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Biodesix SARS-CoV-2 Droplet Digital™ PCR (ddPCR™) Test

Frequently Asked Questions

When will the test be available?
The test was made available to certain healthcare systems in Colorado on April 6, 2020.

What is corona virus?
Coronavirus is a large family of viruses that cause colds and other upper respiratory infections. The current coronavirus outbreak is known as COVID-19, an abbreviated name for “coronavirus disease 2019.” It was first identified in China in December 2019 and has since spread to countries around the world, including the U.S. For comprehensive information about COVID-19, visit the Centers for Disease Control and Prevention (CDC).

What technology does your test use?
Bio-Rad ddPCR.

How is your test different from other tests that are being used currently?
Recent studies have shown that ddPCR-based testing is more sensitive than qPCR, specifically in the reduction of false negative results.1,2

Who can order your test?
Physicians can only order the test if it is available to their healthcare system.

Who can receive this test?
The decision on who to test is determined by the physician and healthcare system, and they are responsible for collecting the sample from the patient. Biodesix does not collect samples from patients.

How is the sample collected?
The sample is collected via a swab of the nose and throat by each patient’s healthcare provider. This sample is sent in a sterile kit to the Biodesix Laboratory to be processed.

How many tests can your lab process?
Biodesix’s current test capacity is 1000 specimen per day. Biodesix plans to scale capacity as the need arises.

When can I expect to see results?
Results should be available in less than 72 hours.

How can my hospital get this test? What are the steps to get on the waiting list?
Please contact covidtesting@biodesix.com for more information.

What is the price of the test?
Medicare has set the rate for non-CDC developed tests at approximately $100. Congress recently passed the Families First Coronavirus Response Act which ensures that patients will not have any copay, coinsurance, or deductible for the testing. 

How can you test samples before you’ve received the FDA EUA designation?
In light of the increasing number of COVID-19 cases throughout the country and the urgent need to expand the country’s COVID-19 diagnostic testing capacity, the FDA has allowed testing to begin immediately following successful completion of assay validation and FDA notification. For more information, please visit the FDA's website: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. This policy enabled Biodesix to start testing on April 6, 2020. The FDA recommends that laboratories submit a completed EUA request within 15 business days of the initial communication to FDA that the assay has been successfully validated. Biodesix has exceeded this timeline by submitting the EUA on April 8, 2020, only two business days after successful validation and FDA notification.

 

References

  1. Suo, T et al. ddPCR: a more sensitive and accurate tool for SARS-CoV-2 detection in low viral load specimens. medRxiv (preprint). https://doi.org/10.1101/2020.02.29.20029439
  2. Dong, I et al. Highly accurate and sensitive diagnostic detection of SARS-CoV-2 by digital PCR. medRxiv (preprint). https://doi.org/10.1101/2020.03.14.20036129

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