CLN - Regulatory Roundup
Roche recently announced CE certification of the newly updated cobas 6800/8800 systems 2.0.
The updated systems are designed to enhance laboratory efficiency by optimizing resources, reducing downtime, consolidating test menus and increasing throughput, all aimed at providing a more streamlined diagnostics experience for healthcare professionals and patients.
The majority of the cobas test menu is available with the release of the update, including the new temperature-activated generation of signal technology. It enables simultaneous detection of up to 15 targets in a single patient sample on the high throughput molecular diagnostic analyzers cobas 5800, 6800 and 8800.
“[The update is a] competitive leap forward in our efforts to advance PCR technology by combining unprecedented throughput together with the flexibility that laboratories require to deliver for physicians and patients,” Roche officials said.
The cobas 6800/8800 systems are designed to serve mid-to-high volume molecular testing laboratories.
Following the European approval, Roche plans to apply for 510(k) clearance from the Food and Drug Administration for these systems in 2025.
Qiagen has received Food and Drug Administration (FDA) clearance for the first test in a series of QIAstat-Dx Gastrointestinal Panel tests for clinical use.
The clearance involves the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, which covers five bacterial and viral causes of gastrointestinal illness, including Campylobacter, Salmonella, Shiga-like toxin E.Coli, and Shigella.
The test quickly multiplies many genetic targets using real-time PCR technology, delivering results in about 1 hour with less than 1 minute of hands-on time. Cycle threshold values and amplification curves give laboratories additional information regarding coinfections, according to Qiagen.
Soon, Qiagen plans to submit to FDA a second version of the gastrointestinal panel covering the same five gastrointestinal pathogens.
Qiagen also plans to submit for FDA clearance QIAstat-Dx Rise, a high-capacity diagnostic instrument. It provides comprehensive testing for up to 160 tests per day using eight analytical modules instead of four, the company said.
bioMérieux has announced Food and Drug Administration special 510(k) clearance for its Biofire Filmarray Tropical Fever (TF) Panel.
Tropical fever infection presentations are often nonspecific and overlapping, complicating efforts to distinguish mild illness from more severe diseases that require prompt and targeted treatment. This new PCR testing solution offers fast and accurate pathogen identification in patients with unexplained fevers, the company said.
The newly cleared panel has six targets, including Chikungunya, Dengue (serotypes 1, 2, 3, & 4), Leptospira, Plasmodium species, Plasmodium falciparum, and Plasmodium vivax/ovale. With a run time of about 50 minutes, the panel differentiates between Plasmodium falciparum and Plasmodium vivax/ovale and may help healthcare providers target appropriate malaria treatment faster.
The panel runs on the fully automated Biofire Filmarray 2.0 and Biofire Torch Systems with only 2 minutes of sample preparation time, according to bioMérieux.
Foundation Medicine recently announced it has received Food and Drug Administration (FDA) approval for its FoundationOne Liquid CDx test to be used as a companion diagnostic for Tepmetko (tepotinib).
Tepmetko received accelerated FDA approval in 2021 and traditional approval in 2024 for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations (METex14). FoundationOne Liquid CDx is the first FDA-approved companion diagnostic to identify patients who may be eligible for Tepmetko.
NSCLC accounts for approximately 85% of lung cancers, 3%–4% of which are associated with METex14. METex14 skipping alterations in patients have been associated with advanced disease and a poor prognosis, Foundation Medicine said.
Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. Using a routine blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights, according to the company.
The New York State Department of Health has approved Solvd Health to offer the state’s residents AvertD, the company’s opioid use disorder (OUD) risk test.
This Food and Drug Administration-approved test assesses individual genetic susceptibility to OUD, providing valuable information to guide personalized pain management strategies.
Solvd Health said approval of its lab is a pivotal step in its mission to expand access to genetic testing that can help address the opioid crisis by informing decisions about pain management to potentially prevent adverse outcomes.
Nuclein recently received Food and Drug Administration (FDA) 510(k) clearance and a CLIA waiver for its Dash SARS-CoV-2 & Flu A/B Test for use on the Dash Rapid PCR System.
The Dash SARS-CoV-2 & Flu A/B Test seamlessly integrates into existing workflows and delivers actionable results for COVID-19, influenza A and influenza B within a single patient visit, according to Nuclein.
The Dash Rapid PCR System enables point-of-care PCR results in only 15 minutes, a speed that is typically only available with antigen tests. The system is designed to offer low-cost, highly sensitive and specific results, with robust multiplexing across various sample types, Nuclein added. It also requires less than a minute of hands-on time.The system’s ease of use and fast turnaround time make it a practical tool for a wide range of healthcare settings, especially urgent cares, student health centers, physician offices, pharmacies, and emergency rooms, Nuclein said.
Altona Diagnostics has received the certificate for compliance with all applicable requirements of the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR) for their PCR testing products, the company announced.
The certificate allows the company to launch its CE-IVD marked products under the IVDR, starting with the AltoStar Parvovirus B19 PCR Kit 1.5 in early 2025. The PCR test detects and quantifies parvovirus B19-specific DNA in human plasma. Parvovirus B19 frequently infects transplant and immunocompromised patients.
The launch of 13 AltoStar assay products, including panels for transplant and immunocompromised patients, will follow later this year.