Landmark Longitudinal Prostate Cancer Study Released
A new study confirms Cleveland Diagnostics’ IsoPSA test effectively differentiates between low- and high-risk prostate cancer patients.
Tag: CLIA
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LabGenomics USA Acquires CLIA-Certified Lab
LabGenomics USA acquired Integrated Molecular Diagnostics labs and now operates four CLIA-certified diagnostic labs in the U.S.
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Key Proteo’s Clinical Lab Expansion Plans Include New CLIA-Certified Lab
Key Proteo has initiated plans to build a new CLIA-certified laboratory as part of its growth strategy to enhance newborn screening programs.Â
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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How Single-Cancer Testing Could Revolutionize Diagnostics
Veracyte CEO Marc Stapley outlines how single-cancer testing is giving pathologists, clinicians, and patients an edge.
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ProterixBio Offers Quantitative Soluble ST2 Assay for Heart Failure Patients
ProterixBio’s ST2 Assay is for use in conjunction with clinical evaluation in assessing the prognosis of patients with chronic heart failure.Â
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Arima Genomics and Protean BioDiagnostics to Make Gene Fusion Test Available for Clinicians
Arima Genomics announced an agreement with Protean BioDiagnostics to make its next-generation sequencing-based test available to clinicians.
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AMP Commends Congress for Nixing VALID Act
The Association of Medical Pathology (AMP) applauded Congress for not including the VALID Act in the Consolidated Appropriations Act of 2023.
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