CLN - Regulatory Roundup
Siemens Healthineers recently announced that its Atellica IM High-Sensitivity Troponin I blood test has received Food and Drug Administration clearance for helping identify patients at risk of major cardiac events and death for up to 1 year, a new claim for a test previously cleared only for detecting acute myocardial infarction.
Many U.S. hospitals use the test to measure cardiac troponin I. Now, for chest pain patients without a heart attack diagnosis, the Siemens Healthineers Atellica IM TnIH test may give information about their impending risk after presenting to the emergency department with signs and symptoms of acute coronary syndrome.
The test runs on the Atellica Solution, Atellica CI Analyzer, and ADVIA Centaur platforms. With a 10-minute time to first result, the Atellica IM TnIH test now can be used as an aid in prognosis for 30-, 90-, 182-, and 365-day all-cause mortality and major adverse cardiac events (MACE) in patients presenting with signs and symptoms suggestive of acute coronary syndrome.
MACE consists of myocardial infarction, urgent revascularization, cardiac death, or heart failure hospitalization, according to Siemens Healthineers.
Qiagen recently announced Food and Drug Administration clearance for its QIAstat-Dx Meningitis/Encephalitis Panel for use in various clinical settings to help diagnose central nervous system infections and QIAstat-Dx Respiratory Panel Mini to support clinical diagnosis of upper respiratory infections in outpatient settings.
The QIAstat-Dx Meningitis/Encephalitis Panel simultaneously analyzes several of the most common viral, bacterial, and fungal pathogens responsible for community-acquired meningitis and encephalitis.
The QIAstat-Dx Respiratory Panel Mini is designed to support clinical decision making in diagnosing upper respiratory infections in outpatient settings. It covers five common viral causes of illness: influenza A, influenza B, human rhinovirus, respiratory syncytial virus, and SARS-CoV-2.
The panel uses the QIAstat-Dx system to quickly amplify many genetic targets at the same time using real-time PCR technology, according to Qiagen.
BD has announced Health Canada approval of its BD Onclarity HPV Assay for human papillomavirus (HPV) testing with vaginal specimens patients collect at home.
According to the company, its assay is less invasive, more cost-effective, and requires less frequent use than the traditional Pap test. BD says the test makes cervical cancer prevention more accessible, especially to remote, rural, and vulnerable populations. Cervical cancer incidence is three times higher in underserved populations in remote communities who have limited access to screening when compared with the general population, the company added.
In addition to advancing more equitable access to care, the BD Onclarity HPV Assay is the only Health Canada-licensed test that supports self-collection with HPV extended genotyping to measure a woman's true risk for cervical precancer and cancer more precisely, according to BD.
The New York State Department of Health Clinical Laboratory Evaluation Program has approved the BIOTA-ID Urine NGS assay as a laboratory developed test, Biotia announced.
According to the company, BIOTIA-ID is the first genomics-based urine assay using artificial intelligence approved by the state. It offers 97% sensitivity and 99% specificity for identifying urogenital pathogens, including those often missed by traditional culture methods.
Researchers recently reported that BIOTIA-ID identifies pathogens in 60% of urine samples for which traditional culture-based techniques fail. Seventy percent of patients who gave the samples had been prescribed antimicrobials that were ineffective for the pathogens BIOTIA-ID identified, according to Biotia.
The company said BIOTIA-ID is particularly valuable for patients with complicated and recurrent urinary tract infection or immunocompromised patients, who often face diagnostic challenges and delays in appropriate treatment.
Caris Life Science has announced Food and Drug Administration (FDA) approval for its MI Cancer Seek as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies.
The assay includes one pan-cancer and five tumor-specific indications for various FDA-approved therapies. MI Cancer Seek is the first and only simultaneous whole exome sequencing and whole transcriptome sequencing -based assay with FDA-approved CDx indications for molecular profiling of solid tumors.
MI Cancer Seek uses total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens to detect single nucleotide variants, insertions, and deletions in 228 genes. It also detects microsatellite instability and determines tumor mutational burden.
The tests have several companion diagnostic indications encompassing various biomarkers and drugs.
NeoGenomics recently announced New York State Department of Health conditional approval for its Neo Comprehensive Solid Tumor assay and NeoTYPE DNA & RNA Lung test.
The approvals allow immediate commercial access to these next-generation sequencing tests (NGS) in New York state. The company says they offer better diagnostic value and cost-effectiveness than single gene testing and direct the first-line treatment of diverse solid tumors, including non-small cell lung cancer.
The tests analyze a broad panel of genes, including less common genetic markers that cancer-specific profiles or single-gene tests may miss. Neo Comprehensive offers physicians a pancancer genomic profiling solution that aligns with National Comprehensive Cancer Network guidelines for diverse cancers.
NeoTYPE DNA & RNA Lung uses the same technology as Neo Comprehensive Solid Tumor, but in the context of a more focused NGS panel that focuses on what the company says is an unmet need in lung cancer testing across the state.
Clinical Laboratory News
Contents copyright © 2025 by the Association for Diagnostics & Laboratory Medicine.