Quantcast

Industry news that matters to you.  Learn more

CellMax Life Takes Liquid Biopsy to Next Level with 73 Gene Profile ctDNA Blood Test

CellMax Life, the precision cancer testing company, recently announced the commercial availability of CellMax-LBx Liquid Biopsy in India. CellMax-LBx is a cancer blood test which analyzes circulating tumor DNA (ctDNA). The assay provides oncologists with a valuable tool in managing their patients’ cancer treatments, monitoring treatment response, and assessing the risk of recurrence.

Deadly Effects of Certain Kinds of Household Air Pollution Lead to Call for Biomarker Studies

Almost four million people die each year from household air pollution (HAP) caused by exposure to the combustion of biomass fuels (wood, charcoal, crop residues, and dung), kerosene, or coal. These individuals are among the tens of millions who rely on such products to cook their meals, heat their rooms, and light their homes. Those in lower and middle income countries are among the hardest hit by the effects of HAP exposure, which also causes childhood respiratory infection, chronic lung disease, and cardiovascular disease. Exposure to biomass fuel is associated with low birth weight, asthma, and tuberculosis.

Given these effects, the large populations at risk, and a growing global interest in lower-cost energy sources, researchers from three continents have published a comprehensive overview of the current approaches to HAP assessments, the aims of biomarker development, and the state of development of tests which have the potential for rapid transition from the lab bench to field use. Their findings are addressed in the article, “Household air pollution: a call for studies into biomarkers of exposure and predictors of respiratory disease,” which is published online by the American Journal of Physiology-Lung Cellular and Molecular Physiology.

The effort is being led by William J. Martin II, MD, Associate Director for Disease Prevention and Health Promotion, Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health (NIH). The team is also comprised of Jamie Rylance, BM BS BMedSci MRCPTM&H, and Stephen Gordon, MA MD FRCP DTM&H, Professor and Chair in Respiratory Medicine, both from the Liverpool School of Tropical Medicine, Liverpool, United Kingdom; Luke P. Naeher, PhD and Olorunfemi Adetona, PhD, both from the University of Georgia, College of Public Health, Department of Environmental Health Sciences, Athens, Ga.; Archana Patel, IMD, DNB, MSCEs, Professor and Head of the Department of Pediatrics, Indira Gandhi Government Medical College, Nagpur, India; John R. Balmes, MD, Professor of Medicine, Division of Occupational and Environmental Medicine, University of California, San Francisco School of Medicine, San Francisco, Ca.; and Derek K. Rogalsky, Georgetown University School of Medicine, Washington, D.C.

Current approaches to HAP assessment, challenges

The researchers found that current HAP assessment tools include direct quantitative measurement of products of incomplete combustion, as well as qualitative methods (including use of questionnaires or the categorization of HAP exposure by type). However, direct exposure assessments via personal monitoring are problematic due to the size, portability and recording capacity of equipment, and acceptability to the user.

Despite the new devices currently being field tested and scaled up for commercial use to address these concerns, specific particulate measurement alone cannot differentiate between the multiple sources of pollution such as mixtures of HAP, tobacco smoke, and outdoor pollution. “The grand challenge to the research community is to produce simple and validated tests that better identify populations that are at risk from HAP, and individual responses to exposure reduction strategies,” according to Dr. Martin.

The researchers also found that current HAP exposure measurement methods are expensive, technically challenging, difficult to use with large population studies, and have substantial limitations, making an urgent case for the development of biomarkers of both exposure and health effects. These findings have led to their call for studies into biomarkers of exposure and predictors of respiratory disease.

Martin and his colleagues note that further development of biomarkers of susceptibility and effect could facilitate large scale studies examining the impact of HAP on health and disease in human populations. In the end, new biomarkers would: (a) improve epidemiological accuracy in association studies with health effect; (b) reduce the cost and complexity of monitoring intervention studies; (c) provide data for educating the public and policymakers about risk; and (d) inform clinicians and the public health community about human environmental exposures that are not well characterized.

Conclusion

China uses more coal than any other nation to meet the energy needs of its one billion citizens. In India, 55 percent of electrical power was generated by coal last year, and as austerity measures in Europe grow stronger, coal is becoming an attractive alternative to natural gas. But the more affordable option could also prove to be the more harmful, and potentially add to the illness and death tolls already linked to HAP exposure.

Martin and his colleagues have put together a comprehensive overview of the dangers posed by biomass fuels and the research gaps in assessing HAP threats. The article is a “must read” for anyone interested in public health.

 Study: Household air pollution: a call for studies into biomarkers of exposure and predictors of respiratory disease

Source: EurekAlert!

Positive Clinical Breast Cancer Data Presented for NuView’s Molecular Imaging Biomarker NLS-VPAC1

NuView Life Sciences (NLS), a privately-held company developing next generation imaging diagnostic biomarkers with the ability to identify and locate disease in the earliest stages of development, today announced the presentation of positive clinical results for its Breast Cancer imaging agent NLS-VPAC1 (TP3805) at the 2nd World Congress on Ga-68 in Chandigarh, India on Feb 28th. NuView Life Sciences possesses exclusive worldwide commercialization rights to NLS-VPAC1.

Mathew Thakur, Ph.D., academic collaborator, Professor of Radiology and Director of Radiopharmaceutical Research and Molecular Imaging at Thomas Jefferson University (TJU), Philadelphia, presented data from his investigator-lead, Phase 1 feasibility study that imaged Breast Cancer in 19 patients by utilizing NLS-VPAC1 (labeled with the radioisotope 64Cu) with PET (positron emission tomography) and PEM (positron emission mammography). NLS-VPAC1 unequivocally identified 100% (n=20) of the malignant lesions, irrespective of their hormonal status. In addition, NLS-VPAC1 detected four sentinel lymph nodes (100%). NLS-VPAC1 imaging can be performed within 15 minutes of injection and does not require patient fasting or monitoring of their glycemic levels (unlike F-18-fluorodeoxyglucose (FDG-PET), which is not a cancer-specific agent). Due to this rapid tumor uptake, NuView is additionally investigating use of NLS-VPAC1 labeled with the shorter half-lived isotope gallium-68. This pharmaceutical labeled with Ga-68 can be produced by generators at local radiopharmacies. NLS-VPAC1 imaging can be performed on any current or future PET-based instruments.

“We are very pleased about the results of NLS-VPAC1, these data are consistent with our hypothesis and its potential for non-invasive detection and localization of malignant tumors in the breast and potentially other tissues like prostate, bladder and lung,” stated Dr. Thakur.

“There are over 1.6 Million invasive breast biopsies performed each year in the U.S. at an average cost of $5,500 and over 80% result in a benign diagnosis,” stated Paul Crowe, CEO of NuView Life Sciences. “These results are an encouraging step for NuView and Dr. Thakur. NLS-VPAC1 clearly has the potential to provide early and accurate diagnosis to the physician, reduce pain and discomfort to the patient, and reduce the heavy financial burden on healthcare payors.”

NuView plans to initiate a multi-center Phase2 clinical trial in Breast Cancer in 2013. In addition, NuView and Dr. Thakur have been awarded a $2.6MM grant from the National Institutes of Health (NIH) to conduct an investigator-led, Phase 1 feasibility study with NLS-VPAC1 in Prostate Cancer patients. Planned initiation of this trial is 4Q 2013.

Source: PR Web

Trovagene Announces Commercial Launch Timelines for HPV Carrier and Oncogene Mutation Tests

Trovagene, Inc. (NASDAQ: TROV) recently announced that the development of its proprietary, urine-based HPV carrier screening test is progressing well and the Company expects to achieve analytical and clinical validation of the test in its CLIA laboratory in March 2013. When validation is completed, the test will be available to clinicians and their patients. In addition to the ongoing HPV validation studies, one clinical trial has been completed in India and two additional trials are underway in collaboration with the Barretos Cancer Center, Brazil and Strand Life Sciences, India.

The Company has extended its planned offering of urine-based oncogene mutation tests for 2013 to include a test for the detection of a specific p53 mutation and a specific double mutation in the hepatitis B virus (HBV). Both markers are strongly associated with hepatocellular carcinoma (HCC), which is the third leading cause of cancer mortality worldwide. Availability of the HCC test is anticipated in the fourth quarter of 2013. Trovagene’s KRAS oncogene mutation test is expected to be introduced in the second quarter 2013. In support of the Company’s BRAF oncogene mutation test, a clinical trial with MD Anderson focused on mutations in patients with advanced or metastatic cancers is ongoing. It is anticipated that sufficient clinical specimens will be obtained to support a third quarter offering of this test. Additional clinical studies, including a trial to evaluate the detection of PIK3CA oncogene mutations, are in preparation.

Source: Trovagene

GVK Biosciences and Onconova Therapeutics Establish Novel Joint Development Partnership to Advance New Drugs for Cancer

GVK BIO, Asia’s leading Contract Research and Development organization and Onconova Therapeutics, a U.S. based biopharmaceutical company primarily focused on discovery and development of novel small molecules for Oncology, today announced that they have entered into a novel joint partnership to develop new drugs for Cancer.