In its final report on gaps in the oversight of genetic testing, the Department of Health and Human Services (HHS) Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) has urged the Centers for Medicare & Medicaid Services (CMS) to increase proficiency testing in this rapidly expanding market. The panel also said, in the report released April 30, that the Food & Drug Administration should expand its regulation to all lab tests, including lab-developed tests (LDTs).

In its main FDA recommendation related to clinical validity, SACGHS said the agency should "address all laboratory tests in a manner that takes advantage of its current experience in evaluating lab tests." In comments on the previous draft, lab and pathology groups argued that the CMS CLIA program should have the lead oversight role for genetic testing, in particular over LDTs, while the FDA should have a consultative role.

June 2008 - Table of Contents

DTTR June 2008 (full PDF issue)

SACGHS Report Calls for Expanded FDA Oversight

Myriad Genetics to Expand Direct-to-Consumer Marketing Efforts

FDA Clears Third Warfarin Genotyping Test

Congress Passes Ban on Genetic Discrimination, Measure Ready for Signing

Genzyme Genetics Launches Testing for Spinal Muscular Atrophy

Inverness Completes Acquisition of Matria Healthcare

SACGHS Calls for Expanded Regulation, Resources for Genetic Testing

Part B Lab Spending Climbs to $6.8 Billion in 2007

LabCorp Expands Companion Diagnostic Development Focus

Beckman Coulter Licenses HCV Test from Siemens

Group B Strep Increases Among Adults

NEJM Study Finds Genetic Links to Neuroblastoma

Saliva-Based Method Shows Promise for Early Diagnosis of Heart Attack

Enzo Biochem Buys Biomol to Boost Life Sciences Business

IVD Stocks Lose 4%; Affymetrix Drops 34%

Outreach Testing by the Numbers