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  QIAGEN Granted EUA for Digital COVID-19 Antibody Test

  eHub digital device can handle eight tests at once, all working independently of each other, and can process up to 32 samples per hour.

  Business Wire 07.15.21
  

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  Ultra-Fast COVID-19 Antibody Test Under Development

  Test could be used worldwide to help prioritize who should receive coronavirus vaccines.

  Business Wire 07.01.21
  

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  Bodyport Names Amit Rushi as Chief Commercial Officer

  Phyllis Whiteley, Ph.D., is appointed board chairman.

  Michael Barbella, Managing Editor 06.04.21
  

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  BrainChip, Biotome Partner on COVID-19 Antibody Test

  The goal is to produce a handheld device that can provide accurate results in seconds.

  Michael Barbella, Managing Editor 05.19.21
  

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• Neurological
  

  Rice Researchers Seek to Create an Implant That Controls the Body’s Circadian Clock

  Could halve the time it takes to recover from jet lag and similar disruptions to the body's sleep/wake cycles.

  Charles Sternberg, Assistant Editor 05.14.21
  

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  FDA Grants EUA to Beckman Coulter's COVID-19 Antibody Test

  Assay being rolled out in laboratories throughout the New York City metropolitan area.

  Michael Barbella, Managing Editor 05.11.21
  

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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
  

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  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
  

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• 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
  

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• 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
  

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• 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
  

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• 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
  

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• Diagnostics
  

  Genalyte's Rapid COVID-19 Antibody Test Obtains EUA

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

  PR Newswire 10.16.20
  

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• 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
  

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• 

  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
  

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• 

  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
  

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• 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
  

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• 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
  

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• 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
  

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• 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
  

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• Diagnostics
  

  Luminex Gains EUA for COVID-19 Antibody Test

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

  PR Newswire 07.20.20
  

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• 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
  

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• 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
  

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• 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
  

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• Diagnostics
  

  Virality Diagnostics Gains EUA for Rapid COVID-19 Antibody Test

  Delivers easily interpreted results within 15 minutes.

  PR Newswire 06.26.20
  

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• 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
  

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• 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
  

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• 

  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
  

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• 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
  

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• 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
  

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• 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
  

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• 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
  

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• 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
  

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• 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
  

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• 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
  

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• 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
  

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• 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
  

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• 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
  

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• 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
  

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• 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
  

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• 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
  

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• 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
  

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• Diagnostics
  

  Quest Diagnostics Launches Consumer-Initiated COVID-19 Antibody Test

  Individuals can purchase the test online through QuestDirect.

  PRNewswire 04.28.20
  

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• Diagnostics
  

  LabCorp COVID-19 Antibody Tests Become Available Nationwide

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

  LabCorp 04.28.20
  

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• 

  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
  

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• 

  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
  

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• 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
  

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• 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
  

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• 

  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
  

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• 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
  

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