CLN - Regulatory Roundup
The Food and Drug Administration has approved Roche’s human papillomavirus (HPV) self-collection solution, making it one of the first available in the United States, according to the company.
The HPV self-collection solution is approved for use with Roche's cobas HPV test. This test runs on the cobas 4800 and the fully automated cobas 5800/6800/8800 systems, which provide up to 96 results in about 3 hours.
The solution, which is intended for use in healthcare systems, allows the patient to collect their own vaginal sample without a pelvic exam. The healthcare provider then sends the sample to the lab.
Roche hopes that this solution will increase access to HPV screening at a time when more than half of all U.S. cervical cancer patients are insufficiently screened. Each year in the U.S., more than 13,000 patients are diagnosed with cervical cancer and approximately 4,000 die from this preventable disease, caused by HPV infection.
The Food and Drug Administration has approved Pillar Biosciences’ premarket approval supplement application for its oncoReveal CDx pancancer solid tumor test.
The approval expands the indication of oncoReveal Dx from EGFR and KRAS therapy selection in non-small cell lung cancer and colorectal cancer to include general solid tumor profiling.
The test has a fully automated workflow any clinical laboratory can perform, with a sample-to-report time of as little as 48 hours. Approved for use on the Illumina MiSeq Dx System for tumor profiling and therapy selection, the test includes actionable targets on most common solid cancer types and covers 22 clinically relevant genes in one multiplex reaction.
Geneoscopy recently announced Food and Drug Administration approval for its ColoSense noninvasive colorectal cancer (CRC) screening test in adults aged 45 years of age or older who are at typical average risk for developing the disease.
ColoSense is the first noninvasive CRC screening test to provide a dynamic view of disease activity by using RNA biomarkers, according to Geneoscopy. The company chose to target RNA biomarkers with this test because these markers are not subject to age-related methylation patterns, which can lead to test performance variability across different age groups.
The ColoSense CRC-PREVENT study of more than 1,800 average risk individuals ages 45 and older demonstrated 93% sensitivity for detecting CRC and 45% sensitivity for detecting advanced adenomas (AA). In a subgroup of individuals aged 45−49, the test showed 100% sensitivity in detecting CRC and 44% sensitivity for AA.
Geneoscopy plans to launch the test with Labcorp either in late 2024 or early 2025.
HemoSonics has earned 510(k) clearance from the Food and Drug Administration (FDA) for expanded use of arterial blood samples with its Quantra QStat Cartridge, which runs on the Quantra Hemostasis Analyzer.
HemoSonics’ QStat Cartridge first received 510(k) clearance from the FDA in 2022 for use with venous whole blood samples. The more recent clearance enables hospitals to further standardize and operationalize viscoelastic testing with an arterial and venous indication for both HemoSonics’ QStat Cartridge and the QPlus Cartridge.
The Quantra System enables decisions on management of bleeding patients and medically appropriate therapy amidst recent shortages of blood. It provides comprehensive whole-blood coagulation analysis at the point of care or in laboratory-based settings, typically in less than 15 minutes. The system is cleared for use in cardiac, trauma, liver, and major orthopedic surgeries.
The Food and Drug Administration has granted 510(k) clearance to Qiagen for its QIAstat-Dx Respiratory Panel Plus syndromic test.
The panel covers 21 viral and bacterial targets and is designed to support clinical decision-making in diagnosing upper respiratory infections. The panel gives results in about 1 hour, with less than 1 minute of hands-on time. Cycle threshold values and amplification curves are easy to view, according to the company.
The company currently also has a gastrointestinal panel under FDA review along with a meningitis/encephalitis panel.
Diasorin has received Food and Drug Administration clearance for the NxTAG Respiratory Pathogen Panel (RPP) v2. This panel covers many pathogens commonly associated with respiratory infections and has added SARS-CoV-2 to its mix of 19 viral and 2 bacterial targets. The updated panel also provides enhanced target performance to increase inclusivity and specificity, while improving usability of the product with easier-to-identify plate seals.
These product updates integrate with existing features, allowing for testing of up to 96 specimens in a single run. Designed to run on Magpix systems, the NxTAG panel also complements the recently cleared Liaison Plex Respiratory Flex panel. The two syndromic solutions respectively address the need for high throughput batch testing and on-demand random access, the company said.