FDA Authorizes Quest Diagnostics COVID-19 Diagnostic Testing for Specimen Pooling for Emergency Use, https://newsroom.questdiagnostics.com/2020-07-18-FDA-Authorizes-Quest-Diagnostics-COVID-19-Diagnostic-Testing-for-Specimen-Pooling-for-Emergency-Use, Demand for COVID-19 molecular diagnostic testing continues to soar, further increasing turnaround times for test results. are the property of their respective owners. This week, we expect to ramp up our capacity to reach 115,000 of these tests a day. Our test capacity outpaces demand and we have no backlog. These common-sense measures can help reduce the spread of COVID-19 and ensure the country’s test capacity is available for those who need it most. Sharon Hospital. We continue to: expand our physical capacity with additional testing equipment and platforms; add capacity through our lab referral partner program; and remain in close contact with our suppliers to acquire the supplies needed to provide testing. Read today’s press release. It does not reflect retrospective analysis of tests that may be outstanding due to past ordering patterns. The test has been validated according to CLIA (Clinical Laboratory Improvement Amendments), but FDA’s independent review of this validation is pending. Quest Diagnostics offers payment plans, which allows patients to pay in monthly installments until their balance is paid in full. The average turnaround time* for our COVID-19 molecular diagnostic testing is 2 days across all populations and 1-2 days for our priority population, which includes hospitalized patients, individuals in long-term care (such as nursing homes), and presurgical patients. We also continue to expand options for individuals to access convenient, quality COVID-19 testing. 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. Quest Diagnostics and the Quest Diagnostics Foundation are founding sponsors of Choose Healthy Life, a sustainable, scalable and transferable approach to address public health disparities through the Black Church. Our average turnaround time* is 2 days across all populations and 1-2 days for our priority population, which includes hospitalized patients, individuals in long-term care (such as nursing homes), and presurgical patients. 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. 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. Quest Diagnostics has expanded its COVID-19 testing capacity to 25,000 tests per day, significantly higher than initially forecast. By continuing to use the site, you confirm your awareness and acceptance of our use of cookies. Over the month of July, we will continue to ramp up our capacity to reach 150,000 molecular diagnostic tests a day. However, the worldwide supply chain for collection kits, reagents, and personal protective equipment (PPE) remains strained. Despite an expected decline in testing overall, both for our company and our industry, during the holiday period, we note that the number of new cases and positivity rates continue on an upward trend.1 We have the capacity to service increased demand now and continue to add capacity to prepare for potential future surges. We are taking several measures to minimize this possibility. 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. The company began the program with a focus on Priority 1 patients the last week of March. © 2000-2021 Quest Our average turnaround time is 1 day for priority patients and 2-3 days for all other populations.*. We are reporting antibody test results in 1-2 days on average. Quest Diagnostics Performs and Reports Results of 1.7 Million COVID-19 Diagnostic Tests and 620,000 Antibody Tests to Date, Quest has performed and reported results of approximately 1.7 million COVID-19 diagnostic tests since we introduced these services on March 9. We also require all patients to wear a face covering before entering. Last week, we also extended our patient prioritization program to include patients that may be considered Priority 1, 2 and 3 under CDC criteria. On April 21, Quest announced that it has begun to perform antibody testing for coronavirus (COVID-19) using blood samples. You will be redirected automatically in 15 seconds or you can click the OK button. Quest is expanding capacity faster than initially forecast. While Quest has the supplies to meet its current capacity targets, the supply chain globally continues to be under strain. We are reporting our diagnostic test results in 1-2 days on average.*. Pay your bill online. In recent weeks, we have extended our outreach to providers, including federally qualified healthcare clinics (FQHCs) that focus on underserved populations. We now have ample capacity to accommodate incoming orders. As COVID-19 Cases Surge in the U.S., Quest Diagnostics Increases Capacity to 215,000 COVID-19 Molecular Diagnostic Tests a Day, Continues to Provide 2-Day Average Turnaround Time. By continuing to use the site, you confirm your awareness and acceptance of our use of cookies. *Turnaround time includes the time to transport a specimen to a Quest Diagnostics laboratory after collecting it at a patient service center or provider site to reporting results. As a result, our average turnaround time* for all patients is now down to 2-3 days for incoming specimens. To address these challenges we are seeking to add new technology platforms, among other options. Quest Introduces New COVID-19 IgM-IgG Antibody Test Option. Since we introduced these services on April 21, Quest has performed and reported results of more than 2.10 million COVID-19 antibody tests. We continue to expect to scale up capacity to provide 185,000 tests a day by Labor Day, with further gains possible. While the increase is modest, assuming national trends continue, we expect COVID-19 cases and corresponding orders for testing to increase for the foreseeable future, which may cause turnaround times to grow. Turnaround time includes the time to transport a specimen after collecting it at a provider site to reporting results. We are also taking steps to add capacity, such as through the addition of new testing platforms as well as relationships with our laboratory referral partners. For more information or to opt out of the use of cookies. Since June 29, demand has continued to rise nationwide, particularly in the South, Southwest and West regions of the country, outpacing our capacity. Quest Diagnostics Performs and Reports Results of Approximately 3.15 Million COVID-19 Diagnostic Tests and Approximately 1.50 Million Antibody Tests to Date, Quest has performed and reported results of approximately 3.15 million COVID-19 molecular diagnostic tests. Despite that dramatic increase, demand for testing is increasing even faster. Plans to double molecular diagnostic testing capacity to 100,000 tests a day in June amid expectations of growing demand, Expands antibody test capacity with addition of Ortho Clinical Diagnostics IgG Antibody Test, Provides results in 1-2 days on average for both diagnostic and antibody tests, Facilitates same- or next-day day visits for antibody tests when scheduled in advance at Quest Diagnostics patient service centers, Joins CDC-led SPHERES consortium to coordinate COVID-19 genetic sequencing, Diagnostic Testing: Capacity at 50,000 diagnostic COVID-19 tests per day and turnaround times of 1-2 days on average, Antibody Testing: Capacity at more than 150,000 antibody COVID-19 tests per day and turnaround time of 1-2 days on average, Raises capacity to up to 50,000 diagnostic COVID-19 tests per day, Reports that capacity significantly outpaces demand, with no backlog for a week, Provides results in 1 day for priority patients, less than 2 days for all other patients, Provides results in less than 1 day for priority patients, less than 2 days on average for other populations, Extends Patient Prioritization Program to new populations defined by CDC, Quest is working with other labs through our trade association, the. 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. These include implementing specimen pooling at our laboratories in Chantilly, VA, and Marlborough, Mass. Please check back to this page periodically for the latest information. Despite record demand, our average turnaround time continues to be 1 day for priority 1 patients* and 2-3 days for all other populations. (“All other patients” are typically individuals not marked by the provider as belonging to one of the priority groups per the CDC criteria.) As we approach Thanksgiving, we want to recognize and thank our Quest Diagnostics colleagues for everything they are doing to expand COVID-19 testing for patients across the United States. 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. All rights reserved. We greatly appreciate their commitment to helping patients receive testing services for COVID-19 and many other critical medical conditions. Quest has expanded its patient prioritization program to include Priority 2 and 3 patients as defined by the Centers for Disease Control and Prevention (CDC). In addition, we are working with our providers to prioritize patients as a way to modulate incoming specimens for COVID-19 molecular diagnostic testing. We are taking several steps to address these dynamics. In an analysis released today, researchers at Quest Diagnostics found that rates of positivity for methamphetamine, cocaine, marijuana and other drugs increased in 2019 among individuals tested in connection with workplace drug screening. In recent weeks, we have extended our outreach to healthcare providers such as Federally Qualified Health Centers (FQHCs) and nursing homes, among other organizations. We provide this information to allow the public to make informed decisions about where to obtain testing, before they order a test, should they find our times are too long. COVID-19 Antibody Testing and Plasma Donation. Demand for our molecular diagnostic testing remains high as the virus has spread across much of the United States, particularly the South, Southwest and West. Much of this testing was based on our lab-developed test, which is less suited to high throughput environments. It does not reflect retrospective analysis of tests that may be outstanding due to past ordering patterns. We expect to have capacity to perform approximately 100,000 of these tests a day in early June and approximately 150,000 tests a day by the end of June. Evexia Diagnostics provides access to a network of over 6,000 carefully selected mobile phlebotomists, covering almost every major city in the U.S. We currently have the capacity to perform as many as 135,000 molecular diagnostic tests a day and are working to increase that to 150,000 tests a day by next week. 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 believe these dynamics affect not only Quest Diagnostics but the entire laboratory industry. The only way that we as a country can flatten the curve is if each of us takes personal responsibility – by washing hands often, avoiding people who are sick, staying six feet away from others and wearing a mask in public. These services primarily employ a test platform from Abbott that received FDA emergency use authorization on April 26. Our average turnaround time** for COVID-19 molecular diagnostic testing is approximately 2 days across all populations, including our priority population of hospitalized patients, individuals in long-term care (such as nursing homes), and presurgical patients. Quest has performed and reported results of approximately 1.30 million COVID-19 antibody tests. The test is performed on respiratory specimens collected by healthcare providers and forwarded to Quest Diagnostics. Since introducing COVID-19 testing in the United States on March 9, Quest Diagnostics has performed and reported results of approximately 5.30 million COVID-19 molecular diagnostic tests. We now have the capacity to perform approximately 200,000 antibody tests a day or 1.40 million a week. Over the last three weeks, we’ve seen a steady increase in demand and positivity rates, consistent with national trends. The test received FDA emergency use authorization (EUA) on April 24 and has reported specificity of 100%, which helps prevent false positives. We want to recognize and thank our Quest Diagnostics colleagues for everything they have been doing to expand COVID-19 testing to patients across the United States. Turnaround time can fluctuate with demand and vary by region. As a result, the company has implemented the following workforce actions: In addition, considering the impact of the COVID-19 pandemic on the company’s operations and the important role the company is playing in responding to the COVID-19 pandemic, on June 19, 2020 the Compensation Committee of Quest’s Board of Directors approved an enhancement to the company’s Annual Incentive Plan that makes all employees eligible to receive annual incentive compensation for 2020 based on additional 2020 performance goals related to the company’s COVID-19 pandemic response plan. At Quest Diagnostics, we are doing everything we can to bring more COVID-19 molecular diagnostic testing to patients at this critical time. In addition, Quest now expects to further expand capacity to 30,000 COVID-19 tests per day by the end of this week. Specimen pooling will allow us to optimize capacity, particularly in populations with low rates of COVID-19 disease. Continued efforts to expand test capacity.