Clinical Lab Management

News on issues related to managing clinical laboratories.

FDA Issues New Guidance for Non-Laboratory SARS-CoV-2 Diagnostic Tests, Pooled Testing

The agency has provided new guidance for tests that can be used outside of a lab setting, as well as updated its guidance on a number of other topics.

FDA Reissues EUA for LabCorp Molecular SARS-CoV-2 Test for Asymptomatic Population, Pooled Testing

The FDA reissued the EUA after analyzing LabCorp data that showed the test could detect SARS-CoV-2 in a general asymptomatic population.

RenalytixAI Receives Approval From New York State to Offer Kidney Test

KidneyIntelX can be used to report risk assessment results for fast-progressing kidney disease and future kidney failure for patients with chronic kidney disease.

Judge Allows Whistleblower Suit Against Myriad Genetics to Proceed

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In January a federal court unsealed a False Claims Act suit from an industry insider that alleges a Myriad subsidiary engaged in a fraudulent kickback scheme.

Quest Diagnostics Receives FDA Emergency Use Authorization for COVID-19 Self-Collection Test Kit

The company said that by the end of June it would have made available more than 500,000 kits, which allow individuals to self-collect nasal samples at home.

May 28, 2020

AMP SARS-CoV-2 Molecular Dx Survey Shows Supply Chain Issues Hampered Ramp Up of Testing

May 20, 2020

Q&A: Dartmouth's Gregory Tsongalis on Implementing Molecular SARS-CoV-2 Tests in the Lab

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Apr 03, 2020

With Sputum Test for SARS-CoV-2, MicroGen Dx Aims to Challenge Quest, LabCorp

Apr 02, 2020

Siemens Healthineers Developing Molecular Kit for Coronavirus Detection

Mar 19, 2020

Quest Diagnostics Receives Emergency Use Authorization for SARS-CoV-2 Test

Mar 17, 2020

Quidel Nabs FDA Emergency Use Authorization for Coronavirus Assay

Mar 16, 2020

FDA Grants Emergency Use Authorization for Coronavirus Assays From Hologic, LabCorp

Mar 15, 2020

House Passes Bill to Cover Coronavirus Testing with Emergency Use Authorization

Mar 14, 2020

Thermo Fisher Coronavirus Test Gets FDA Emergency Use Authorization

Mar 13, 2020

FDA Issues Emergency Use Authorization for Roche SARS-CoV-2 Test

Mar 11, 2020

Chan Zuckerberg Initiative, UCSF, Stanford Partner to Boost Bay Area Coronavirus Testing

Mar 11, 2020

In Coronavirus Assay Validation for Emergency Use, Labs Encounter Multiple Pain Points

Mar 10, 2020

Coronavirus Detection Kits from LGC Biosearch Technologies Authorized by CDC for Emergency Use

Mar 09, 2020

Hologic to Receive $699K From BARDA for Rapid Development of High-Throughput Coronavirus Test

Mar 05, 2020

German Research Project Shows Feasibility of SARS-CoV-2 Testing Using Hologic LDT Functionality

Mar 05, 2020

Commercial Labs Step up Coronavirus Test Efforts After FDA Guidance

Mar 03, 2020

FDA Provides SARS-CoV-2 Test Validation Guidance for High-Complexity Labs Seeking EUA

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Mar 02, 2020

NY State Labs Get FDA Emergency Use Authorization for SARS-CoV-2 Test

Feb 29, 2020

FDA Allows High-Complexity CLIA-Certified Labs to Perform Coronavirus Testing

Feb 28, 2020

CDC Revises SARS-CoV-2 Assay Protocol; Surveillance Testing on Track to Start Next Week

The Scan

Up to Him

The Washington Post writes that the approval in the US of a SARS-CoV-2 vaccine will be up to Peter Marks, a career official at the Food and Drug Administration.

Study of Racism in Academic Research

According to ScienceInsider, the US National Academies of Science, Engineering, and Medicine is planning a study of racism in academic research.

Kodak Loan on Pause

NPR reports the US loan to Eastman Kodak to boost domestic pharmaceutical production is on pause following insider trading allegations.

Cell Studies on Blood Immune Features in Severe COVID-19 Cases, Alzheimer's Spatial Transcriptomes

In Cell this week: blood immune cell changes in COVID-19 patients and spatial transcriptomics in Alzheimer's disease.

Featured White Papers

AIM-MNP: Implementation of Molecular Profiling in Pediatric Brain Cancer A GenomeWeb eCase Study Transcript

Best Practices Guide for Selecting Laboratory Refrigerators

Demystifying the Medical Grade Refrigerator

OptiCool Cooling System in Helmer Scientific GX Cold Storage Solutions: Technology and Benefits

Aug

18

Featured Webinar

COVID-19 Wastewater-Based Epidemiology: Methods and Insights for SARS-CoV-2 Community Surveillance

As worldwide COVID-19 cases continue to rise, there is a significant need to increase testing and population surveillance capacity.

Aug

19

Featured Webinar

Case Study: An IVD Manufacturer’s Experience Building a Complete Sample-to-Result Workflow

This webinar will present a case study from in vitro diagnostics developer SpeeDx on its experience building a complete sample-to-result workflow — encompassing instrumentation and data analysis software — for its qPCR-based ResistancePlus MG Mycoplasma genitalium assay.

Aug

25

Featured Webinar

Liquid Biopsy-based Molecular Risk Stratification of ALK-mutated Lung Cancer Patients

Non-small cell lung cancer (NSCLC) patients with ALK rearrangements are treated with tyrosine kinase inhibitors (TKIs), which often leads to prolonged overall survival. However, treatment resistance will almost inevitably occur, and the disease remains incurable.

Aug

26

Featured Webinar

Resolving Complex Haplotypes Implicated in Alzheimer’s and Other Neurodegenerative Diseases

Alzheimer’s disease is genetically complex with no meaningful therapies or pre-symptomatic disease diagnostics.

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Clinical Lab Management