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Biomarkers in Medicine

Highlighting the latest news in biomarkers in medicine

Pages 613-615 | Published online: 15 Aug 2014
Take a Deep Breath: Novel Markers for Larynx Cancer Observed

Volatile organic compounds in human breath can be used as noninvasive biomarkers for head and neck cancers, as well as cancers of the larynx.

A recent study by researchers at the Rey Juan Carlos University (Madrid, Spain) investigated 20 healthy subjects and 11 with cancer of the larynx at various disease stages. The results, published in the journal Chromatographia, revealed that the air exhaled by the T3 stage patients contained different concentrations of seven compounds compared with levels in the healthy control group and those with T1 tumors (less developed). In individuals with advanced cancer, peaks representing ethanol and 2-butanone were particularly significant, suggesting that these two compounds could be potential markers for laryngeal carcinoma.

“At the moment, it is still a preliminary study and a wider sample has to be obtained,” explained study coauthor Rafael García (Rey Juan Carlos University), “but it is a step in the right direction, an alternative with regard to identifying biomarkers, not only for this type of cancer, but for other more prevalent and serious ones such as lung cancer, where early detection is key.”

Study participants were asked to breathe into gas sampling bags following a minimum 8-hour fast to ensure there was no leftover food or drink on their breath. Samples were analyzed using solid-phase microextraction, gas chromatography and mass spectrometry techniques.

The team are set to continue their work to develop sensors capable of detecting disease through breath analysis with García describing the ultimate aim of this research as the creation of an electronic nose for use in hospitals and health centers for early disease detection.

Prostate Cancer Diagnostic Offers more Specificity than Traditional Methods

The Prostate Health Index is now available across the USA, offering more accurate detection of prostate cancer in patients with elevated prostate-specific antigen levels.

Beckman Coulter (CA, USA) have recently announced that their prostate cancer blood test, the Prostate Health Index (phi), is available to physicians throughout the USA. The test has been shown to be three-times more specific than the traditional prostate-specific antigen (PSA) test, thus decreasing the number of men needing biopsies to confirm a diagnosis.

PSA is constitutively expressed by the prostate gland; however, it is often found to be elevated when cancer is present. The current assay therefore tests for elevated levels of PSA. This can however give false positives, caused for instance by a benign inflammation. This would then lead to unnecessary biopsy, and with this, preventable health risks. The phi uses three different biomarkers – PSA, free PSA and p2PSA – and uses an algorithm to determine the probability of cancer. This has been shown to be more accurate than the PSA test, and in a multicenter clinical study, a 31% reduction in unnecessary biopsies was observed.

Senior Vice President of the Chemistry/Immunoassay Business Unit at Beckman Coulter Diagnostics, John Blackwood, commented on the announcement: "After years of collaboration with some of the world's leading prostate cancer researchers and medical institutions who have studied the scientific and clinical benefits of phi, we are pleased that the test is now available to help physicians and patients with an elevated PSA test result more accurately detect prostate cancer.”

VolitionRx and University Hospital Bonn to Commence CE Mark Performance Evaluation

Blood-based diagnostic test developer VolitionRx Ltd (Namur, Belgium) has announced an extension to its agreement with University Hospital Bonn (Bonn, Germany). The hospital will externally conduct the performance evaluation for CE marking of the company's NuQ® assays as a tool for detecting colorectal cancer. The agreement will also lead to an increase in the size of the hospital's prospective study from 2000 to 4000 patients.

The CE mark performance evaluation will be led by Stefan Holdenrieder (University Hospital Bonn). The team will use NuQ kits as a confirmatory trial on patient samples from VolitionRx's ongoing collaboration with Hvidovre Hospital (Hvidovre, Denmark). Holdenrieder will also lead the expanded German prospective study, designed to evaluate the performance of VolitionRx's assays across patients with the 20 most prevelant cancer types, matched healthy individuals and those with competing conditions.

Holdenrieder commented, “VolitionRx has seen some impressive results in recent months, with significant differentiation shown. If the data continues to impress, we believe this technology could have great potential and we want to be at the heart of this research. With that said, we decided to expand our prospective trial and agreed to run the performance evaluation for colorectal cancer. We hope our research further confirms the accuracy of these tests and allows their clinical use in Europe.”

US FDA Approval for a Human Papillomavirus Test for Primary Cervical Cancer Screening

The Society of Gynecologic Oncology welcomed the US FDA's approval of a human papillomavirus (HPV) DNA test for women aged 25 years and older that can be used alone to help a healthcare professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test can also provide information about the patient's risk for developing cervical cancer in the future.

Primary HPV testing will not replace the Pap test, and the Pap will be continued to be used by doctors. FDA approval of primary HPV testing means the HPV test can be used first when screening a woman for cervical cancer. Using a sample of cervical cells, the cobas® HPV Test (Roche, Mannheim, Germany) detects DNA from 14 high-risk HPV types. The test specifically identifies HPV 16 and HPV 18, while concurrently detecting 12 other types of high-risk HPVs, whereas the Pap test identifies precancer and cancer.

Based on results of the cobas HPV Test, women who test positive for HPV 16 or HPV 18 should have a colposcopy. Women testing positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy. Healthcare professionals should use the cobas HPV Test results together with other information, such as the patient screening history and risk factors, as well as the current professional guidelines.

“Today's approval offers women and physicians a new option for cervical cancer screening,” said Alberto Gutierrez, Director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health. “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer.”

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