Biodesix COVID-19 Droplet Digital™ PCR (ddPCR™) Test
Frequently Asked Questions (FAQs)
When will the test be available?
We are committed to moving as quickly as possible to bring this COVID-19 test to the public. Biodesix and Bio-Rad are working to gain the Emergency Use Authorization (EUA) approval from the FDA to allow Biodesix to begin testing in the U.S. immediately following that approval. Biodesix expects the test to be available in early April, 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).
How is your test different from other tests that are being used currently?
In recent data, the test using ddPCR technology was shown to be more accurate than other tests using qPCR in detecting the virus and thereby reducing the concern of false negatives.
The COVID-19 ddPCR testing showed superior sensitivity and precision for clinical detection of SARS-CoV-2 (the virus that causes COVID-19) compared to existing test methods that are performed using qPCR technology. Recent data suggest that the ddPCR testing significantly improves diagnostic detection accuracy of SARS-CoV-2 from 28.2% to 87.4%, thereby reducing false negatives.
How do I get the test?
The test is not yet available, but we are working diligently to bring it to market. Once it is available, it must be ordered from a physician. Biodesix does not collect the tests directly in the laboratory and there are no send out kits that go directly to patients.
How does the company intend on bringing the test to Healthcare providers?
The company is planning to make the test available in phases. Biodesix will initially offer the test to healthcare systems within the state of Colorado.
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.
Do I need a doctor to order it?
Yes, only a physician can order the test if it is available to their healthcare system. The Biodesix Laboratory does not do the sample collection, we only process the tests that are received from healthcare providers.
How many tests can your lab do?
Biodesix expects that our capacity is 1,000 tests per day.
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 Biodesix Customer Care: (866) 432-5930 or by fax at (866) 432-3338.
What is the price of the test?
Medicare has set the rate for non-CDC developed tests at approximately $51. Congress recently passed the Families First Coronavirus Response Act which ensures that patients will not have any copay, coinsurance, or deductible for the testing.