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Articles Authored by Madeleine Johnson

Apr 01, 2020

Despite Potential, Experts Debate Whether Decentralized MDx for Coronavirus Can Flatten Curve

Bringing testing closer to patients could be helpful, provided enough tests and instruments can be manufactured and distributed.

Mar 29, 2020

Bio-Rad Laboratories ddPCR Shows Accuracy Benefits in COVID-19 Detection Studies

Droplet digital PCR tests for SARS-CoV-2 can potentially detect the very low viral loads seen in asymptomatic and convalescent cases.

Mar 26, 2020

FDA Fleshes Out Emergency Guidance for Coronavirus Test Developers

The agency provided an overview of its policies regarding COVID-19 test regulations, as well as additional color and clarification, in a webinar.

Mar 24, 2020

Q&A: FIND's Cassandra Kelly-Cirino Discusses COVID-19 Diagnostics Pipelines

The Foundation for Innovative New Diagnostics is tracking commercial coronavirus diagnostics development project, with the goal of guiding procurement.

Mar 20, 2020

Coronavirus Sample Collection Tool Shortages Will be Short-Lived, According to Suppliers

A number of manufacturers say that the shortage of swabs and transport media for facilitating SARS-CoV-2 testing that clinicians are facing will soon abate.

Mar 20, 2020

Commercial Coronavirus Test Developers Tweak Timelines, EUA Plans in Light of Loosened FDA Guidance

Test makers are preparing to ramp up production of new SARS-CoV-2 assays and designated testing systems in anticipation of increased demand.

Mar 12, 2020

Mesa Biotech Prepping Handheld Coronavirus Molecular Diagnostic System for EUA

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The firm will be validating the test with collaborators in China, and plans to pursue Emergency Use Authorization both in China and the US.

Mar 11, 2020

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

Directing lab-developed tests through the emergency use authorization process has brought to light reagent supply shortages and other hurdles.

Mar 05, 2020

Coronavirus Dx Emergency Use Authorizations Progressing Rapidly Despite Criticism

SARS-CoV-2 viral material is available for test validation, and the FDA is conducting a rolling review process with an abbreviated submission template.

Mar 03, 2020

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

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The agency issued guidance noting that labs can test only the most challenging sample type and can use inactivated virus spiked into negative samples. 

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The Scan

Genomics to Trace, Prevent

Nature News reports that genomics is being applied to trace and try to prevent additional COVID-19 waves.

Sense of Scope in San Diego

Rady's Children Hospital and San Diego County are teaming up to test pediatric patients and their families for COVID-19 to gauge the spread of the virus locally, according to the San Diego Union-Tribune.

Boost to Wolf Diversity

Wildlife managers aim to boost the genetic diversity of Mexican gray wolves by placing captive-born foster pups into packs with similarly aged wild pups, the Mercury News reports.

Science Papers Present Algorithm to Diagnose Slowly Progressing Diseases, Korean Genome Project

In Science this week: Genetic Probability tool identifies likely diagnoses in 45 percent of inflammatory arthritis cases, and more.

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