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Biotech Team Develops ELISA Protocol for COVID-19 Antibody Detection

The new detection method can help determine whether patients have had COVID-19 and if they might still have immunity to the disease.

Michael Barbella, Managing Editor 01.22.21
FDA Grants Emergency Use Authorization for COVID-19 Rapid Antibody Fingerstick Test

The serology test can be used in point-of-care settings, delivering results in 15-20 minutes.

Business Wire 01.21.21
Diagnostics

EKF Introduces Accurate Quantitative COVID-19 Antibody Test Kit

The test kit is one of first to detect both the presence and precise levels of COVID-19 neutralizing antibodies.

EKF Diagnostics 01.05.21
Diagnostics

Abbott's COVID-19 IgG Quantitative Antibody Test Wins EU Approval

Identifies levels of IgG antibodies that attach to the virus' spike protein.

Abbott Laboratories 12.16.20
Diagnostics

Roche's Elecsys Anti-SARS-CoV-2 S Antibody Test Earns EUA

Detects antibodies against the SARS-CoV-2 spike protein.

GlobeNewswire 12.02.20
Diagnostics

GenScript's SARS-CoV-2 Neutralizing Antibody Detection Kit Wins EUA

Only EUA authorized virus-free testing assay that detects neutralizing antibodies within an hour.

PR Newswire 11.09.20
Diagnostics

Genalyte's Rapid COVID-19 Antibody Test Obtains EUA

Instrument-based, rapid test uses multi-antigen approach.

PR Newswire 10.16.20
Diagnostics

Beckman Coulter's SARS-CoV-2 IgM Antibody Test Receives EUA

The test demonstrates 99.9 percent specificity and 98.3 percent sensitivity.

PR Newswire 10.09.20
ASTM International Signs MoU With New Zealand’s National Standards Body

Pact will support Standards NZ’s review and consideration of ASTM standards for reference or adoption as solutions for New Zealand’s industry concerns.

ASTM International 10.09.20
Bodyport Raises $11.2 Million in Series A Funding

Company plans to use the money to launch a virtual cardiac clinic.

Business Wire 09.30.20
Diagnostics

FDA Authorizes First Point-of-Care COVID-19 Antibody Test

Uses blood sample from the fingertip to run the test.

U.S. Food and Drug Administration 09.24.20
Diagnostics

QIAGEN to Launch Digital, Portable COVID-19 Antibody Test

Access Anti-SARS-CoV-2 is an easy-to-use 10-minute test on a portable device that provides highly accurate results on Total Ig antibodies.

QIAGEN 08.26.20
Diagnostics

Siemens Healthineers Obtains EUA for Semi-Quantitative Antibody Test

The SARS-CoV-2 IgG Antibody Test offers the first EUA for a semi-quantitative assay to help clinicians assess the level of an individual‘s immune response.

Business Wire 08.05.20
Diagnostics

Precipio Releases COVID-19 Antibody Test

Tests will be initially rolled out as a CLIA test run in Precipio's lab.

GlobeNewswire 07.31.20
Diagnostics

Luminex Gains EUA for COVID-19 Antibody Test

Third Luminex COVID-19 test to receive EUA since March.

PR Newswire 07.20.20
Diagnostics | Testing

Alliant Offers COVID-19 Antibody Test Kits

Allows individuals to screen for both IgG and IgM strands of the coronavirus.

Globe Newswire 07.06.20
Neurological

FDA Approves Axonics' r-SNM System for 3T Full-Body MRI Scans

The company's sacral neuromodulation (SNM) devices treat urinary and bowel dysfunction.

Business Wire 07.02.20
Diagnostics

Beckman Coulter's SARS-CoV-2 IgG Antibody Test Receives FDA EUA

The company is able to deliver more than 30 million tests a month.

PRNewswire 06.29.20
Diagnostics

Virality Diagnostics Gains EUA for Rapid COVID-19 Antibody Test

Delivers easily interpreted results within 15 minutes.

PR Newswire 06.26.20
Diagnostics

Babson Diagnostics' SARS-CoV-2 IgG Antibody Test Receives EUA

Enables qualitative detection of IgG antibodies to SARS-CoV-2 with 100 percent sensitivity and specificity.

Business Wire 06.25.20
Diagnostics

FDA Pulls EUA for Chembio's COVID-19 Antibody Test

Test generates a higher than expected rate of false results.

U.S. Food and Drug Administration 06.17.20
How Are MPO’s Top 30 Addressing COVID-19?

J&J's Janssen moves the start of its Phase 1/2a vaccine clinical trial from September to the first half of July.

Online Exclusives Sam Brusco, Associate Editor 06.09.20
Diagnostics

FDA Publicly Shares Antibody Test Performance Data

Advancing access to trustworthy tests and the wider field of research into serology testing.

U.S. Food and Drug Administration 06.05.20
Diagnostics

Eurofins Launches COVID-19 Total Antibody Assay

Serology-based IgG, IgA, and IgM detection ELISA assays to aid in rapid identification.

Business Wire 06.04.20
Diagnostics

Siemens Healthineers' SARS-CoV-2 Total Antibody Test Earns EUA

Has demonstrated 100 percent sensitivity and 99.8 percent specificity in identifying SARS-CoV-2 antibodies.

Business Wire 06.01.20
Diagnostics

Siemens Healthineers Ships Antibody Test and Molecular Test Kit for COVID-19 Worldwide

The test has demonstrated 100% sensitivity and 99.8% specificity in identifying SARS-CoV-2 antibodies.

Siemens Healthineers 05.26.20
Diagnostics

FDA Removes Some COVID-19 Antibody Tests from the Market

Includes tests voluntarily withdrawn by manufacturers and those with no pending EUA request.

U.S. Food and Drug Administration 05.22.20
Diagnostics

Roche's COVID-19 Antibody Test Now Available at U.S. Lab Sites

LabCorp and more than 20 other commercial and hospital labs will be able to perform over 2 million tests per week by June.

PR Newswire 05.20.20
Diagnostics

Ortho Clinical’s Second COVID-19 Antibody Test Receives CE Mark

Company's IgG test demonstrates 100 percent specificity and can support convalescent plasma screening.

Ortho Clinical Diagnostics 05.19.20
Diagnostics

Ortho Clinical Diagnostics Granted CE Mark for COVID-19 Total Antibody Test

Company plans to manufacture several million coronavirus antibody tests each month.

Ortho Clinical Diagnostics 05.13.20
Diagnostics

Ortho Clinical Diagnostics, Quest to Broaden Availability of COVID-19 Antibody Testing

Quest will use Ortho’s IgG antibody test to test 3 million patients per month for coronavirus antibodies.

Ortho Clinical Diagnostics 05.12.20
Diagnostics

Abbott’s COVID-19 Antibody Blood Test Gains EUA for Use on Alinity i System

Plans to ship nearly 30 million antibody tests globally in May across its Architect and Alinity i platforms.

PR Newswire 05.11.20
Diagnostics

Mologic and BioSure Partner on COVID-19 Antibody Self-Test

Design is suitable for an at home self-test, giving results in 10 minutes.

Mologic Ltd. 05.11.20
Diagnostics

PerkinElmer's Serological COVID-19 Antibody Test Earns EUA

Test has 99 percent specificity and 100 percent sensitivity after 21 days following the onset of symptoms.

PerkinElmer 05.05.20
Diagnostics

FDA Grants EUA to Roche's COVID-19 Antibody Test

The serology test has a specificity greater than 99.8% and sensitivity of 100% (14 Days post-PCR confirmation).

Roche 05.04.20
Diagnostics

Hardy Diagnostics Gains EUA for COVID-19 Rapid Antibody Test Kit

Partnership with Autobio Diagnostics Co. enables firm to become exclusive U.S. supplier of assay that detects IgM and IgG antibodies.

Newswire.com 04.29.20
Diagnostics

Quest Diagnostics Launches Consumer-Initiated COVID-19 Antibody Test

Individuals can purchase the test online through QuestDirect.

PRNewswire 04.28.20
Diagnostics

LabCorp COVID-19 Antibody Tests Become Available Nationwide

No upfront out-of-pocket costs will be included.

LabCorp 04.28.20
Genalyte Announces Availability of High-Speed COVID-19 Antibody Test

First instrument-based, rapid test uses multi-antigen approach to achieve best-in-class sensitivity and specificity.

PR Newswire 04.28.20
Ortho's Second COVID-19 Antibody Test With 100 Percent Specificity Debuts

Tests will aid in responsible back-to-work assessment, according to manufacturer.

Ortho Clinical Diagnostics 04.27.20
Electronics | Patient Monitoring

Sensors Woven into a Shirt Can Monitor Vital Signs

Comfortable, form-fitting garments could be used to remotely track patients' health.

Massachusetts Institute of Technology 04.24.20
Diagnostics

WytCote Introduces Three-Minute COVID-19 Antibody Test

The company has applied to the FDA for Emergency Use Authorization.

PR Newswire 04.24.20
FDA OKs Baxter's Oxiris Blood Purification Filter for COVID-19 Treatment

Only filter set available in the U.S. to reduce pro-inflammatory cytokine levels in the blood.

Baxter 04.24.20
Electronics | Patient Monitoring

Sweat-Powered Electronic Skin Can Monitor Health

Can be embedded with sensors to measure heart rate, body temperature, levels of blood sugar, and metabolic byproducts .

California Institute of Technology 04.23.20
Diagnostics

FDA Clears Siemens Healthineers' Aidan AI

The latest technology enables new features and enhanced security.

Siemens Healthineers 04.22.20
EarlySense Names New Senior Vice President of Strategic Partnerships

Former Cerner and Allscripts executive joins company to deepen existing relationships and broaden new global opportunities.

EarlySense 04.22.20
Non-Traditional Thinking Can Help Drive Medtech R&D

Non-healthcare-related companies like Google, Amazon, and Apple can provide the medtech industry with unique solutions to age-old problems.

Online Exclusives Michael Barbella, Managing Editor 04.21.20
Diagnostics

FDA Update: COVID-19 Antibody Test Validation and Education

Results from these tests can help identify who has been infected and developed antibodies.

U.S. Food and Drug Administration 04.20.20
Diagnostics

Mologic Launches New Lab-Based COVID-19 Antibody Tests

With manufacturing support from Omega Diagnostics, the laboratory-based test aims to deliver up to 46,000 results per day.

Mologic Ltd. 04.20.20
Diagnostics

Gold Standard Diagnostics Releases Three COVID-19 Antibody Tests

The IgA, IgG, and IgM assays are formatted for optimal functionality in diagnostic laboratories.

Business Wire 04.17.20