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CLSI Released an Updated Molecular Methods Document on Fluorescence In Situ Hybridization Methods for Clinical Laboratories

Wayne, Pennsylvania, USA—September 2013—The Clinical and Laboratory Standards Institute (CLSI) has published an updated version of MM07-A2—Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline—Second Edition. The second edition of this document addresses fluorescence in situ hybridization (FISH) methods for medical genetic determinations, identification of chromosomal abnormalities, and gene amplification.

MM07-A2 has been reorganized, updated, and improved for better understanding and application. The document includes added examples to illustrate characteristics of FISH tests. Recommendations for probe and assay development, manufacture, qualification, verification, and validation; instrument requirements; quality assurance; and evaluation of results are also included in this edition of the document.

“The document has more examples, more background, and an improved format that I think will facilitate its use by laboratories that want to bring up a new FISH test or understand why the steps they’ve employed in bringing up previous tests are important. It’s the kind of reference that I wish I had had when I first started FISH testing,” noted MM07-A2 document Chairholder, James Mascarello, PhD, of Integrated Genetics, Santa Fe, New Mexico, USA.

MM07-A2 is intended for clinical laboratories that develop and/or use FISH assays and for agencies that regulate those laboratories. To a lesser extent, it may be of value to manufacturers of FISH probes and other reagents used in FISH testing.

This version of MM07-A2 is also fully integrated with the FISH recommendations from the American College of Medical Genetics and Genomics.

CLSI is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at or call 610.688.0100.



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