Quest Diagnostics Media Statement about COVID-19 Testing
This is an evolving situation. Please check back to this page periodically for the latest information.

Quest Diagnostics further expands COVID-19 testing capacity

Current capacity is 25,000 COVID-19 tests a day, expected to rise to 30,000 a day by end of the week

Posted March 24, 2020 5:30 PM EST

Quest Diagnostics has expanded its COVID-19 testing capacity to 25,000 tests per day, significantly higher than initially forecast. In addition, Quest now expects to further expand capacity to 30,000 COVID-19 tests per day by the end of this week.

As of March 9, when Quest Diagnostics introduced COVID-19 testing, and the end of the day March 23, the company has performed and reported results for 106,000 COVID-19 tests. About 24,000 of these were performed and reported March 23.  

Performing Laboratories

Quest is now performing COVID-19 testing at 12 laboratories in its national network. Three of these laboratories perform both the company’s lab-developed Quest SARS-CoV-2 rRT-PCR test (which was granted FDA emergency use authorization on March 17) and the highly automated Roche cobas® SARS-CoV-2 Test. These labs are in San Juan Capistrano, Calif., Chantilly, VA and Marlborough, Mass.

The other Quest Diagnostics laboratories are performing the highly-automated Roche cobas® SARS-CoV-2 Test are in Dallas, TX; Lenexa, KS; Lewisville, TX; Miami, FL; Phoenix, AZ; Pittsburgh, PA;  Teterboro, NJ; West Hills, CA; and  Wood Dale, IL.

The expansion to the highly-automated in vitro diagnostic (IVD) platform follows Roche’s announcement on March 13 that the FDA has issued an emergency use authorization for the test. IVD tests are generally more automated and better suited to high-throughput testing than lab-developed tests.

Capacity

Quest is expanding capacity faster than initially forecast. On March 14, we communicated in our media statement that we anticipate we will have the capacity to perform 10,000 tests a day by the end of this week and 20,000 a day by the end of the month. As of March 23, we have expanded our COVID-19 testing capacity to 25,000 tests per day and expect to further expand capacity to 30,000 tests per day by the end of the week.

Turnaround Time and Prioritization Program

Our current turnaround time is on average 4-5 days, from time of specimen pickup. In some cases, the time to report results may be shorter or longer, depending on demand. However, the experience of providers and patients can vary across the United States. In some cases, results may not be provided for about a week from specimen pickup; in others, results may be returned within a day or two.

Although we are rapidly expanding testing capacity, demand for the testing is growing faster, and we cannot accommodate everyone who wants testing and meet tight turnaround time expectations.

To help address this issue, we are working with healthcare systems to prioritize testing for in-hospital patients and symptomatic hospital healthcare workers. Hospitals and healthcare systems can submit specimens from these patients to us with a “high priority” designation. As a result, these specimens will be expedited within our standard first in, first out testing process. We are already notifying health systems of ways to submit specimens under these conditions.

Global Supply

Supply for COVID testing and care is a global industry- and government-wide issue. Quest Diagnostics is in constant contact with our suppliers as well as industry and government leaders to address this global supply issue in order to provide as much access to COVID-19 testing as possible.

Patient Service Centers: Our Peace of Mind Program for At-Risk Patients

COVID-19 testing is based on respiratory specimens collected by healthcare providers in their offices or other healthcare settings. 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 our patient service centers or other phlebotomy sites. Healthcare providers should visit our dedicated COVID-19 Provider site for more information.

On March 21, 2020, we launched our “Peace of Mind” program to give individuals at higher risk of adverse outcomes due to COVID-19 special access to our 2,250 patient service centers across the United States.


B-Roll and Photos: https://app.box.com/s/djpwi9bt8bwnaptdvvvtxkgotszvw0hp

 

Posted March 19, 2020, 10:30 AM EST

FDA issues emergency use authorization for company’s Quest SARS-CoV-2 rRT-PCR test

On March 17, 2020, Quest Diagnostics received emergency use authorization for its SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR (“Quest SARS-CoV-2 rRT-PCR”) test for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens from individuals suspected of COVID-19 by their healthcare provider.  (Healthcare providers should visit our dedicated COVID-19 Provider site for more information about this test.)

Under FDA guidance issued on February 29, 2020, Quest Diagnostics has been performing this test at our high complexity laboratory in San Juan Capistrano, Calif. since March 9, 2020.  The company is now performing this test at its laboratory in Chantilly, VA, and expects to be performing it at its laboratory in Marlborough (aka Marlboro), Mass, by the end of the week.

COVID-19 testing is based on specimens collected by healthcare providers at their offices or other settings. 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 our patient service centers or other phlebotomy sites.

 

Posted March 14, 2020 1:30 PM EST

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 to perform 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.

 

As of March 19, 2020

For further information: Members of the media may contact us at: mediacontact@QuestDiagnostics.com