CLN - Regulatory Roundup
Roche’s Elecsys Neurofilament Light Chain (NfL) test received CE mark approval for the detection and assessment of neuroinflammation in patients diagnosed with relapsing-remitting multiple sclerosis, the company recently announced.
The blood test measures the NfL protein to detect neuroinflammation associated with multiple sclerosis. It gives clinicians a minimally invasive way to monitor the biological damage caused by the disease. The assay could help make more regular monitoring a reality for more people living with the disease and result in earlier and better-informed clinical management, Roche said.
Performed on Roche’s widely available cobas instruments, the Elecsys NfL test provides standardized and consistent results and ensures reliable insights regardless of where the test is carried out, the company said.
Although early and regular monitoring of disease activity plays a critical role in treatment optimization, some patients can find it difficult to access routine assessments such as MRI scanning that would allow timely detection of changes in their condition. With traditional testing for multiple sclerosis often limited by geographic, financial, or logistical barriers, Elecsys NfL will make frequent monitoring more practical and accessible, according to Roche.
Natera recently announced Food and Drug Administration (FDA) approval of Signatera CDx as a companion diagnostic for use with adjuvant Tecentriq (atezolizumab) immunotherapy in muscle-invasive bladder cancer (MIBC). Specifically, this approval authorizes the use of Signatera CDx to identify patients with MIBC who are circulating tumor DNA minimal residual disease (MRD)-positive and may benefit from Tecentriq treatment.
This follows the October 2025 New England Journal of Medicine publication of results from the global Phase III IMvigor011 trial, which was sponsored by Genentech, the company that developed Tecentriq. The trial results demonstrated that Signatera MRD-positive patients treated with immunotherapy achieved significant improvements in disease-free survival and overall survival (OS), while Signatera MRD-negative patients achieved 97% 2-year OS with no adjuvant therapy at all.
According to Natera, this is the first companion diagnostic approval in the field of blood-based MRD.
Agilent Technologies recently received Food and Drug Administration (FDA) approval for PD-L1 IHC 22C3 pharmDx, Code SK006, as the only companion diagnostic to help identify patients with esophageal or gastroesophageal junction (GEJ) carcinoma who may be eligible for treatment with Keytruda (pembrolizumab), Merck’s anti-programmed cell death protein 1 therapy.
Keytruda is indicated for the treatment of patients with locally advanced or metastatic esophageal or GEJ (tumors with epicenter 1–5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express programmed death-ligand 1 (PD-L1) with a combined positive score of 1 or greater.
The FDA previously approved other companion diagnostic indications for the test with Keytruda, including nonsmall cell lung cancer and esophageal squamous cell carcinoma; cervical cancer and head and neck squamous cell carcinoma; triple-negative breast cancer; gastric or GEJ adenocarcinoma; and epithelial ovarian, fallopian tube, and primary peritoneal carcinoma.
Guardant Health recently earned Food and Drug Administration (FDA) approval for its new Guardant360 Liquid CDx.
The test is the largest FDA-approved liquid biopsy panel, assessing a 100-times wider genomic footprint than the previously approved Guardant360 CDx.
Companion diagnostic indications for the previously approved version of Guardant360 CDx transfer to the newly approved version of Guardant360 Liquid CDx, according to the company. The newer version uses Guardant’s Smart Platform, which integrates genomic and epigenomic profiling from a single blood draw, providing a several-fold increase in sensitivity for circulating tumor DNA detection compared to the previous version.
The newer test is also the first liquid biopsy to simultaneously define genotype and key phenotype information. It delivers results in as few as 7 days, providing information for clinical decisions regardless of tissue availability, line of therapy, or practice setting, according to Guardant.
Laguna Diagnostics has received Food and Drug Administration (FDA) breakthrough device designation for its mRNA Gene Biomarker Test, designed to help differentiate schizophrenia and bipolar disorder in symptomatic patients.
Research suggests misdiagnosis rates for these conditions may exceed 50%, with current methods often requiring up to 3 years to reach a conclusion, Laguna said.
The test uses mRNA biomarker signatures from a blood sample to generate an objective probability score. The test is intended for use in conjunction with clinical assessment and other patient information.
Laguna said the designation is based on study results showing a 96.7% sensitivity for schizophrenia, 100% specificity for bipolar I disorder, and 98.3% overall accuracy.
The FDA designation does not guarantee marketing approval. Laguna said it is pursuing further validation studies.
Foundation Medicine recently announced that it received Food and Drug Administration (FDA) approval for its FoundationOne CDx as a companion diagnostic for Tepmetko (tepotinib) to identify patients with metastatic nonsmall cell lung cancer harboring MET exon 14 skipping alterations.
The announcement follows an initial approval in November 2024, when the FDA first approved FoundationOne Liquid CDx as a companion diagnostic to identify patients who may be eligible for Tepmetko from a blood plasma sample. With the more recent approval, the FDA now allows both tissue and liquid biopsy approaches from Foundation Medicine’s tissue and liquid biopsy tests to be used to identify patients who may be eligible for tepotinib treatment.
The recent approval for FoundationOne CDx is the first to include the company’s real-world data-based service. It supports drug and diagnostic label expansion by supplementing clinical trials with curated real-world evidence and integrated regulatory support. Drawing on data from more than 150,000 patients in the Flatiron Health-Foundation Medicine Clinico-genomic Database, Foundation Medicine can generate relevant and harmonized real-world data cohorts. These reduce the need for incremental patient enrollment and maintain the rigor required for regulatory use in companion diagnostic projects, the company said.