Pang Nghee Kheem Brendan MBBS (Singapore), FRCPath (UK)

Angsana Diagnostics and Parkway-Pantai Laboratory Services Ltd.

On 30th November 2017, the US Food and Drug Administration approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing (NGS)-based in vitro diagnostics (IVD) test that detects genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The Centers for Medicare and Medicaid Services (CMS) at the same time proposed coverage of the F1CDx.

The test is the second IVD to be approved and covered after overlapping review by the FDA and CMS under the Parallel Review Program, which facilitates earlier access to innovative medical technologies for Medicare beneficiaries, the first being the MSKCC IMPACT NGS panel, on 17th November in the same month.

Compared to other companion diagnostics previously approved by the FDA that match one test to one drug, the F1CDx is a more extensive test that provides information on a number of different genetic mutations that may help in the clinical management of patients with cancer. Additionally, based on individual test results, the new diagnostic test could identify which patients with any of the five tumor types may benefit from 15 different FDA-approved targeted treatment options that were available in 2017. Its results provide patients and health care professionals access to all of this information in one test report, avoiding duplicative biopsies. This talk will showcase, with explained clinical examples, the benefits of a comprehensive NGS-based cancer profiling approach to patient care and discuss emergent trends in CDx testing.

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