News — Bethesda, MD, April 20, 2015: The Association for Molecular Pathology (AMP), the premier global, non-profit organization serving molecular diagnostic professionals, today published a special article in The Journal of Molecular Diagnostics titled, 鈥淒o Circulating Tumor Cells, Exosomes, and Circulating Tumor Nucleic Acids Have Clinical Utility?鈥 The report provides a thorough overview of research to-date on the minimally invasive 鈥渓iquid biopsy鈥 approaches to cancer diagnostics.

鈥淎s a group of molecular diagnostic experts, we were intrigued and excited by the emerging technologies that are likely to find utility in patient management,鈥 said co-author Milena Cankovic, PhD, Henry Ford Health System and past AMP Clinical Practice Committee member. 鈥淲e set out to review and compile the leading research literature as a primary reference source for continued exploration.鈥

More than 200 studies are cited in the paper, providing a substantial digest of research to-date. "Our literature survey concluded that measuring circulating tumor cell burden in metastatic breast and prostate cancer has already crossed a prognostic threshold for clinical utility. That's why the FDA cleared a device for this purpose. It's likely that several other analytes, like circulating tumor DNA, will meet this threshold in the next few years," said first author, Bert Gold, PhD, National Cancer Institute.

In general, the article supports the notion that this type of diagnostic testing in and of itself allows for earlier diagnosis, faster and more targeted treatment, reduced costs, and increased quality of life and even increased lifespan for the patient. The article also includes recommendations for future trials that will ultimately lead to demonstrating the clinical utility of the referenced minimally invasive approaches. 鈥淭hese areas of cancer molecular diagnostics have been promising for quite a while,鈥 said senior author, Christopher D. Gocke, MD, Johns Hopkins University. 鈥淲e hope that researchers will take this review of circulating tumor nucleic acids and circulating tumor cells as a spur to do the large studies needed to push the technology across the finish line. This would be a win for the field, for our patients, and for the concept of precision medicine.鈥

While many of the studies referenced were smaller and examined only one or a few markers, progress has already been made in testing methods to increase accuracy and validity of samples. The initial results are promising, according to the authors.

ABOUT AMP:The Association for Molecular Pathology (AMP) was founded in 1995 to provide structure and leadership to the emerging field of molecular diagnostics. AMP's 2,300+ members include individuals from academic and community medical centers, government, and industry; including pathologist and doctoral scientist laboratory directors; basic and translational scientists; technologists; and trainees. Through the efforts of its Board of Directors, Committees, Working Groups, and members, AMP is the primary resource for expertise, education, and collaboration in one of the fastest growing fields in healthcare. AMP members influence policy and regulation on the national and international levels, ultimately serving to advance innovation in the field and protect patient access to high quality, appropriate testing. For more information, visit .

CONTACT:Nicole Litchfield, on behalf of AMPBioscribe Life Science [email protected]

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