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Home » About Us » Our Staff » Articles Authored by Madeleine Johnson

Articles Authored by Madeleine Johnson

May 14, 2020

FDA Requiring Real Patient Samples for Emergency Use Authorization of COVID-19 MDx Tests

With the US now awash in positive samples, assay developers seeking authorization will no longer be allowed to use contrived samples.

Apr 24, 2020

Startup Dropworks Finalizing Digital PCR System for 2021 Launch

Premium

The firm's Continuum system is fully automated and performs the entire digital PCR workflow in a single instrument.

Apr 23, 2020

Curative, KorvaLabs Partner to Create High-Throughput COVID-19 Oral Fluid Testing Lab

The partners received Emergency Use Authorization last week for a test that uses oral fluids, and the lab has capacity to test up to 10,000 samples per day.

Apr 22, 2020

FDA to Harmonize COVID-19 Data with New Terminology Codes

The agency plans to work with a number of partners to develop codes that will describe tests and results to standardize data collection.

Apr 22, 2020

Dutch Firm Molecular Biology Systems Validating Rapid Thermal Cycler for COVID-19 Testing

MBS has developed a compact endpoint PCR system which can test more than 22,000 patient samples per day by performing eight-minute thermal cycling.

Apr 16, 2020

Atila Isothermal qPCR Coronavirus Test Proves Easy to Use, Sensitive in Preliminary Evaluations

The Atila iAMP test was granted Emergency Use Authorization earlier this week and is being evaluated in multiple US labs.

Apr 01, 2020

Nuclein Exits Stealth Mode With Disposable Handheld qPCR System, COVID-19 Test

The firm had been in stealth mode, but hopes to now attract partners to further commercialize its system for decentralized testing.

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.

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The Scan

Free of Influence

Public health experts call for a transparent COVID-19 vaccine approval process in a letter; the Food and Drug Administration commissioner assures science-based approval.

Avoiding the MARCH1 to 1-Mar Change

The Verge reports that new gene-naming guidelines aim in part to avoid Excel-related name change confusion.

Nature Papers Reveal Tuatara Genome, Cell Populations Involved in Lupus

In Nature this week: tuatara genome sequence aids in understanding amniote evolution, and more.

Overlooked Expertise

According to the Guardian, UK virologists say in a letter to officials that their expertise has been pushed aside in COVID-19 response plans.

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