Personalized Medicine: 2021 FDA Guideposts for Progress – Focus On Diagnostics

11 March 2022 Personalized Medicine Bulletin Blog
Author(s): Antoinette F. Konski

Last week I reported on The Personalized Medicine Coalition’s (PMC) recently released PERSONALIZED MEDICINE AT FDA: The Scope & Significance of Progress in 2021 (2021 Report) that surveyed U.S. Food and Drug Administration (FDA)-approved personalized therapies. In addition to personalized therapies, the 2021 Report highlights the progress in diagnostic technologies. 

Diagnostic technologies are integral to precision medicine. Physicians and medical researchers use diagnostic tests to determine which medical treatments will work best for each patient.1 Data from diagnostic tests is often combined with an individual’s medical history, circumstances, and values, to provide better therapeutic and preventive care.2

2021 New Approvals and Indication Expansions

In 2021 FDA’s Center for Devices and Radiological Health (CDRH) approved or cleared several significant new or expanded indications for the use of in vitro tests and one whole exome sequencing platform to support the detection of germline variation among the new in vitro tests are Ki-67 IHC MIB-1 pharmDx, the first approved companion diagnostic for the proteomic biomarker (Ki-67) and OncoMate MSI Dx Analysis System, the first cleared PCR-based in vitro diagnostic (IVD) for microsatellite instability (MSI) characterization.3

Also noteworthy were approvals for the following companion diagnostics for detecting or measuring: 1. PD-L1 expression for Tecentriq (atezolizumab) therapy for the treatment of non-small cell lung cancer (NSCLC); 2. mismatch repair deficiency (dMMR) to guide decisions for the use of Jemperli (dostarlimab-gxly) in the treatment of solid tumors; 3. ALK mutations for the use of Lorbrena (lorlatinib) for the treatment of NSCLC; 4. EGFR exon 20 insertion mutations for the use of Exkivity (mobocertinib) for NSCLC; 5. single nucleotide variants in IDH1 for the use of Tibsovo (ivosidenib) for the treatment of cholangiocarcinoma; 6. MET exon 14 skipping mutations to guide the use of Tabrecta (capmatinib) for the treatment of NSCLC; 7. FGFR2 rearrangements for the use of Truseltiq (infigratinib) for the treatment of cholangiocarcinoma; 8. BRAF V600E mutations for the use of BRAF inhibitors for the treatment of metastatic melanoma; 9. blood-based EGFR exon 20 insertions for the use of Rybrevant (amivantamab-vmjw) for NSCLC; and 10. blood-based KRAS G12C for the use of Lumakras (sotorasib) for NSCLC.4

FDA also authorized a whole exome sequencing platform (Helix® Laboratory Platform) to support the detection of germline variation and cleared the Helix® Genetic Health Risk App for late-onset Alzheimer’s disease for OTC use on the Helix® Laboratory Platform.

Expanding the Knowledge Databases of Genetic Variants

FDA also granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB) as the first tumor mutation database as part of FDA’s database recognition program. The database provides an “expertly curated database of the biologic and clinical implications of thousands of cancer-associated mutations."5

Diagnostic Support for Personalized Therapies

New promising therapies are important to advancing the health of our nation’s population. Equally important are the diagnostic tests that identify patients most likely to benefit from a particular therapy or prophylactic intervention. PMC’s 2021 Report highlights the diagnostic advances made in 2021, further advancing precision medicine. 


1 2021 Report at page 3.

2 Id.

3 2021 Report at page 13.

4 2021 Report at pages 14-15.

5 2021 Report at page 16.

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