Coronavirus Disease (COVID-19) News and Information for Healthcare Providers & Patients

Gene by Gene’s Response To COVID-19

Gene by Gene understands the extreme importance of increasing the nation’s access to COVID-19 testing to combat the spread of the novel coronavirus in our communities.  In response to this public health crisis, we are working around the clock to help meet the critical demand for testing.

Patients who have COVID-19 symptoms should consult a physician or other healthcare provider. Only a healthcare provider can collect the specimen necessary to test for COVID-19. Patients suspected of having COVID-19 MUST NOT ENTER Gene by Gene’s place of business.

Gene by Gene is currently accepting orders for COVID-19 testing from approved healthcare providers. If you are interested in partnering with Gene by Gene, please contact us by submitting an inquiry or emailing us at covid19@genebygene.com

We will continue to add instrumentation and work with our vendors to procure supplies as our ability to expand our capacity depends on the availability of these supplies. We will continue to update this page with the most up-to-date testing information.

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Additional Statements About COVID-19 Tests

  • This test has not been FDA cleared or approved;
  • This test has been authorized by FDA under an EUA for use by authorized laboratories;
  • This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked.