Recent FDA moves widen molecular demand
FDA actions this week—like approval of subcutaneous nivolumab for all solid tumors and multiple gene-therapy and drug approvals—will likely drive demand for rapid tumor typing and companion diagnostics routed through cytology and molecular labs. These regulatory changes are reshaping diagnostic pipelines and test volumes. (cancernetwork.com) (pharmexec.com) (bloomberg.com)
Opdivo Qvantig (nivolumab + hyaluronidase-nvhy) was approved by the FDA for subcutaneous injection across most adult, solid-tumor nivolumab indications on December 27, 2024, making it the first subcutaneously administered PD‑1 inhibitor. (fda.gov) The pivotal Phase 3 CHECKMATE‑67T trial that supported the subcutaneous approval randomized 495 patients and was designed as a noninferiority comparison to IV nivolumab. (esmo.org) NCCN guidance and manufacturer materials list specific tumor sites where the subcutaneous formulation may substitute for IV nivolumab — including non–small cell lung cancer, bladder, renal cell, melanoma, head and neck, esophageal/gastroesophageal, gastric, colorectal, and hepatocellular carcinoma. (opdivohcp.com) Multiple professional bodies and studies show cytology specimens (EBUS‑FNA, effusions, cell blocks, smears, and supernatants) are validated substrates for PD‑L1 IHC and molecular assays, and PD‑L1 testing has been performed successfully on cytology cell blocks in large NSCLC cohorts. (cdn.ymaws.com) The FDA approved KRESLADI (marnetegragene autotemcel) for pediatric severe leukocyte‑adhesion deficiency‑I (LAD‑I) due to biallelic ITGB2 variants on March 26, 2026, with the indication limited to patients without an available HLA‑matched sibling donor for allogeneic HSCT. (fda.gov) The Kresladi approval is coupled with commercial incentives and launch planning following FDA clearance, including attention to priority review outcomes that affect market timing for confirmatory genetic testing and treatment pathways. (fiercepharma.com) Biogen’s high‑dose SPINRAZA (nusinersen) regimen received FDA approval March 30, 2026 based on the DEVOTE trial and specifies 50 mg loading doses with 28 mg maintenance dosing in the approved regimen. (bloomberg.com) SMA diagnosis and treatment initiation require identification of biallelic pathogenic variants in SMN1 via molecular testing (PCR/sequencing), and established lab protocols and newborn‑screening workflows are the standard routes for that testing. (emedicine.medscape.com) A multicenter study of EBUS‑TBNA cytology showed 90.1% adequacy for PD‑L1 testing in 387 NSCLC cases, and optimized cytology workflows have reported sequencing success rates up to ~93% when non‑FFPE cytology substrates are validated for NGS. (link.springer.com) AMP/CAP/ASC guidance and institutional protocols emphasize ROSE, targeted passes, and validated triage into cell blocks/non‑FFPE media to maximize nucleic‑acid yield from cytology samples for companion diagnostics and gene panels. (amp.org)
