CLN - Regulatory Roundup
Illumina, Inc., announced Food and Drug Administration (FDA) approval of its in vitro diagnostic (IVD) TruSight Oncology (TSO) Comprehensive test and its two companion diagnostic (CDx) indications.
The company says the test is the first FDA-approved, distributable comprehensive genomic profiling IVD kit with pancancer companion diagnostic claims. The test interrogates over 500 genes to profile a solid tumor, increasing the likelihood of identifying an immuno-oncology biomarker or clinically actionable biomarkers that enable targeted therapy options or clinical trial enrollment.
TSO Comprehensive is approved as a CDx to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions that may benefit from treatment with Bayer’s VITRAKVI (larotrectinib). The test is also approved to identify adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) that may benefit from treatment with Lilly’s Retevmo (selpercatinib).
NTRK gene fusions are rare and can be challenging to detect. The company says that TSO Comprehensive also interrogates RNA and can identify a broad range of known and novel gene fusion partners across all three NTRK gene fusions: NTRK1, NTRK2, and NTRK3. Bayer’s Vitrakvi (larotrectinib) is a highly selective TRK inhibitor approved for use in patients with TRK fusion cancer, in accordance with therapeutic labeling.
A separate CE-marked version of TSO Comprehensive already is available in Europe.
Companion Diagnostic for Synovial Sarcoma Gets FDA 510(k) Clearance
Thermo Fisher Scientific announced that its SeCore CDx HLA A Sequencing System has been granted Food and Drug Administration 510(k) clearance for use as a companion diagnostic with Tecelra (afamitresgene autoleucel), Adaptimmune’s newly approved T-cell receptor (TCR) therapy for certain adult synovial sarcoma patients.
These patients have unresectable or metastatic synovial sarcoma; have received prior chemotherapy; are HLA-A02:01P, -A02:02P, -A02:03P, or -A02:06P positive; and have tumors that express the MAGE-A4 antigen.
Cancer immunotherapies, including TCR therapies, have become increasingly powerful tools in cancer treatment, particularly for patients with metastatic or unresectable tumors. TCRs interact with specific human leukocyte antigen (HLA) proteins to activate an immune response, making high-resolution HLA typing a critical step in identifying patients most likely to benefit from engineered TCR T-cell therapies like Tecelra.
FDA Proposes Reclassification of Hepatitis B Tests
The Food and Drug Administration (FDA) has proposed changing antigen, antibody, and nucleic acid-based hepatitis B virus (HBV) assays to a lower-risk classification.
In the September 25 Federal Register, the FDA notes that these tests, currently classified as class III, or high risk, are subject to premarket approval requirements. The FDA proposes changing the devices to class II, or moderate risk, making them eligible for the 510(k) pathway.
As part of the reclassification, the agency plans to mitigate test risks — false positive and negative results, misinterpretation of results, and failure to correctly operate the devices — by creating special controls for the tests.
The Federal Register notice says the FDA will accept comments on its proposal until November 25.
Guardant360 CDx Liquid Biopsy Approved as Companion Diagnostic in Japan
Guardant Health Japan Corp. recently announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Guardant360 CDx as a companion diagnostic to identify EGFR exon 20 insertion mutations in patients with inoperable or recurrent non-small cell lung cancer (NSCLC) for consideration of treatment with amivantamab-vmjw combined with chemotherapy.
This approval makes the Guardant360 CDx comprehensive genomic profiling panel the first blood-based companion diagnostic to be approved in Japan for this purpose. Janssen Pharmaceutical is currently seeking regulatory approval for the use of amivantamab-vmjw in Japan, according to Guardant.
In a retrospective analysis, the Guardant360 test identified EGFR exon 20 insertion mutations in 2.4% of East Asian patients with NSCLC, including those from Japan. This approval gives patients in Japan with inoperable or recurrent NSCLC harboring EGFR exon 20 insertion mutations a greater opportunity to access targeted treatment options, according to the company.
In March 2022, the agency approved Guardant360 for comprehensive genomic profiling in patients with advanced solid tumors. The test examines 74 cancer-related genes and is approved as a companion diagnostic for multiple cancer drugs approved in Japan.
T2 Biosystems Receives FDA Clearance for Pediatric Candida Panel
T2 Biosystems, Inc., has received Food and Drug Administration clearance for its pediatric T2Candida Panel. The panel detects sepsis-causing Candida species directly from blood in 3 - 5 hours, without the days-long wait for a positive blood culture, the company said.
The test runs on the T2Dx Instrument and simultaneously detects five Candida species, including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata. According to the U.S. Centers for Disease Control and Prevention, these species account for up to 95% of all Candida bloodstream infections in the U.S.
T2 Biosystems officials cited studies showing the T2Candida Panel detects Candida species significantly faster and with greater sensitivity than blood culture-based diagnostics. They added the test would help clinicians improve outcomes and reduce costs by achieving faster targeted antifungal treatment for their pediatric patients.
Foundation Medicine Announces Additional Tissue and Liquid Biopsy Test Approvals
Foundation Medicine, Inc., announced Food and Drug Administration (FDA) approval for its FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics for AstraZeneca’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).
This FDA decision follows approval of FoundationOne for Lynparza to identify mCRPC patients with homologous recombination repair gene alterations and the approval of FoundationOne Liquid CDx for Lynparza to identify patients with BRCA1, BRCA2, and/or ATM alterations in mCRPC.
Foundation Medicine officials noted the approval helps meet “a critical unmet need for first-line treatment options for patients with BRCA-mutated [mCRPC] and this combination therapy is an important advancement.” The most recent approval reinforces the importance of testing for genomic mutations at metastatic diagnosis to help guide treatment decisions, they added.
Read the full November/December 2024 CLN issue here.