Quest Diagnostics : Media Statement about COVID-19 Testing

Posted April 6, 2020 Noon EDT

Quest Diagnostics Has Performed and Reported Results of Nearly 550,000 COVID-19 Tests, Backlog Drops by Half from Peak to Equivalent of 2-3 Days of Testing

Quest Diagnostics has performed and reported results of nearly 550,000 COVID-19 tests to providers and patients across the United States. We continue to provide testing from 12 laboratories. Through these laboratories, we are now able to perform more than 35,000 COVID-19 tests a day.

Backlog

In addition, we have reduced our backlog significantly. Our backlog is now approximately 80,000 COVID-19 tests, a 50 percent decline compared to our backlog of approximately 160,000 tests as of March 25. The backlog of 80,000 days corresponds to approximately 2-3 days of testing.

Turnaround times

Our turnaround time for specimens of patients forwarded to Quest Diagnostics through our patient prioritization program is now one day on average. Through this program, we prioritize specimens marked by health systems as Priority 1 patients under CDC guidance (symptomatic ill hospital patients and healthcare workers). For all other patients, the average turnaround time is 2-3 days from time of specimen pickup. However, patients in certain hot spot areas, including the NY-NJ metropolitan area, Chicago and Miami, may experience turnaround times of 3 or more days due to significant demand for services.

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Posted April 1, 2020 8:40 PM EDT

Quest Diagnostics Performed and Reported Results of More Than 400,000 COVID-19 Tests Since Introducing COVID-19 Testing on March 9, Reports Progress on Reduced Backlogs

From March 9 to April 1, Quest Diagnostics has performed and reported results of more than 400,000 COVID-19 tests to providers and patients across the United States.

We introduced COVID-19 testing on March 9 from a single laboratory, in San Juan Capistrano, California. In approximately the first two weeks of providing testing, we experienced a sharp influx of test orders that continued to outpace our growing capacity through March. We also incurred a backlog across our network that has been particularly acute at our San Juan Capistrano, Calif. laboratory, given it was the first and, for several days, only lab in our network to provide COVID-19 testing. Much of this testing was based on our lab-developed test, which is less suited to high throughput environments.

In mid-to-late March, we implemented a higher throughput in vitro diagnostic test for COVID-19 from Roche at a total of 12 Quest Diagnostics laboratories across the United States. We also implemented our lab-developed test at two additional laboratories. We completed this process by the end of March.

We exited March with testing capacity in excess of 30,000 COVID-19 tests a day across the 12 performing laboratories.

We grew our testing capacity to a level that allowed us to meet and at times exceed demand. As a result, we reduced the backlog 28% from 160,000 tests on March 25 to 115,000 tests currently.

Turnaround Times

Our average turnaround time to report results from time of specimen pickup continues to be 4-5 days on average, same as during the last week of March (See Media statement dated March 24). In addition, our patient prioritization program is speeding turnaround time even further for the patients most in need. Through this program, we ask health systems to prioritize patients for testing, in alignment with the CDC's test prioritization protocol with emphasis on 'Priority 1' Patients. Turnaround time for specimens of patients forwarded to Quest Diagnostics through this program is 2-3 days on average from time of specimen pickup and, for some patients, may be less than a day. We appreciate the collaboration of the many health systems we service across the United States to direct testing to patients who are most in need at this critical time.

We appreciate the frustration of waiting for a test result, and our laboratories are performing COVID-19 tests 24/7 to provide testing as quickly as possible. While we are more confident now in our ability to meet demand and report results for COVID-19 testing than in mid-March, when we were still ramping up capacity, this crisis is fluid and unpredictable, and so is the demand for COVID-19 testing. Future changes in demand for COVID-19 testing could alter our ability to provide testing and report results.

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Posted March 24, 2020 5:30 PM EDT

Quest Diagnostics further expands COVID-19 testing capacity: Expected to rise to 30,000 a day by end of the week

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.

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Posted March 19, 2020, 10:30 AM EDT

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.

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Posted March 14, 2020 1:30 PM EDT

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.