The Clinical and Laboratory Standards Institute has published an updated version of “MM07-A2–Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline–Second Edition.” This document addresses 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 when I first started FISH testing,” noted MM07-A2 document chairholder James Mascarello, PhD, of Integrated Genetics, Santa Fe, NM.
This version of MM07-A2 is fully integrated with the FISH recommendations from the American College of Medical Genetics and Genomics and is intended for clinical laboratories that develop or use FISH assays and for agencies that regulate those laboratories. It may also be of value to manufacturers of FISH probes and other reagents used in FISH testing.
CLSI, 610-688-0100