Outsourcing Directory

EnMed MicroAnalytics





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    Related Content

    • Thermo Fisher Scientific Launches Updated COVID-19 Test

      Thermo Fisher Scientific Launches Updated COVID-19 Test

      Updated version of highly sensitive and accurate COVID-19 PCR kit accounts for known and future viral mutations.
      PR Newswire 09.10.21

    • Diagnostics
      FDA Issues EUA for BD Veritor At-Home Covid-19 Test

      FDA Issues EUA for BD Veritor At-Home Covid-19 Test

      The test does not require a prescription, a laboratory or a long wait for results.
      BD 08.26.21

    • Diagnostics
      Hologic Gains CE Mark for Saliva Samples with COVID-19 Test

      Hologic Gains CE Mark for Saliva Samples with COVID-19 Test

      Hologic has shipped over 100 million Aptima COVID-19 tests globally since spring 2020.
      Business Wire 07.14.21


    • Quidel Granted EUA to Market COVID-19 Antigen Test

      Quidel Granted EUA to Market COVID-19 Antigen Test

      Assay provides results in 15 minutes and s now available without a prescription.
      Michael Barbella, Managing Editor 05.17.21

    • QIAGEN Granted EUA for its 4-Plex COVID-19 Test

      QIAGEN Granted EUA for its 4-Plex COVID-19 Test

      The assay can detect and differentiate influenzas A and B, respiratory syncytial virus (RSV), and COVID-19 infections within 80 minutes.
      Michael Barbella, Managing Editor 05.06.21

    • Diagnostics
       BD Gains EUA for Asymptomatic COVID-19 Screening via Rapid Testing

      BD Gains EUA for Asymptomatic COVID-19 Screening via Rapid Testing

      BD Veritor Plus System supports return-to-school and return-to-work programs through serial testing.
      Sam Brusco, Associate Editor 04.01.21


    • Diagnostics
      Abbott

      Abbott's Rapid COVID-19 Self-Test Receives EUA

      Permits asymptomatic, non-prescription, over-the-counter self-use for people with or without symptoms.
      Sam Brusco, Associate Editor 04.01.21

    • Diagnostics
      FDA Issues EUA to First OTC Home Molecular COVID-19 Test

      FDA Issues EUA to First OTC Home Molecular COVID-19 Test

      Results from the Cue COVID-19 test are sent directly to a companion app in about 20 minutes.
      Sam Brusco, Associate Editor 03.08.21

    • Diagnostics
      Quidel

      Quidel's QuickVue At-Home COVID-19 Test Earns EUA

      Easy-to-use at-home test provides results in ten minutes with a doctor’s prescription.
      Sam Brusco, Associate Editor 03.02.21


    • Quidel Opens New Manufacturing Facility to Boost COVID-19 Antigen Test Production

      Quidel Opens New Manufacturing Facility to Boost COVID-19 Antigen Test Production

      New plant aims to reach a run rate of 600 million QuickVue tests per year by the end of 2021.
      Michael Barbella, Managing Editor 02.18.21

    • Diagnostics
      Suitcase Laboratory to Detect COVID-19 in Development

      Suitcase Laboratory to Detect COVID-19 in Development

      Mobile laboratory for rapid detection of SARS-CoV-2 for Africa.
      Sam Brusco, Associate Editor 02.12.21

    • Contract Manufacturing
      Use Vertical Integration to Increase Productivity, Drive Innovation

      Use Vertical Integration to Increase Productivity, Drive Innovation

      The concept of vertical integration is simple: a company combining two or more stages of production that would normally be operated by separate companies.
      Ryan Lipe, Senior Vice President of Sales & Marketing, MGS 02.03.21


    • At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities

      At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities

      Public health officials need to stress the importance of mass testing and contact tracing even with several vaccines approved.
      Michael Barbella, Managing Editor 01.25.21

    • Diagnostics
      EKF Introduces Accurate Quantitative COVID-19 Antibody Test Kit

      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

    • FOREFRONT MEDICAL TECHNOLOGY ANNOUNCES UNIQUELY-DESIGNED COVID-19 TEST SWAB

    • Diagnostics
      FDA Authorizes Abbott

      FDA Authorizes Abbott's Rapid, $25 COVID-19 Test for At-Home Use

      Telehealth service will take users step-by-step through the sample collection process.
      U.S. Food and Drug Administration 12.17.20

    • Diagnostics
      FDA Authorizes First OTC Fully At-Home Diagnostic COVID-19 Test

      FDA Authorizes First OTC Fully At-Home Diagnostic COVID-19 Test

      The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test.
      U.S. Food and Drug Administration 12.16.20

    • Diagnostics
      CRISPR-Based COVID-19 Test Uses Smartphone Camera

      CRISPR-Based COVID-19 Test Uses Smartphone Camera

      The rapid, one-step mobile test could help combat the pandemic and fully reopen communities.
      PR Newswire 12.07.20

    • Diagnostics
      QIAGEN Launches Portable Digital SARS-CoV-2 Antigen Test

      QIAGEN Launches Portable Digital SARS-CoV-2 Antigen Test

      Can accurately analyze over 30 samples per hour.
      Business Wire 11.12.20

    • The Lost Year: 2020 Year in Review

      The Lost Year: 2020 Year in Review

      Lessons learned from the global coronavirus pandemic.
      Michael Barbella, Managing Editor 11.04.20

    • Diagnostics
       How COVID-19 is Reshaping the Diagnostics Testing Sector

      How COVID-19 is Reshaping the Diagnostics Testing Sector

      The short-term impact on the diagnostics sector is readily apparent as the pandemic has fueled overwhelming demand for effective SARS-CoV-2 testing solutions.
      Eric Williams, Managing Director, Capstone Headwaters 11.04.20

    • Diagnostics
      Examining the COVID-19 Detection Kits Market

      Examining the COVID-19 Detection Kits Market

      RT-PCR has become second to none in the global healthcare systems for testing COVID-19.
      Sunil Jha, Research Content Developer, Global Market Insights 10.16.20

    • Diagnostics
      Abbott Shares ID NOW COVID-19 Interim Clinical Study Results

      Abbott Shares ID NOW COVID-19 Interim Clinical Study Results

      ID NOW performance of 95 percent sensitivity, 97.9 percent specificity within seven days of symptom onset.
      Abbott Laboratories 10.07.20

    • Diagnostics
      FDA Expands Authorization of Hologic Aptima COVID-19 Test

      FDA Expands Authorization of Hologic Aptima COVID-19 Test

      Now authorized for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.
      Business Wire 10.07.20

    • Diagnostics
      UK Study Reveals the Accuracy of a 90-Minute COVID-19 Test

      UK Study Reveals the Accuracy of a 90-Minute COVID-19 Test

      Lab-in-Cartridge rapid testing device shown to have over 94% sensitivity and 100% specificity.
      Imperial College London 09.18.20

    • Diagnostics
      DetectaChem Gains EUA for Mobile COVID-19 Test Kit

      DetectaChem Gains EUA for Mobile COVID-19 Test Kit

      Portable lab-grade diagnostic technology can run up to 96 tests per device in just 30 minutes.
      PR Newswire 09.04.20

    • Diagnostics
      Feds to Buy $760M of Abbott

      Feds to Buy $760M of Abbott's $5, 15-Minute COVID-19 Test

      150 million tests, which require no lab equipment, will be strategically distributed to where they’re needed most.
      HHS.gov U.S. Department of Health & Human Services 08.28.20

    • Diagnostics
      Guardant Health

      Guardant Health's Next Generation Sequencing-Based COVID-19 Test Earns EUA

      Helps with reopening at Delaware State University.
      GlobeNewswire 08.24.20

    • Diagnostics
      Hologic Launches Validated COVID-19 Test Pooling Protocol

      Hologic Launches Validated COVID-19 Test Pooling Protocol

      Helps labs deliver greater quantities of highly accurate test results, reduce turnaround times.
      Business Wire 08.11.20

    • Diagnostics
      FDA Authorizes First COVID-19 Test to Screen Asymptomatic People

      FDA Authorizes First COVID-19 Test to Screen Asymptomatic People

      LabCorp COVID-19 RT-PCR Test EUA reissued for asymptomatic cases, test pooling.
      U.S. Food and Drug Administration 07.27.20

    • Diagnostics
      Quest Nabs EUA for First COVID-19 Test Pooling

      Quest Nabs EUA for First COVID-19 Test Pooling

      EUAs also granted for use of self-collection molecular diagnostic kit on the Hologic and Roche platforms.
      PR Newswire 07.20.20

    • Diagnostics
      Third Combo Flu/COVID-19 Test Earns EUA

      Third Combo Flu/COVID-19 Test Earns EUA

      FDA has previously issued EUAs to BioFire Diagnostics and QIAGEN.
      U.S. Food and Drug Administration 07.06.20

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

      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

    • FDA Warns of Unauthorized Fraudulent COVID-19 Test Kits

      FDA Warns of Unauthorized Fraudulent COVID-19 Test Kits

      FDA has not yet authorized any test available to purchase for testing yourself at home for COVID-19.
      U.S. Food and Drug Administration 03.23.20