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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Hologic panel: FDA's Radiological Devices Panel will weigh in on Hologic's Selenia Dimensions 3-D digital mammography tomosynthesis system on Sept. 24 in Gaithersburg, Md. The firm is seeking PMA approval for both screening and diagnostic indications. The panel is a long time in coming: the firm backed out of a June 2009 panel review to strengthen its case for the product, which it had originally hoped to launch in 2008. The firm most recently forecast approval late this year (1"The Gray Sheet" Feb. 8, 2010). The tomosynthesis technology is designed to address what Hologic calls the primary limitation of 2-D digital mammography, "namely, the superposition of normal breast anatomy that may mask a breast cancer.

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Regulatory News In Brief

Array-based cytogenetic tests: The Cleveland Clinic and the College of American Pathologists disagree on whether cytogenetic diagnostic arrays are ready for prime time, according to July 30 comments to FDA. The agency is carving out a regulatory policy for the complex assays, which detect DNA copy number changes that may indicate disease (1"The Gray Sheet" July 12, 2010). Cleveland Clinic 2cautions that "our current ability to conduct array-based cytogenetic tests exceeds our understanding of the pathophysiology behind some of these findings." Labs should standardize test interpretation and reporting approaches, the clinic writes, and results should be presented by a genetic counselor. The college of pathologists, on the other hand, says the tests "are not unlike numerous other laboratory tests" used today and should not be "unduly restricted" by FDA. "Patient care is compromised when diagnostic testing services are less readily and affordably available because of burdensome regulation," CAP 3writes. The group suggests databases and criteria that could be used to distinguish benign from pathogenic test findings

Regulatory News In Brief

Array-based cytogenetic tests: The Cleveland Clinic and the College of American Pathologists disagree on whether cytogenetic diagnostic arrays are ready for prime time, according to July 30 comments to FDA. The agency is carving out a regulatory policy for the complex assays, which detect DNA copy number changes that may indicate disease (1"The Gray Sheet" July 12, 2010). Cleveland Clinic 2cautions that "our current ability to conduct array-based cytogenetic tests exceeds our understanding of the pathophysiology behind some of these findings." Labs should standardize test interpretation and reporting approaches, the clinic writes, and results should be presented by a genetic counselor. The college of pathologists, on the other hand, says the tests "are not unlike numerous other laboratory tests" used today and should not be "unduly restricted" by FDA. "Patient care is compromised when diagnostic testing services are less readily and affordably available because of burdensome regulation," CAP 3writes. The group suggests databases and criteria that could be used to distinguish benign from pathogenic test findings

Earnings In Brief

AGA Medical: Firm anticipates clearance of its Amplatzer Vascular Plug 4 in the third quarter after answering remaining questions from FDA on the application, AGA Medical CEO John Barr said during an Aug. 3 second quarter earnings call. He noted the questions are "not clinical in nature." The device, which has already launched in Europe, helped drive vascular plug sales up 51% in the quarter to $5.3 million. Corporate sales in the second quarter were $53.8 million, up 7.6% on a reported basis

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