Two novel imaging agents and 6 clinical assays for use in cancer care gained the FDA’s approval in 2016, marking advances in the diagnostic field during a relatively slow year for new oncology drugs.
In terms of new assays, the FDA approved following tests in 2016:
Vysis CLL FISH Probe Kit
The Vysis CLL FISH Probe Kit was approved as a companion diagnostic to venetoclax (Venclexta), a BCL-2 inhibitor intended for patients with chronic lymphocytic leukemia (CLL) following at least 1 prior therapy. The kit, which contains 5 reagents sufficient to process 20 assays, also can be used to assess untreated patients.
The Vysis CLL FISH Probe Kit was approved in April 2016, and is manufactured by Abbott Molecular.
Ventana PD-L1 (SP142) Assay
The Ventana PD-L1 (SP142) assay, approved as a complementary diagnostic for atezolizumab (Tecentriq), assesses whether patients who have bladder cancer have PD-L1 in their tumor tissue. This will help practitioners treating patients with bladder cancer decide if atezolizumab, a PD-L1 inhibitor, is the best treatment option after platinum-based chemotherapy.
The Ventana PD-L1 (SP142) assay was approved in May 2016, and is manufactured by Ventana Medical Systems, Inc.
cobas EGFR Mutation Test
The cobas EGFR Mutation Test v2 was approved for use with plasma samples as a companion diagnostic for the non–small cell lung cancer (NSCLC) drug erlotinib (Tarceva). This is the first FDA approval of a liquid biopsy test as an aid in clinical decisions, and makes the cobas EGFR Mutation Test v2 the only FDA-approved test for the detection of the EGFR
gene in DNA derived from plasma or tumor tissue.
With this test, the presence of specific NSCLC mutations [exon 19 deletion or exon 21 (L858R) substitution mutations] detected in patients’ blood samples aids in selecting patients who may benefit from treatment with erlotinib. However, if such mutations are not detected in the blood, then a tumor biopsy should be performed to determine if the mutations are present. If the test shows positive results, it may benefit patients who may be too ill or unable to provide a tumor specimen for EGFR
The cobas EGFR Mutation Test v2 was approved in June 2016, and is manufactured by Roche Molecular Systems.
QuantideX qPCR BCR-ABL IS Kit
The FDA has given marketing approval to the first nucleic acid–based test for quantifying BCR-ABL1 fusion transcripts as a tool for monitoring patients with chronic myeloid leukemia (CML) who are receiving tyrosine kinase inhibitor therapies directed at the mutation.
The QuantideX qPCR BCR-ABL IS Kit, which uses whole blood specimens, demonstrated a high level of analytical sensitivity in human RNA. The company said the test could detect BRC-ABL1 RNA in ≥95% of patients at MR 4.7 (log molecular reduction from 100% IS).
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