study reports and other clinical documents can be requested via the company’s website, accessible under This website will also enable researchers to request access to deidentified patient level study data that form the basis of clinical trial findings. The company made these commitments in 2013, but they are now being implemented. Boehringer Ingelheim press release; May 12, 2014

Low-Value Services, Including in Oncology, Cost Medicare Billions of Dollars

A new study investigating the efficiency of care under Medicare using 2009 data shows that much of the care provided to Medicare beneficiaries is not cost-effective and cost Medicare $8.5 billion that year in inefficient services (Schwartz AL, et al. JAMA Intern Med; 2014 May 12. Epub ahead of print). This translates to $310 per beneficiary on services determined in this study to be low-value care.

The study is based on insurance claims for >1.3 million Medicare beneficiaries, showing that between 25% and 42% of beneficiaries received low-value services that provided little or no benefit to patients.

The investigators reviewed 26 procedures that were deemed to be of low value based on the Choosing Wisely program; these included cervical cancer screening for women aged ?65 years, computed tomography scanning of the sinuses for uncomplicated acute rhinosinusitis, preoperative stress testing, and back imaging for patients with lower back pain. The total cost for these services amounted to $8.5 billion.

“There are hundreds of other low-value services,” said coinvestigator J. Michael McWilliams, MD, PhD, Associate Professor of Health Care Policy, Harvard Medical School. “We suspect this is just the tip of the iceberg.”

“We were surprised that these wasteful services were so prevalent,” said lead author Aaron Schwartz, MD, PhD, student of Health Care Policy, Harvard Medical School. “Even just looking at a fraction of wasteful services and using our narrowest definitions of waste, we found that one-quarter of Medicare beneficiaries undergo procedures or tests that don’t tend to help them get better.”

The researchers suggest that using claims-based measures of low-value services could help to develop programs to reduce unnecessary, wasteful care, as well as to identify specific cases of overuse of care among the most efficient providers. Kaiser Health News; May 12, 2014