Ginkgo Bioworks, Inc. (“Ginkgo”) has engaged Infinity BiologiX LLC (“IBX”) to allow us to provide access to The Infinity BiologiX TaqPath SARS-CoV-2 Assay (the “IBX Test”) performed in the Infinity BiologiX Genomics Laboratory, a CLIA-certified high complexity laboratory.
The version of the IBX Test offered by Concentric by Ginkgo is a saliva-based test.
The IBX Test being offered by Concentric by Ginkgo is a PCR (polymerase chain reaction)-based test that is designed to detect the virus that causes COVID-19 in respiratory specimens, for example nasal, oral swabs, or saliva.
A PCR (polymerase chain reaction) test checks for genetic material (viral RNA) produced by the virus. This is used to detect the presence of the virus that causes COVID-19.
No. This test is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this test is supported by the Secretary of Health and Human Services (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19.
This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration that circumstances exist justifying emergency use of In Vitro Diagnostics (IVDs) for the detection and/or diagnosis of COVID-19, unless it is sooner terminated or revoked (after which the test may no longer be used).
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.
The IBX Test is a viral test. The CDC recommends viral tests to diagnose infection with COVID-19. Unlike viral detection methods that can detect currently infected persons, antibody tests help determine whether the individual being tested was previously infected, even if that person never showed symptoms. Antibody tests for COVID-19 can play an important role in surveillance and epidemiologic studies, which can provide insights into the transmission dynamic of the virus among the general population. The CDC recommends getting viral tests in certain situations. To learn more, visit: https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html
The CDC indicates (as of September 18, 2020) that a healthcare provider may determine that you should get tested based on a number of considerations, including:
Prior to testing, authorization from a physician is required. This process is enabled by our platform.
After an organization enrolls, its members are invited to sign in to our portal and fill out a health questionnaire. Healthcare providers are provided by PWNHealth, who will evaluate your questionnaire responses and determine who is eligible for testing. PWNHealth is an independent healthcare provider network that provides oversight services and has partnered with Concentric’s platform providers, ixLayer and One Codex.
Eligible individuals can then proceed to the designated Test Center at a specified time in order to collect their sample.
Samples are shipped to our partner laboratory at Infinity BiologiX Clinical Genomics Laboratory, and results are communicated back to the individuals and organizations through our portals powered by ixLayer and One Codex (who provides this portal in compliance with all applicable privacy laws and individual authorization).
A PCR test can be used to detect the virus that causes COVID-19 on the day of sample collection. If your results are positive, it is important to limit your exposure to other people and continue to monitor your symptoms. If your results are negative, the test did not detect the presence of the virus that causes COVID-19 in the sample you provided.
For more information on positive and negative results associated with the IBX Test, please see the patient fact sheet.
After receiving your results, you will have an opportunity to speak with a licensed physician from our healthcare provider network partner, PWNHealth, who can answer any questions you may have about your test results and help determine next steps in care.
Depending on your test results, PWNHealth’s Care Coordination Team may attempt to contact you to notify you of your results and schedule a telehealth consult with a physician or other healthcare provider.
Depending on your test results, PWNHealth’s Care Coordination Team may attempt to contact you to notify you of your results and schedule a telehealth consult with a physician or other healthcare provider.
You should NOT eat, drink, smoke, or chew gum for 30 minutes before giving your saliva sample.
You do not need to do anything to prepare for the test. You do not need to fast or stop taking any medications before testing. Further instructions will be provided to you at the lab or in your test kit.
Potential risks include:
Potential benefits include:
We encourage you to consult our FAQ or contact us at support@concentricbyginkgo.com.
Testing is available for children 4 years of age and older. If your child has new or worsening emergency warning signs, such as trouble breathing, persistent pain or pressure in your chest, new confusion, inability to wake or stay awake, bluish lips or face, or any other symptoms that are severe or concerning to you, call 911 or seek emergency medical attention instead of ordering this test.
A healthcare provider may provide an order for a COVID-19 viral test so that your child may be tested for detection of the virus that causes COVID-19 if the healthcare provider suspects your child to have COVID-19. A healthcare provider may determine that your child should get tested based on a number of reasons and considerations, including if:
If you have any other questions, we recommend that you speak with your child’s primary healthcare provider about testing recommendations to see if testing is right for your child at this time.
The IBX Test is not currently approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this test is supported by the Secretary of Health and Human Services (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. The EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of In Vitro Diagnostics (IVDs) for the detection and/or diagnosis of COVID-19, unless the EUA is terminated or revoked by FDA (after which the test may no longer be used).
This test has been authorized by the 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.
A PCR (polymerase chain reaction) test checks for genetic material (viral RNA) produced by the virus. This is used to detect the presence of the virus that causes COVID-19.
Ginkgo Bioworks, Inc. (“Ginkgo”) has engaged Infinity BiologiX LLC(“IBX”) to allow us to provide access to The Infinity BiologiX TaqPath SARS-CoV-2 Assay (the “IBX Test”) performed in the Infinity BiologiX Clinical Genomics Laboratory, a CLIA-certified high complexity laboratory.
COVID-19 is caused by the SARS-CoV-2 virus. The virus, which can cause mild to severe respiratory illness, was first identified in Wuhan, China, and has now spread globally, including the United States. There is limited information available to characterize the spectrum of clinical illness associated with COVID-19 but it likely spreads to others when a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.).
If you have a positive test result, it is very likely that you have COVID-19. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (a false-positive result). Your healthcare provider will work with you to determine how best to care for you based on the test results along with medical history, and your symptoms.
In the case of a positive result, a licensed physician from PWN Health’s Team will contact you to provide clinical guidance on the meaning of those results.
A negative test result means that the virus that causes COVID-19 was not found in your sample. For COVID-19, a negative test result for a sample collected while a person has symptoms usually means that COVID-19 did not cause your recent illness.
However, it is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. If this is the case, your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you.
It is important that you work with your healthcare provider to help you understand the next steps you should take.
We recommend that you consult the Coronavirus (COVID-19) Isolation/ Quarantine information PDF provided by PWNHealth.
PWNHealth is an independent healthcare provider network that provides oversight services to you in connection with the laboratory testing that you have requested. PWNHealth and its services are independent from the laboratory and company from whom you requested and registered for a test and their services.
You should NOT eat, drink, smoke, or chew gum for 30 minutes before giving your saliva sample. You do not need to do anything to prepare for the test. You do not need to fast or stop taking any medications before testing. Further instructions will be provided to you at the lab or in your test kit.
The IBX Test is authorized for use across 50 states in the United States.