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ACLA Update on PCR Testing Capacity For COVID-19
WASHINGTON, D.C. – As COVID-19 cases continue to surge across the United States, ACLA President Julie Khani issued the following statement:
“Yesterday, ACLA member laboratories collectively performed 495,000 COVID-19 PCR tests, reflecting an all-time daily high for our members. We continue to do all that we can to expand testing capacity and provide test results to patients, health care providers and public health agencies as quickly as possible. With demand for testing surging across the country, ACLA member laboratories are experiencing a significant increase in the volume of COVID-19 test orders. Clinical labs are also facing delays or cancellations on orders for critical supplies, such as pipette tips. In addition, specimen pooling, one of the many techniques labs have developed to more efficiently use supplies and increase capacity, is only applicable for populations at low risk or with low prevalence of infection, and is therefore currently limited due to increased positivity rates in communities across the country.
The surge in demand for testing will mean that some members could reach or exceed their current testing capacities in the coming days. In cases where the number of specimens received exceeds an individual laboratory’s testing capacity, there could be an increase in their average time to deliver results.
As we near the upcoming Thanksgiving holiday and anticipate continued demand for testing, we encourage communities to heed the advice of public health officials, such as practicing safe social distancing, wearing masks and postponing non-essential travel. Testing is a vital facet of a public health strategy, but testing alone is not going to stop the spread of the virus. We must take the actions necessary to contain the virus in all communities.”
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The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.
ACLA Update on PCR Testing Capacity For COVID-19
WASHINGTON, D.C. – As COVID-19 cases continue to surge across the United States, ACLA President Julie Khani issued the following statement:
“Yesterday, ACLA member laboratories collectively performed 495,000 COVID-19 PCR tests, reflecting an all-time daily high for our members. We continue to do all that we can to expand testing capacity and provide test results to patients, health care providers and public health agencies as quickly as possible. With demand for testing surging across the country, ACLA member laboratories are experiencing a significant increase in the volume of COVID-19 test orders. Clinical labs are also facing delays or cancellations on orders for critical supplies, such as pipette tips. In addition, specimen pooling, one of the many techniques labs have developed to more efficiently use supplies and increase capacity, is only applicable for populations at low risk or with low prevalence of infection, and is therefore currently limited due to increased positivity rates in communities across the country.
The surge in demand for testing will mean that some members could reach or exceed their current testing capacities in the coming days. In cases where the number of specimens received exceeds an individual laboratory’s testing capacity, there could be an increase in their average time to deliver results.
As we near the upcoming Thanksgiving holiday and anticipate continued demand for testing, we encourage communities to heed the advice of public health officials, such as practicing safe social distancing, wearing masks and postponing non-essential travel. Testing is a vital facet of a public health strategy, but testing alone is not going to stop the spread of the virus. We must take the actions necessary to contain the virus in all communities.”
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The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services
Serologic testing provides a surveillance strategy for the fight against COVID-19
Since the start of this public health crisis, ACLA member laboratories have developed and expanded a range of tests and methods to support patients – including the first at-home specimen collection kits, COVID-19 specimen pooling and the launch of novel RNA extraction methods. Separate from tests used to determine an active infection, the use of serologic or antibody testing analyzes a patients’ blood specimen for the presence of immune response proteins developed due to a viral exposure or infection. In addition to its use in developing therapeutics and as a vital tool in vaccine trials, widespread serologic testing helps experts determine the number of individuals exposed or infected with COVID-19. Also, it provides valuable information to support broader prevention, containment and mitigation strategies.
Specifically, serologic testing is a valuable surveillance tool to help public health experts learn about the level of exposure to a virus in a community. Serologic testing can also be a critical asset in determining resource allocation and public health interventions’ effectiveness in a pandemic. While we continue to study the science around the exact level or the duration of immunity against reinfection that SARS-CoV-2 antibodies may provide, we know that accurate and reliable serologic testing is fundamental to our national response efforts.
In July, researchers from Ascend Clinical, an ACLA member laboratory specializing in testing services for kidney disease, began collaborating with the Stanford University School of Medicine to understand the seroprevalence – the number of individuals who test positive for a certain disease – of SARS-CoV-2 antibodies across large populations. While the study focused specifically on patients receiving dialysis treatment, many of its findings have significant implications for the general population.
Researchers collected information from more than 28,000 randomly selected dialysis patients from across the United States. Ascend Clinical performed testing using the Siemens Atellica IM SARS-CoV-2 Total (COV2T) antibody assay and discovered that there were higher rates of SARS-CoV-2 antibodies in Black and Hispanic patients as well as those living in densely populated areas. The study also found significant regional variation – from less than 5 percent in the West to greater than 25 percent in the Northeast.
As of July, researchers from Ascend and Stanford estimated that fewer than 10 percent of U.S. adults possessed SARS-CoV-2 antibodies – a figure well below what experts say is necessary for herd immunity. The dialysis population may be ideal for studying the general spread of COVID-19 in the U.S. because these patients undergo monthly, routine blood draws and represent other similar COVID-19 risk factors. As the COVID-19 pandemic continues, applying these findings and the results from serologic testing to bolster our surveillance efforts can help tailor public health strategies and meet the needs of the most vulnerable communities impacted by COVID-19.
Protecting Our Nation Through Robust Access to COVID-19 Testing
Access to reliable and accurate COVID-19 testing remains critically important to all Americans. However, absent federal assurance that COVID-19 tests will be covered, patients continue to face a patchwork coverage system that drives uncertainty and undermines federal response efforts.
In June, new guidance from the U.S. Department of Health and Human Services, Labor and Treasury muddied the clear coverage mandates passed by Congress that require group health plans and health issuers to cover COVID-19 testing without cost sharing or prior authorization.
As a result, federal protections that Congress promised to patients have significantly eroded over the past several months.
As a group of 54 bipartisan lawmakers recently noted in a letter to Secretary Azar, there has been an increase of coverage denials from health plans for COVID-19 testing, particularly for asymptomatic individuals. Today, as the number of COVID-19 cases surge across the country, Americans still face barriers to accessing the COVID-19 testing they need for return-to-work, return-to-school or broader public health and surveillance purposes.
A recent New York Times piece further underscores the barriers and blurred lines around the costs associated with COVID-19 testing. Out of the three patients profiled in the story, all assumed that their testing would be covered. Unfortunately, due to murky federal guidance, these patients found themselves victim of coverage denials and high costs.
Because the tri-agency guidance states that testing for the purpose of screening or employment isn’t required to be covered by a patient’s insurance plan, individuals who face increased risks as essential workers may face cost barriers accessing COVID-19 testing. For example, despite federal mandates to test all nursing home workers at a frequency based on local positivity rate, coverage barriers caused by the tri-agency guidance may continue to leave nursing home employees at risk and pose additional challenges to keeping nursing home residents safe.
Patients need certainty that their COVID-19 tests will be covered. As clinical laboratories, we know that each and every highly-accurate COVID-19 test holds a vital purpose, both for the individual patient and for the broader community. Information gleaned from even a single test can help inform mitigation efforts and in turn, save lives.
It’s with this value in mind that ACLA member laboratories have been working around the clock since March—many laboratories operating three shifts a day—to expand capacity and push forward innovations to meet the evolving needs of patients.
Expanding coverage of and access to COVID-19 testing should be a top priority in the next presidential term. Patients are counting on elected leaders to strengthen coverage requirements to ensure testing is covered with no cost sharing for all Americans. By closing persistent coverage gaps, we can better protect our nation and further promote our shared goal of safely reopening our local economies, workplaces and schools.
ACLA Statement on Key Priorities for the Incoming Biden Administration, New Congress
WASHINGTON, D.C. – Following the election of former Vice President Joe Biden, ACLA President Julie Khani issued the following statement:
“ACLA and its members congratulate Joe Biden and Kamala Harris on winning the election and stand ready to support the Biden Administration as it confronts the greatest public health threat in a century. We commend the Biden Administration for making it a top priority to ensure that all Americans have access to accurate and reliable testing. ACLA agrees that patients need certainty that their COVID-19 tests will be covered. This is a common-sense cause with bipartisan support.
Just yesterday, ACLA members hit a new all-time high for tests performed: 474,000 PCR tests in a single day. As positivity rates continue to climb across the United States, ACLA and its members remain focused on adapting platforms and workflows, deploying new strategies to conserve supplies, navigating supply constraints and working creatively and collaboratively to drive innovation and support our public health partners.
Meeting the evolving needs of patients nationwide requires significant investment in high precision instruments, adequate testing supplies, a highly trained workforce, modernized reporting systems, cutting edge research and specialized transportation logistics. We look forward to working with the Biden Administration and the new Congress to ensure labs can make these investments and increase capacity for the innovative diagnostics our country needs, now and in the future.”
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The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.
Lab Professionals Change Lives Every Day – Just Ask Rachael Malmberg
Every day, laboratory professionals use their expertise to perform complex diagnostic testing to help doctors, patients and families piece together the full picture of health. As both a patient and a director of patient engagement, Rachael Malmberg has a one-of-a-kind perspective into the dedication and innovation driving the laboratory industry.
In 2017, as a young mother and former professional hockey player for the U.S. Olympic team, Rachael watched as her life changed forever with a simple diagnosis – Stage IV adenocarcinoma. But with the help of an advanced diagnostic test, Rachel’s doctors discovered the presence of a mutation that allowed her to use a targeted therapeutic treatment, effectively saving her life.
Today, Rachael works for NeoGenomics Laboratories’ Informatics department, developing a patient portal that provides actionable information and resources based on patients’ cancer diagnoses. Her work is grounded in a greater understanding and appreciation of the patient experience as she continues to navigate it herself.
“When you’re going through the diagnosis process, I don’t think you fully understand and are aware of all the different people who are working together to find the best answer for you,” Rachael said. Laboratory professionals all across the country work behind the scenes performing high-complexity diagnostic tests and delivering often life-saving results for the patients on the other end of the test.
Reflecting on her own journey, Rachael understands just how invaluable dedicated lab professionals are to better health. Meeting Dr. Hummel for the first time – the molecular pathologist who read her slide – Rachael expressed just how grateful she is to have had a fully invested lab team. “The fact that I get an opportunity to thank you for reading my tests, you saved my life and changed the trajectory of what I am going and most importantly the treatment I am on giving me a better quality of life,” shared Rachael.
When the two finally met, virtually, Rachael expressed her deep gratitude to Dr. Hummel for the role she played, as well as the role all lab professionals play, in providing life-saving diagnostic care. “I’ve been a recipient of what you’ve done, and so I know the importance of helping people understand what you do behind the scenes,” shared Rachael.
Providing her perspective from inside the lab, Dr. Hummel explains that “Usually, I’m just thinking, if I slow down or if I get a drink of water, that’s two more results I can’t get to someone. So, it’s kind of nice to just put an actual person behind it and remember what the results are doing.”
Watch below for highlights from the interview with both Rachael Malmberg and Dr. Jennifer Hummel and to learn more about the critical work performed by laboratory professionals across the country.
ACLA Comments on VALID Act
ACLA Statement on CMS Policy: Cutting lab reimbursement won’t address the root causes of delayed turnaround times
Washington, D.C. – Following today’s announcement by Centers for Medicare & Medicaid Services (CMS) on Medicare reimbursement rates for COVID-19 testing, ACLA President Julie Khani issued the following statement:
“We are currently reviewing how this policy change will impact laboratories and the patients we serve.
ACLA member laboratories have already implemented innovative solutions and reworked operations to support increased COVID-19 testing capacity and faster turnaround times.
We’re concerned this policy could create a domino effect where patient access to testing is severely reduced. Cutting laboratory reimbursement won’t address the root causes of delayed turnaround times. Turnaround time is driven largely by fluctuations in demand and access to critical supplies. As states across the country experience a surge in new cases, the global demand for testing supplies remains high.”
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The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.
ACLA Statement on FDA Announcement Regarding EUA Reviews
Washington, D.C. – Following the recent FDA decision to no longer review emergency use authorizations (EUAs) for lab-developed COVID-19 testing, ACLA President Julie Khani released the following statement:
“Many of the tests that have been granted EUAs for COVID-19 testing are innovative, high-throughput LDTs that have reduced reliance on supplies and been integral to expanding testing capacity. These are exactly the kinds of tests that FDA has stated it wants to prioritize. ACLA believes the FDA should continue to allow labs to voluntarily submit EUAs for FDA review and authorization. Today’s announcement by the FDA creates unnecessary confusion.”
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The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.
