CLN - Regulatory Roundup
Thermo Fisher recently announced Food and Drug Administration (FDA) approval of its Oncomine Dx Express Test for use as a companion diagnostic (CDx) for Dizal’s Zegfrovy (sunvozertinib) and in tumor profiling.
The approval brings rapid next-generation sequencing (NGS) results in as little as 24 hours to decentralized settings closer to where patients receive care, which aids in timely decision making, Thermo Fisher said.
Approved to run on the Ion Torrent Genexus Integrated Sequencer, the Oncomine Dx Express Test identifies patients with non-small cell lung cancer (NSCLC) who harbor EGFR exon 20 insertion mutations. The test also is approved for profiling solid tumors and detects mutations with evidence of clinical and potential clinical significance in 46 genes.
The Ion Torrent Genexus Integrated Sequencer automates the NGS workflow from sample preparation to data analysis and reporting. It is designed to make NGS accessible to more laboratories, including those that are smaller and lack NGS expertise. The sequencer also enables labs to generate timely CDx results and tumor profiling reports to expedite insights and access to precision oncology.
Zegfrovy, developed by Dizal, received FDA accelerated approval following its breakthrough therapy designation and priority review for treatment of NSCLC patients with EGFR exon 20 insertion mutations. With the approval of the Oncomine Dx Express Test as a companion diagnostic for this therapy, clinicians can now identify eligible patients quickly — and support earlier intervention and expanding access to targeted therapy, Thermo Fisher said.
Fulgent Genetics has received CE certification under the European Union’s In Vitro Diagnostic Regulation 2017/746 (IVDR) for its germline next- generation sequencing system.
The system includes FulgentExome and Fulgent Pipeline Manager (PLM). FulgentExome is a phenotype-driven system designed for clinical analysis to identify germline variants to aid diagnosis of suspected genetic conditions. FulgentExome examines coding region and splice junctions for more than 4,600 genes and reports variants of plausible clinical relevance. Within the FulgentExome system, Fulgent PLM software analyzes genetic information from sequencing data.
FulgentExome may be used as an inclusion test for clinical trials and may help ensure eligibility for reimbursement pathways for public health programs under IVDR, the company said.
Exact Sciences’ Oncodetect molecular residual disease (MRD) test has received Medicare coverage through the Centers for Medicare & Medicaid Services Molecular Diagnostic Services Program for serial use in patients with stage II, III, and resectable stage IV colorectal cancer (CRC) in adjuvant and recurrence monitoring settings over a 5-year period.
The Oncodetect test tracks up to 200 circulating tumor DNA variants and can identify signs of cancer recurrence up to 2 years earlier than imaging alone, according to Exact Sciences.
The company said the Oncodetect test is supported by robust clinical validation studies. These include Beta-CORRECT, which confirmed the test’s prognostic power across stages II−IV CRC, and Alpha-CORRECT, one of the longest-followed MRD cohorts for CRC recurrence.
The test’s integration with the ExactNexus technology platform enables seamless ordering alongside other Exact Sciences Precision Oncology solutions, the company said.
Diasorin has earned 510(k) Food and Drug Administration (FDA) clearance for the Liaison Plex Gram-Positive Blood Culture Assay, a syndromic blood culture panel for the microbiological diagnosis of bloodstream infections on the Liaison Plex platform.
The company also has submitted an FDA 510(k) premarket notification and CLIA waiver application for its Liaison NES, a next-generation molecular point-of-care testing platform.
The Liaison Plex Gram-Positive Blood Culture Assay detects 17 targets — including 13 gram-positive bacteria and four relevant resistance gene targets — in under 2 hours. Targets include Bacillus subtilis and the gene mecC, providing clinicians with the ability to make rapid and targeted treatment decisions.
The submission covers the Liaison NES Flu A/B, RSV, and COVID-19 panel, designed to simultaneously detect and differentiate between four of the most common and clinically significant respiratory pathogens: influenza A, influenza B, respiratory syncytial virus, and SARS-CoV-2.
LEX Diagnostics has submitted dual applications to the Food and Drug Administration seeking 510(k) clearance and CLIA waived status for its VELO system, an ultra-fast point-of-care molecular diagnostics platform.
The platform is designed to deliver highly sensitive PCR results for key respiratory pathogens directly from a swab sample in 6 to 10 minutes.
The LEX system supports multiplex testing for key respiratory pathogens, including influenza A, influenza B, and COVID-19. It is engineered to integrate easily into clinical workflows across primary care settings, urgent care clinics, pharmacies, physician office laboratories, and decentralized acute settings. The system’s proprietary cartridge-based design eliminates the need for external liquid handling, promoting ease of use and reliability.
LEX recently completed clinical studies in the United States with the VELO system and the influenza/COVID assay during the 2024-2025 respiratory season.
The Biocartis Idylla EGFR Mutation Test has received the EU Technical Documentation Assessment and Quality Management System certificate under the European Union In Vitro Diagnostic Regulation.
The companion diagnostic (CDx) detects EGFR exon 19 deletions and the L858R mutation, key biomarkers that guide targeted therapies for patients with non-small cell lung cancer (NSCLC). Designed for use on the Idylla Platform, the test qualitatively detects 44 mutations across exons 18, 19, 20, and 21 of the EGFR gene — all within a single cartridge. Among these, exon 19 deletions and L858R mutations are validated as CDx targets, for which the test has 99.2% sensitivity and 99.0% specificity, respectively. The remaining mutations have
been analytically validated, Biocartis said.
Utilizing formalin-fixed, paraffin-embedded tissue samples, the test is fully automated from sample to result, delivering fast results in under 3 hours, streamlining laboratory workflows, and empowering oncologists to provide timely treatment decisions for their patients, the company said.
Read the full September-October issue of CLN here.