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Researchers Develop Specific Tests to Identify Cancer Biomarkers in Dermatomyositis

Researchers from major universities in the U.S. have developed specific tests to identify cancer biomarkers in patients with dermatomyositis—a systemic inflammatory disease associated with increased risk of malignancy. According to study findings published in the American College of Rheumatology (ACR) journal, Arthritis & Rheumatism, the assays detect antibodies against anti-transcriptional intermediary factor-1 (TIF-1γ) and nuclear matrix protein NXP-2.

Patients with dermatomyositis experience muscle weakness, skin inflammation, and sometimes inflammation of the lung. Most patients with dermatomyositis have auto-antibodies circulating in their bodies that cause distinct clinical disease features. Medical evidence suggests that these auto-antibodies in dermatomyositis patients stem from specific immune responses that shape various characteristics (phenotypes). In addition, up to 20% of those with dermatomyositis are at increased risk of malignancies.

“For the physician treating patients with dermatomyositis, identifying those at higher risk for cancer is a top priority,” explains Dr. David Fiorentino from Stanford University in Redwood City, Cal. “Our team focused on creating specific tests to detect antibodies against two specific proteins and then testing if those antibodies can identify dermatomyositis patients at higher risk of cancer.”

The team used both immunoblotting and immunoprecipitation techniques to detect antibodies against TIF-1γ and NXP-2 proteins. Blood analysis was performed on 111 patients from Stanford University Dermatology Clinic and 102 patients from the Johns Hopkins University (JHU) Myositis Center. Both groups were similar in gender and age at diagnosis.

Results show that 17% and 38% of subjects in the two cohorts combined had antibodies against NXP-2 and TIF-1γ, respectively. Using the specific assays, researchers found 83% of dermatomyositis patients with cancer had a reaction to NXP-2 or TIF-1γ. Further analysis indicates that cancer, older age, and male gender were linked to NXP-2 or TIF-1γ antibodies, with anti-NXP-2 specifically associated with cancer in men.

“Our findings confirm the link between cancer and age in dermatomyositis, with a sharp increase in frequency at roughly 60 years of age.” concludes Dr. Fiorentino. “By determining the presence or absence of NXP-2 and TIF-1γ antibodies, we believe that this will aid clinicians in identifying those with the highest cancer risk.”

Study: Most patients with cancer-associated dermatomyositis have antibodies to nuclear matrix protein NXP-2 or transcription intermediary factor 1-gamma [Arthritis & Rheumatism]

Source: EurekAlert!

JAMA Pediatrics Study Highlights Cancer Risk Associated with CT Scans

Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked APPY1 Test, a rapid, protein biomarker-based assay for identifying patients at low risk for appendicitis, today announced its support of key findings from a large retrospective study that was published earlier this week in the peer-reviewed medical journal JAMA Pediatrics. The study concluded, among other things, that the risk of radiation-induced solid cancers was highest for patients undergoing CT scans of the abdomen/pelvis and that abdominal/pelvic scans saw the most dramatic increase in use over the study period, especially among older children. Possible appendicitis was cited as a leading cause of abdominal/pelvic CT usage.

Importantly, the authors of the study concluded that reducing unnecessary CT scans in favor of other imaging or non-imaging approaches (if proven through research to be as effective), combined with effective radiation dose-reduction strategies, could dramatically reduce the number of radiation-induced cancers.

Steve Lundy, President and CEO of Venaxis, stated, “The findings of this large observational study are aligned with our focus – developing a blood-based APPY1 Test to aid physicians in identifying patients at low risk for acute appendicitis. We applaud the authors of the study for reporting these findings and for highlighting the urgent need for research to determine when the use of CT scans leads to improved health outcomes and when other imaging and non-imaging diagnostic techniques could be as effective. The APPY1 Test is designed to provide rapid, objective results and has demonstrated high negative predictive value for appendicitis in clinical studies. Venaxis’ goal with the APPY1 Test is to provide physicians with an additional tool that may allow for more conservative patient management, including reducing the number of CT scans.”

The JAMA Pediatrics study measured the rate of CT scan use (from 1996 to 2010) and the dose of ionizing radiation (for CT scans performed between 2001 and 2011) in children younger than 15 years of age, and estimated the lifetime attributable risks of certain cancers. The projected lifetime attributable risk of developing solid cancers was higher for patients who underwent CT scans of the abdomen/pelvis or spine than for patients who underwent other types of CT scans. The risk was highest for younger patients and for girls, with a radiation-induced solid cancer projected to result from every 300 to 390 abdomen/pelvis scans.

Study: The Use of Computed Tomography in Pediatrics and the Associated Radiation Exposure and Estimated Cancer Risk

Source: Venaxis

Cancer Biomarker Study Data Presented at the 2013 AACR Meeting

As we’ve done in previous years here at Biomarker Commons (AACR 2011 and AACR 2012), here’s a roundup of eight research studies on cancer biomarkers that were presented last month at the American Association for Cancer Research (AACR) Annual Meeting in Washington, DC. The theme of this year’s meeting was “Personalizing Cancer Care Through Discovery Science.”

  • Biomarker Analysis Identified Women Most Likely to Benefit From T-DM1

    According to data from a subanalysis of a phase III clinical trial that led the U.S. Food and Drug Administration to approve trastuzumab emtansine (T-DM1) in February, the amount of HER2 in tumors of women with metastatic, HER2-positive breast cancer might determine how much they benefit from the drug. The findings were presented by José Baselga, M.D., Ph.D., physician-in-chief at Memorial Sloan-Kettering Cancer Center in New York.

    Source: AACR

  • Novel Serum Biomarker Bilirubin Predicted Lung Cancer Risk in Smokers

    Researchers from MD Anderson Cancer Center in Houston, Texas, used a unique multiphase study design for the metabolomics profiling of serum samples from non-small lung cancer patients, and showed that bilirubin is a potential biomarker for lung cancer risk prediction. Men who were smokers and had low bilirubin levels had increased risk for cancer incidence and mortality.

    Source: AACR

  • Biomarkers Discovered That May Help Predict Response to Drugs Targeting KRAS-mutated NSCLC

    Massachusetts General Hospital scientists have identified biomarkers that may help predict whether patients with KRAS-mutated non-small cell lung cancer (NSCLC) will respond to concurrent treatment with an MEK inhibitor and a PI3 kinase inhibitor, a drug combination currently being investigated in ongoing clinical trials.

    Source: AACR

  • Screening Blood Samples for Cancer-driving Mutations More Comprehensive Than Analyzing Traditional Tumor Biopsy

    Using a tool called BEAMing technology, which can detect cancer-driving gene mutations in patients’ blood samples, researchers from Dana-Farber Cancer Institute and Harvard Medical School showed that were able to identify oncogenic mutations associated with distinct responses to therapies used to treat patients with gastrointestinal stromal tumors (GIST).

    Source: AACR

  • More Accurate Markers Identified for Detecting Response to Epigenetic Drugs for Myelodysplastic Syndromes

    Researchers from the University of Southern California, Los Angeles, have identified and validated two DNA methylation markers that could help physicians better determine a patient’s response to DNA methyltransferase inhibitors (DNMTi) for the treatment of myelodysplastic syndromes (MDS).

    Source: AACR

  • Cohort Study Indicates That Selenium May Be Protective Against Advanced Prostate Cancer

    According to a data presented by researchers from Maastricht University in the Netherlands, a greater level of toenail selenium is associated with a significant decrease in the risk for advanced prostate cancer.

    Source: AACR

  • Comprehensive Genomic Analysis Identified Alterations in Head and Neck Cancer That Could Lead to Targeted Therapy

    A National Institutes of Health project to catalog the genetic alterations responsible for several types of cancer, in particular those with a poor prognosis, finds that head and neck squamous cell carcinomas are genomically heterogeneous. However, those cancer with certain distinctive patterns could be amenable to specific targeted therapies.

    Source: AACR

  • Novel Drug Combination Showed Antitumor Activity in Patients With Incurable BRCA-deficient Cancers

    Researchers from Dana-Farber Cancer Institute and Harvard Medical School have identified two orally available experimental drugs — sapacitabine and seliciclib — from phase I trial data that, when given sequentially, work together to elicit antitumor effects in patients with incurable BRCA-deficient cancers.

    Source: AACR

Low Levels of Serum Bilirubin Spell Higher Lung Cancer Risk for Male Smokers

Elevated levels of bilirubin in the blood get attention in the clinic because they often indicate that something has gone wrong with the liver. Now researchers have found that male smokers with low levels of the yellow-tinged chemical are at higher risk for lung cancer and dying from the disease.

A team led by researchers at The University of Texas MD Anderson Cancer Center reported its findings in a late-breaking abstract at the AACR Annual Meeting 2013 in Washington, D.C.

“Our study indicates male smokers with low levels of bilirubin are a high-risk group that can be targeted with smoking cessation help, low-dose spiral CT screening of their lungs and other preventive measures,” said senior author Xifeng Wu, M.D., Ph.D., professor and chair of MD Anderson’s Department of Epidemiology and the Betty B. Marcus Chair in Cancer Prevention.

Lung cancer usually is diagnosed at a late stage, when tumors are inoperable and treatments largely ineffective. The overall five-year survival rate is 15 percent, but it falls to 5 percent for stage 3 lung cancer patients and 1 percent for those with stage 4 disease.

Spiral CT scans catch cancer early, biomarker could reduce false positives

The National Lung Screening Trial found that low-dose spiral computed tomography screening reduces mortality among heavy smokers by 20 percent. However, 95 percent of growths found by spiral CT are false positives, a barrier to large-scale screening.

“Validated biomarkers are urgently needed to improve risk prediction for lung cancer and to reduce false positives, shifting the balance toward more effective and efficient CT screening for cancer detection,” Wu said.

The researchers started with an objective analysis of levels of metabolites — substances produced during metabolism. Bilirubin is produced during the breakdown of old blood cells.

They analyzed 60 samples divided into three groups known as “trios” — normal controls, early stage and late stage non-small cell lung cancer patients. The top three metabolites were validated in two more groups of 50 and 123 trios.

When bilirubin emerged as the most significant metabolite, another validation study was done in a prospective cohort of 435,985 people with 208,233 men in Taiwan.

Men were divided into four groups according to their serum bilirubin levels. Lower bilirubin level was associated with significantly higher rates of both lung cancer incidence and mortality.

In the Taiwanese cohort, the incidence rate per 10,000 person-years in men was 7.02 for those in the lowest bilirubin quartile (.68 mg/dL or less), compared to 3.73 in the highest quartile of bilirubin level (1.12 mg/dL or more). The mortality rate per 10,000 person-years was 4.84 for the lowest level compared with 2.46 in the highest bilirubin quartile.

Next step: Establish a risk prediction model in heavy smokers

Bilirubin makes sense as a protective agent because of its anti-oxidant, anti-inflammatory and anti-proliferative effects. “It’s plausible that bilirubin protects against lung cancer by scavenging free radicals and carcinogens associated with smoking,” said study presenter Fanmao Zhang, a doctoral candidate in epidemiology.

Indeed, a Belgian study showed that bilirubin in the high normal range lowered cancer mortality in men. A study in the United Kingdom showed higher bilirubin levels in the normal range were associated with lower risks of chronic obstructive pulmonary disease, lung cancer and all-cause mortality. Neither of those studies stratified their analysis of bilirubin by smoking status.

“We expected that bilirubin might be protective, but our finding that bilirubin levels affect only smokers was somewhat of a surprise,” Wu said. “Our discovery that low levels increase lung cancer risk is unique.”

Smokers in the two middle cohorts of bilirubin levels also had higher lung cancer risk than those in the highest quartile. As an objective risk index for lung cancer and all-cause mortality, low levels of bilirubin should send an urgent message to quit smoking, said Chi Pang Wen, M.D., Ph.D., co-lead author from National Health Research Institutes, Taiwan.

The next step, Wu said, is to evaluate the predictive value of serum bilirubin in heavy smokers and to establish a risk prediction model that incorporates bilirubin and other biomarkers with clinical and epidemiological data to improve the efficiency of lung cancer risk prediction.

Source: EurekAlert!

HALO Healthcare Finalizes License Agreement With University of North Dakota for Cancer Detection Biomarkers

HALO Healthcare, Inc., a provider of innovative diagnostic solutions for women’s breast care announced that it has signed a definitive license agreement with the University of North Dakota (UND) to develop biomarkers for the early detection of breast cancer. Early detection of breast cancer has significant health and economic benefits. The licensed UND technology is based on detecting cancer biomarkers in breast nipple aspirate fluid (NAF) which is the platform used for the HALO® Breast Test marketed by Halo Healthcare for breast cancer risk assessment. Over 25,000 HALO tests have been performed worldwide.

France Dixon Helfer, President and CEO of Halo Healthcare states, “This license has the opportunity of providing women all over the world an annual early breast detection test years before it is visible by mammography or other imaging technologies used for breast cancer screening. Our scientists are developing a laboratory ‘test kit’ which could revolutionize the breast cancer care path. This empowering breakthrough technology will enable physicians to find and treat breast cancer at a very early stage so all women can be spared the devastating effects of later staged breast cancer.”

Dr. Edward Sauter, the inventor of the biomarker technology and a practicing breast surgeon, acknowledges the potential clinical value by noting “this biomolecular technology strikes at the root cause of cancer and its development is the result of many years of research effort.” Dr. Sauter further states that “with appropriate clinical validation the test will be of great value to breast cancer specialists and to women.”

“The University of North Dakota is happy to have executed this definitive exclusive license agreement with HALO Healthcare, Inc.,” said Michael F. Moore, the university’s associate vice president, intellectual property commercialization & economic development. “We believe HALO Healthcare is a dedicated partner, committed to developing this technology to improve breast cancer diagnostic technology. UND looks forward to a long relationship with HALO Healthcare.”

Source: HALO Healthcare