Quest Diagnostics to Offer Fujirebio Blood Test for Alzheimer’s
Quest Diagnostics will offer a Fujirebio blood test this summer to enhance early detection of Alzheimer's disease.
Tag: CLIA
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Is There a Smart Path to Regulating Laboratory Developed Tests?
Xifin’s CEO sees a window of opportunity for lawmakers to modify the Final Rule on LDTs that will be a win-win for the industry and patients.
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Bio-Rad Laboratories to Present New QC Specifications, Products, and Demos
Bio-Rad Laboratories will showcase its QC solutions at ADLM, including a workshop on adapting lab practices to new CLIA 2024 specifications.
Strong Growth Projected for Liquid Biopsy Market
The Deerborne Group has published a comprehensive analysis of the global liquid biopsy testing market for 2023–2028.
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Innovative Health Diagnostics’ New Platform Enhances Home Testing for Digital Health Companies
IHDLab launched an API platform to help digital health companies enhance the efficiency and scalability of their at-home testing capabilities.
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QuidelOrtho Gets CLIA Waiver for COVID Rapid Test
QuidelOrtho, a provider of innovative in vitro diagnostic technologies designed for point-of-care...
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Fapon to Showcase Diagnostic Solutions at AACC
Fapon will showcase its Shine i8000/9000 ultra-high throughput and fully automatic analyzer at the 2023 AACC Expo.
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Daxor’s Blood Volume Diagnostic Sees Increased Utilization
Daxor Corporation has announced expansion of blood volume analysis (BVA) into five of six hospitals in the Southeast.
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Simple HealthKit Launches At-Home Testing Kits
Simple HealthKit has teamed up with Walmart to make Simple HealthKit’s at-home diabetes, respiratory and sexual wellness tests available.
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Free Web-Based and CLIA Compliant Calibration Verification Data Reduction & Test Reporting Services Offered
Verichem now offers customers free access to the its web-based and online calibration verification data reduction and test reporting programs.
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IBS Test Validated for Use with Finger Stick Whole Blood Collection Technology
The inFoods IBS test has been validated for use with finger stick blood samples simplifying collection and facilitating access to the test.
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Laboratory-Developed Tests: A Best Practices Primer
Most current molecular tests have been developed as laboratory-developed tests, outside the strict regulatory framework of the FDA.
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Verichem Launches Calibration Reference Materials for Urine Chemistries
Verichem Labs now offers a range of multi-level liquid stable biosynthetic clinical reference materials for use with urine chemistry assays.Â
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SEngine Precision Medicine Gets New York CLEP Approval for Tumor Test
SEngine has been certified through the NY State Department of Health’s CLEP program to perform the PARIS Test on samples from the state.
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Precision Health Solutions Launches At-Home Testing Service
Precision Health Solutions launched a new at-home testing service that brings clinical diagnostic testing to the patient’s home.
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Linearity Testing And Calibration Verification In Today’s Clinical Lab
Regulations and guidelines sometimes make it difficult to perform linearity testing and calibration verification in a useful way.Â
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Rapid Novor’s Multiple Myeloma Monitoring Blood Test Gets CLIA Certification
Rapid Novor obtained the CLIA certification for its EasyM assay for Multiple Myeloma as a laboratory developed test.
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Visby Medical’s STI Test for Women Gets FDA Clearance, CLIA Waiver
Visby Medical has received 510(k) clearance and was granted a CLIA waiver from the FDA for its second-generation POC sexual health test.
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