CLN - Regulatory Roundup
Polymedco has received Food and Drug Administration 510(k) clearance for its Pathfast high-sensitivity cardiac troponin I (hs-cTnI-II) assay, making this the first hs-cTn test cleared for point-of-care use in the U.S., according to the company. Developed for Polymedco’s Pathfast Biomarker Analyzer, the test aims to facilitate the accurate, rapid diagnosis of myocardial infarction in near patient settings.
The timing of troponin test results is critical for patient diagnosis and care. Prior to this clearance, hs-cTn was available only in the hospital central laboratory, and results could take an hour or more to reach the physician, Polymedco said in a statement. In contrast, the Pathfast platform delivers results in 17 minutes at the point of care.
With this clearance, the test may be sold in the U.S. for use on the Pathfast analyzer with whole blood and plasma patient specimens. Results should be used in conjunction with other diagnostic information, such as electrocardiogram, clinical findings, and patient symptoms.
The Food and Drug Administration has granted expanded clearance and a CLIA waiver to Cepheid’s Xpert Xpress MVP, a multiplex vaginal panel. The test can be performed now in near-patient settings, enabling results within 60 minutes from a single specimen for bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis. The test runs on Cepheid’s GeneXpert Xpress instruments and has been approved for testing for women 14 years of age and older.
Diagnosis of vaginitis is often made through a clinical examination. Sometimes clinicians prescribe treatment regimens that may not be appropriate for a patient’s specific infection. Because the causative agents are from three distinct pathogen classes, but present with similar symptoms, a precise diagnosis afforded by multiplexed PCR testing can enable more targeted and timely treatments.
Cepheid officials hope that the addition of the CLIA waiver will allow physicians to quickly and accurately identify their patient’s infection and prescribe the correct treatment regimen, with the goal of avoiding multiple office visits associated with therapeutic failure.
Hologic’s new Genius Digital Diagnostics System with the Genius Cervical AI algorithm has received Food and Drug Administration clearance. The company said the digital cytology system combines deep-learning-based artificial intelligence (AI) with advanced volumetric imaging technology to help identify precancerous lesions and cervical cancer cells.
Currently, cytologists and pathologists typically review glass slides with patients’ cervical cells under a microscope. In contrast, the Genius Digital Diagnostics System allows digital imaging of the slides and cells. An AI algorithm then identifies the cells that cytologists and pathologists should review.
According to Hologic, the new process and technology demonstrated an overall improvement in sensitivity without a corresponding decrease in specificity.
The Food and Drug Administration has cleared Immunexpress’ EDTA blood compatible cartridges for use with SeptiCyte Rapid, a host response molecular test for sepsis. Clinical labs in the U.S. can now use the updated SeptiCyte Rapid cartridges with undiluted EDTA blood in place of proprietary PAXgene blood RNA tubes, an option that has been available in Europe since August 2022.
Immunexpress’ EDTA cartridges were validated in a multisite study conducted at University Hospitals in Cleveland, Case Western Reserve University, and other healthcare systems. The research was partly funded by a contract from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services. BARDA awarded this grant to Immunexpress in 2020 as part of the Drive Solving Sepsis program.
The Food and Drug Administration has granted clearance to T2 Biosystems for its expanded T2Bacteria Panel, which now detects the bacterial species Acinetobacter baumannii (A. baumannii). A. baumannii causes bloodstream infections, which can range from benign transient bacteremia to septic shock. These infections pose risk to seriously ill patients in intensive care units, on ventilators, with catheters or open surgical wounds, or who have prolonged hospital stays.
The T2Bacteria Panel also detects Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Escherichia coli.
Diasorin has earned Food and Drug Administration 510(k) clearance for its new Liaison Plex platform as well as for the platform’s first panel, the Liaison Plex Respiratory Flex Assay.
The Liaison Plex is designed to allow customization of syndromic panels. The fully automated sample-to-answer system has a streamlined workflow with room-temperature stable consumables. The operational hands-on time is only 2 minutes per sample and results are produced in less than 2 hours, according to Diasorin.
The Liaison Plex Respiratory Flex Assay tests for 19 pathogens commonly associated with respiratory infections, including 14 viral and 5 bacterial targets detected from nasopharyngeal swabs. Unlike most panel tests, which give users results for all targets at once, Flex testing allows users to generate and pay for a subset of specific results based on a patient’s clinical picture.
Chugai Pharmaceutical Company has received approval from Japan’s Ministry of Health, Labour, and Welfare to offer Foundation Medicine’s FoundationOne CDx Cancer Genomic Profile test. The test is approved to be used as a companion diagnostic with Eli Lilly Japan’s rearranged during transfection (RET) receptor tyrosine kinase inhibitor, Retevmo capsules (selpercatinib), a therapeutic for RET fusion-positive solid tumors. With this approval, clinical labs in Japan can now use this test to detect RET fusion genes in order to determine whether a patient could benefit from selpercatinib. Chugai officials said that the test is useful for determining a treatment plan for patients because, in addition to detecting a rare RET fusion gene, it also detects other extremely rare genetic mutations that are expressed across cancer types.