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Genetic Markers Laboratory Developed Tests

Wilson Sonsini Goodrich & Rosati

CMS Expands Coverage of Certain Advanced Cancer Companion Diagnostic Tests Employing Next Generation Sequencing

Recently, the Centers for Medicare & Medicaid Services (CMS) decided to provide nationwide reimbursement for certain in vitro, companion diagnostic tests that employ Next Generation Sequencing (NGS) for patients with advanced...more

Epstein Becker & Green

Obstacles in the Path? Medicare’s National Coverage Determination on Next-Generation Sequencing Has Significant Implications for...

Epstein Becker & Green on

A controversial new Medicare national coverage determination (“Medicare NCD”) for certain next-generation sequencing (“NGS”) tests published by the Centers for Medicare & Medicaid Services (“CMS”) on March 16, 2018, could...more

Hogan Lovells

FDA Cleared First DTC Genetic Tests for Health Risks

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

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