real-time PCR Diagnostics News

Apr 03, 2020

LetsGetChecked Targets Front-Line Healthcare Workers With New, Two Part SARS-CoV-2 Test

The company's approach relies on an initial point-of-care lateral flow assay followed by a confirmatory real-time PCR analysis run in its laboratories.

Apr 03, 2020

Becton Dickinson, BioGX Get FDA Emergency Use Authorization for Rapid SARS-CoV-2 Test

The test, run on the BD Max system, allows hospitals to diagnose SARS-CoV-2 on site and receive results in less than three hours.

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 27, 2020

Avellino Labs Receives FDA Emergency Use Authorization for Coronavirus Test

The AvellinoCoV2 real-time PCR test is designed for the detection of nucleic acid from SARS-CoV-2 from nasopharyngeal and oropharyngeal swab specimens.

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 18, 2020

Point-of-Care Coronavirus Test From Credo Diagnostics Biomedical Gets CE Mark

The test from Singapore-based Credo requires minimal training to run and can detect pathogens in 20 minutes, with about one minute of hands-on time.

Mar 14, 2020

Thermo Fisher Coronavirus Test Gets FDA Emergency Use Authorization

The test, authorized March 13, runs on the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument and targets three regions of the SARS-CoV-2 genome.

Mar 13, 2020

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

The test is the third to receive EUA, following tests from the CDC and New York state, and it runs on Roche's Cobas 6800 and 8800 systems.

Mar 12, 2020

DIAMONDS Project Using New Classification Approach to Develop Rapid Infectious Disease Tests

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Technology partners on the study include BioMérieux and SkylineDx, as well as Imperial College London's biomedical electronics unit.

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.

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real-time PCR

LetsGetChecked Targets Front-Line Healthcare Workers With New, Two Part SARS-CoV-2 Test

Becton Dickinson, BioGX Get FDA Emergency Use Authorization for Rapid SARS-CoV-2 Test

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

Avellino Labs Receives FDA Emergency Use Authorization for Coronavirus Test

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

Point-of-Care Coronavirus Test From Credo Diagnostics Biomedical Gets CE Mark

Thermo Fisher Coronavirus Test Gets FDA Emergency Use Authorization

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

DIAMONDS Project Using New Classification Approach to Develop Rapid Infectious Disease Tests

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

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Breaking News

Luminex Preliminary Q1 Revenues Rise 10 Percent

CDC Providing $186M for SARS-CoV-2 Response

Yikon Genomics Barred From Selling at-Home COVID-19 Tests Under Settlement With LA

BGI, Aid Genomics Partner to Build COVID-19 Testing Lab in Gaza

MBio to Receive $1.5M in New DARPA Funding for Point-of-Care Diagnostic System

Mass General, CHOP, Northwestern Med Get FDA EUAs for SARS-CoV-2 Tests

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Becton Dickinson, BioGX Get FDA Emergency Use Authorization for Rapid SARS-CoV-2 Test

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

LetsGetChecked Targets Front-Line Healthcare Workers With New, Two Part SARS-CoV-2 Test

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