News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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In the UK, Pathologists Are Watching Phase II of a Clinical Trial for a Breathalyzer System That Uses Only a Breath Specimen to Diagnose Lung Cancer

If the clinical study validates this patient-friendly, non-invasive approach to diagnosing lung cancer, it could eventually mean fewer referrals of tissue biopsies to medical laboratories

For almost a decade, pathologists have seen a regular stream of news stories about technologies that utilize a sample of human breath to diagnose a disease or health condition. Now comes news that just such a diagnostic test for lung cancer is beginning clinical trials in the United Kingdom.

The clinical trials will evaluate breathalyzer technology developed by Engineer Billy Boyle, M.S., Co-founder and President of Operations at Cambridge-based Owlstone Ltd.. The clinical trials of this new breathalyzer technology to detect lung cancer are taking place at two National Health Service (NHS) hospitals: University Hospitals of Leicester and Cambridge’s Papworth Hospital in the United Kingdom.

The reason why so much research is happening in this field will be familiar to clinical laboratory managers and pathologists. Use of volatile organic compound (VOC) biomarkers in breath to diagnose disease is an ideal concept because it is convenient, non-invasive, and well tolerated by patients. However, until the start of this clinical study, researchers have explored the potential of this diagnostic approach for some time, but with limited success. (more…)

Wisconsin Company Developing Breath-based Diagnostic Test Technology that Can Detect Early-Stage Infections within Two Hours of Onset

Hospital-based pathologists may soon gain a new diagnostic assay that could prove effective in detecting hospital-acquired infections more quickly and more accurately than with existing rapid molecular diagnostic tests

Imagine a diagnostic assay designed for hospital settings that uses a specimen of the patient’s breath, can be performed at the bedside, and can detect early-stage infections within two hours of onset. Pathologists and clinical laboratory managers will recognize that a diagnostic test such as this could play a big role in helping hospitals reduce hospital-acquired infections (HAI).

That’s just one application that Madison, Wisconsin-based Isomark has for the new breath analyzer test it is developing. The company says that its diagnostic test is capable of detecting early metabolism and immune system changes based on reading carbon dioxide (CO2) in a patient’s breath.

Canary Could Affect Volume of Clinical Laboratory Specimens

The Isomark Canary Breath Analyzer test (Canary) was specifically designed to identify infections before they have a chance to overwhelm the patient’s immune system. Canary has so many potential uses for identifying infection early that, if the technology were cleared for clinical use, medical laboratories could eventually see a significant reduction in the volume of patient specimens coming into the microbiology department. (more…)

Researchers Determine That Individuals’ ‘Breathprint’ Are Unique; May Have Potential for Clinical Laboratory Testing When Coupled With Mass Spectrometry Technology

Pathologists may be interested to learn that everyone’s breath reveals a signature composition of metabolites that may reflect a lifetime of diet, state of health, illnesses, and exposure to chemicals

New research shows that a person’s “breathprint” is as unique as a fingerprint and may be as effective as bodily fluids in diagnosing diseases. That same research effort is showing that it is feasible to combine breath specimens and mass spectrometry to accurately identify disease. That could give clinical laboratories a new methodology to use when creating diagnostic assays.

These findings are part of a new study conducted by researchers at the Swiss Federal Institute of Technology (ETH Zurich) in Zurich. The study was published by the journal PLOS ONE. (more…)

In Clinical Trials, Breath Test for Lung Cancer Shows Promise for Earlier Detection

Pathologists may do fewer lung biopsies should non-invasive breath testing technology make it into clinical practice

Here’s a medical laboratory test for diagnosing cancer that has the potential to score two runs with one swing of the bat. First, researchers have completed the first clinical trial of a non-invasive cancer test that utilizes a breath specimen.

Second, the subject of this clinical trial was lung cancer—a type of cancer that would benefit from a pathology test that can detect the disease much earlier. This would increase the survival rates for lung cancer, which currently has a five-year mortality rate of 90%.

As many pathologists and clinical laboratory managers know, it is possible to use breath specimens to diagnose a variety of diseases and health conditions. For almost 20 years, breath samples have been used to test for Helicobacter pylori, the bacteria which causes ulcers in the stomach.

Researchers Want to Introduce Breath Analysis into Clinical Pathology Laboratory Testing

Recent advances in breath analyzer technologies may give pathologists new diagnostic tools

Does breath analysis have a promising future in pathology and clinical laboratory testing? That day may not be far off. Scientists in multiple research laboratories are developing cost-effective, non-invasive diagnostic test technologies based on breath specimens from patients.

Researchers say that breath analysis can provide critical information in real time and deliver numerous advantages over fluid and image-based testing. In fact, glucose testing via breath specimen may be just around the corner!

On May 31, 2011, Xhale, Inc. was issued a patent for its system and method for non-invasive monitoring of glucose concentrations in blood to provide critical information in the diagnosis and treatment of diabetes. The Xhale system consists of a small handheld device that analyzes exhaled breath condensate. (more…)