Quest Diagnostics : Media Statement about COVID-19 Testing

Posted March 14, 2020 1:30 pm ET

For more information, members of the media may contact us at: [e-mail]

On March 9, 2020, Quest Diagnostics introduced a new lab-developed test for COVID-19*. Health care providers anywhere in the U.S. are now able to order this new test from Quest. This molecular test detects nucleic acid of the virus that causes COVID-19 in respiratory specimens.

Quest Diagnostics currently performs its COVID-19 lab-developed test at our Quest Diagnostics Infectious Disease laboratory in San Juan Capistrano (SJC), California.

COVID-19 is a rapidly evolving situation. Here's what we are doing:

• Quest is working with other labs through our trade association, the American Clinical Laboratory Association (ACLA), to rapidly expand capacity across the country. As ACLA estimates in a media statement issued March 13, 2020, 'once additional FDA-approved high-throughput testing is available on large diagnostic platforms next week, the industry expects its capacity to be increased to more than 20,000 tests per day. Assuming there are no delays or shortages of necessary materials and supplies, commercial capacity is expected to exceed 280,000 tests per week by April 1.'
• We are rapidly expanding testing capacity, bringing up our new lab-developed test in our high-complexity laboratories in Chantilly, VA and Marlborough, MA the week of March 16, 2020.
• With an FDA-approved high-throughput test now available, we also expect to significantly expand testing at several regional Quest Diagnostics laboratories by the end of March. These additional laboratories are located in major cities, including Dallas; Teterboro, NJ; Miami; Los Angeles; Chicago; Kansas City; Pittsburgh; and Phoenix. Plus, the roll out of these tests in major cities means patients will have closer access to testing
• With these two labs and our lab in California performing our COVID-19 lab-developed test and with testing with an IVD test kit, we expect to have capacity toperform approximately 10,000 tests a day by the end of next week and approximately 20,000 tests a day by the end of the month.

About the Quest Diagnostics Lab-Developed Test

The Quest Diagnostics lab-developed test detects nucleic acid in respiratory specimens of patients meeting the clinical criteria of the U.S. Centers for Disease Control and Prevention (CDC) for COVID-19 testing.  The test is performed on respiratory specimens collected by healthcare providers and forwarded to Quest Diagnostics. We report results of our COVID-19 testing to public health labs, consistent with guidelines.

Providers should not refer any patient suspected of (persons under investigation) or confirmed to be infected with COVID-19 to a Quest Diagnostics Patient Service Center or other phlebotomy site. We appreciate the efforts of the media to educate the public that we are not accepting individuals suspected or confirmed to have COVID-19 at these locations.

Healthcare providers should visit our dedicated site for more information.

*The test has not been FDA cleared or approved or authorized. The test has been validated according to CLIA (Clinical Laboratory Improvement Amendments), but FDA's independent review of this validation is pending.