Investigational Blood Test Detects ALS Up to 10 Years Before Symptoms Appear
Johns Hopkins-led study identifies protein signature with 98% accuracy in distinguishing ALS patients from healthy individuals and those with other neurological diseases.
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FDA Issues Notice to Rescind Laboratory Developed Test Rule
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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Every week, we dig into the biggest shifts, breakthroughs, and tech transforming clinical diagnostics. Straightforward, insightful, and always relevant.Critical Resources
Diagnostic Innovations
Liquid Biopsy Assay Shows Superior Sensitivity in Head-to-Head Study
The assay detected 51% more pathogenic variants and 109% more copy number variants compared to six commercial liquid biopsy assays in prospective validation study.
Equipment & Supply Spotlight
Seegene Unveils Fully Automated PCR System and Real-Time Analytics Platform
CURECA and STAgora technologies aim to eliminate manual intervention in molecular testing workflows and provide actionable diagnostic data insights.
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Disease Detection & Understanding
AliveDx Registers MosaiQ Multiplex Testing Platform as Class II Exempt Device with FDA
The registration enables US clinical laboratories to adopt the multiplexed testing platform for autoimmune diseases and allergies.
