Eurofins companies are developing molecular and serological tests to monitor a hantavirus outbreak linked to the Andes strain, with 11 cases and three deaths reported as of May 12.
The FDA has granted Breakthrough Device Designation to Breath Diagnostics Inc.'s OneBreath, a breath-based test that assesses postoperative pneumonia risk in cardiac surgery patients using a single preoperative sample.
The proposed order would shift these test systems to Class II with special controls, replacing the current PMA requirement for companion diagnostics and related oncology assays.
Greer Massey, PhD, chief scientific officer at Molecular Designs, shares insights on how labs are affected by the rule’s reversal and how they can prepare for future regulatory changes.
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The expansion adds compatibility with Roche’s VENTANA DP 200 and DP 600 scanners and makes AISight Dx the first digital pathology image management system cleared under the FDA’s Predetermined Change Control Plan.
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The agency signals intent to withdraw final rule extending regulatory authority to LDTs following federal court ruling that vacated the regulation.
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The circulating tumor DNA test is designed to identify MRD-positive patients with stage II colorectal cancer who may benefit from adjuvant therapy.
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The risk stratification tool is designed to predict long-term outcomes for patients with non-metastatic prostate cancer.
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Natera has received two new FDA Breakthrough Device Designations for its personalized Signatera ctDNA test.
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Quest Diagnostics will offer a Fujirebio blood test this summer to enhance early detection of Alzheimer’s disease.
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NGS-based MRD testing offers unprecedented sensitivity and breadth in detecting low-frequency leukemic clones.
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AMDI has completed a successful clinical study of its Fast PCR-based Mini Respiratory Panel and earned MDSAP certification.
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A federal court ruled in favor of AMP, striking down the FDA’s attempt to regulate laboratory-developed tests (LDTs) as medical devices.
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Pictor has launched its U.S. headquarters in California to expand access to its affordable, high-performance multiplex proteomics platform.
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Revvity, Inc. has launched the IDS i20, a fully automated, high-throughput platform for ChLIA, enabling labs to consolidate specialty tests.
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A recent court ruling excluding LDTs from FDA regulation highlights the urgent need for the diagnostics industry to modernize oversight.
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The FDA has approved Roche’s VENTANA MET (SP44) RxDx Assay, the first companion diagnostic for lung cancer.
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The ruling overturning the FDA’s new regulations covering LDTs is good news. But the growing anti-science bias could impact healthcare more.Â
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