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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British Medical Laboratory Test for Early Screening of Lung Cancer Shows Promising Interim Results in Large Trial; Could Lead to Other Simple Blood Tests for Cancer Detection

EarlyCDT-Lung test followed by X-rays and CT scans proves up to five times more likely to detect cancer than current standard of care

Encouraging preliminary results from a 12,000-person clinical trial into the effectiveness of a non-invasive medical laboratory blood test for the early detection of lung cancer could signal an advance that leads to creation of similar anatomic pathology screening tests for the early detection of other cancers.

Interim results of a study using the potentially life-saving blood test EarlyCDT-Lung were presented on December 6, 2016, at the International Association for the Study of Lung Cancer’s 17th World Conference on Lung Cancer in Vienna, Austria. Initial results from the trial indicated the blood test can detect lung cancer potentially up to five years before symptoms develop. (more…)

Genetic Tests and Precision Medicine Start to Win Acceptance by Some Payers; Pathologists and Clinical Laboratories Have Opportunity as Advisors

UnitedHealthcare to cover Foundation Medicine’s comprehensive genomic profiling assay for solid tumors, but Medicare still reluctant to reimburse for genetic tests

Studies showing success of targeted therapies in cancer care may be having an influence on the decisions by certain health insurers to reimburse clinical laboratories to reimburse for certain genetic tests.

One example that press reports cite is how last December UnitedHealthcare began reimbursing for a certain genetic test for patients with a particular lung cancer, according to a statement from Foundation Medicine (NASDAQ:FMI). Based in Cambridge, Massachusetts, Foundation Medicine describes itself as “a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer.” (more…)

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…)

New Clinical Laboratory Test Exposes Cancer Cells with Ultra Violet Light: Improves Accuracy of Current Cancer Assays, Say Researchers

New technology accurately distinguishes between cancerous cells and healthy cells. Will it give pathologists a “universal” assay for cancer diagnosis?

In England, a university team has developed a new technology for detecting circulating cancer cells in blood. Their method uses ultraviolet light and the results are so promising that efforts are now underway to develop this method into a clinical laboratory test.

That is why pathologists and medical laboratory professionals may soon have a new tool in their arsenal: one that significantly aids physicians and medical laboratories in the diagnosis of cancer. (more…)

New studies in UK and at Stanford University Show Lung Cancer Cells Circulating in Blood; Findings Could Make it Possible for Pathologists to Diagnose Cancer with ‘Liquid Biopsies’

Researchers at two different universities find circulating tumor cells in blood specimens and suggest that CTCs might be incorporated into medical laboratory tests for detecting cancer

One goal of many research initiatives is to develop a clinical laboratory test which can detect circulating tumor cells (CTC) in blood. This would be a less invasive method for testing and it is hoped such a test could detect cancer at a much earlier stage, when treatment can be much more successful.

Much effort is being put into developing what pathologists call a “liquid biopsy.” Recently, researchers at The University of Manchester in the United Kingdom (UK) and at Stanford University in the United States each published articles in Nature Medicine offering compelling data about the role blood tests could play in the diagnosis and treatment of lung cancer. (more…)

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