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ACLA Statement on Updated VALID Act Introduced as Part of Senate FDA User Fee Package

ACLA News, All News, ACLA Press Releases, Regulatory Issues

Washington, D.C. – In response to the Senate Committee on Health, Education, Labor and Pensions’ (HELP) release of a bipartisan, updated version of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, as part of a legislative package that would renew various FDA user fee programs, ACLA President, Susan Van Meter, issued the following statement:  

“We commend Senate HELP Committee Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) for their leadership and commitment to a bipartisan legislative process. Today’s release of the updated VALID Act, which aims to establish a diagnostics-specific regulatory framework for all diagnostic tests, represents a pivotal moment in the multi-year effort on diagnostic regulatory reform.  

ACLA and our members are moving swiftly to review the discussion draft and will submit comments to the HELP Committee outlining our position on the policies included in the updated legislation. ACLA remains focused on ensuring that the new regulatory paradigm would fully recognize the critical role of clinical laboratories in public health and patient health, preserve and foster innovation in clinical laboratories, while maintaining access to empower providers and patients in health care decisions.  

ACLA members are high-complexity, CLIA-certified and CAP-accredited clinical laboratories and leaders on the forefront of medical innovation across virtually all areas of patient care and public health. Through the development and validation of laboratory developed tests (LDTs), ACLA members address unmet medical needs, aid diagnoses and guide treatment and prevention, which, taken together, reduce the cost and increase the quality of care available to patients. While laboratories have been driving innovation for decades across common and rare diseases alike, the pandemic has made the public acutely aware of the value of clinical laboratories and laboratory tests in facilitating informed and quality health care decisions. Laboratories need clarity and certainty in the regulatory environment to respond to public health emergencies, encourage innovation and develop the next generation of breakthrough technologies.”    

ACLA’s comments on the VALID Act, as introduced in the U.S. House of Representatives in 2021, are available here.

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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 and NACDS, 65 Patient Groups, Provider and Public Health Organizations Urge Congress to Replenish the HRSA COVID-19 Uninsured Relief Fund

ACLA News, All News, ACLA Press Releases

WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) and the National Association of Chain Drug Stores (NACDS) today sent a letter with over 60 leading organizations representing patients, health care professionals, hospitals, public health, laboratories, and diagnostic manufacturers urging Senate and House leaders to replenish the Health Resources and Services Administration (HRSA) COVID-19 Uninsured Relief Fund. In the letter, the organizations urged Congress to take immediate action and replenish the fund to protect Americans’ ability to access testing, treatments and vaccinations without cost-sharing. 

“Throughout the pandemic, federal COVID-19 funding supporting access to testing has been essential to our nation’s pandemic response,” said Tom Sparkman, ACLA Senior Vice President, Government Affairs and Policy. “As a result of the COVID-19 Uninsured Relief Fund, ACLA members have performed more than 8 million tests for uninsured individuals in 2021 alone. We must continue to support access to testing for all Americans, regardless of their insurance status, as testing remains a critical need to fight the pandemic.” 

HRSA, which administers the program, has been unable to reimburse providers for testing and treatment since March 22 and stopped accepting claims for vaccinations on April 5. The letter emphasizes that without Congressional action, providers across the country will be “left without recourse to handle the influx of demand from uninsured Americans, forcing them to make decisions about the long-term sustainability of providing COVID-19 tests and services.” 

The COVID-19 Uninsured Relief Fund originally was established by the Families First Coronavirus Response Act and has been replenished as needed throughout the pandemic, most recently through the 2021 American Rescue Plan Act. The COVID-19 Uninsured Relief Fund has successfully provided life-saving access to COVID-19 testing for uninsured individuals and ensured that all Americans could access testing, treatments and vaccinations when needed.

To view the full letter, click here. 

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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 Clinical Use of Non-invasive Prenatal Screenings (NIPS)

ACLA News, ACLA Press Releases, Regulatory Issues

Washington, D.C. – In response to recent interest in non-invasive prenatal screenings (NIPS) and their use by patients and health care providers, ACLA has issued the following statement:

“Health care providers rely on a variety of tools to help guide them through the diagnostic process. Screenings are used throughout a patient’s lifetime to detect potential health conditions, even if the patient currently is not exhibiting any symptoms of disease. A screening test provides information about the chance a person may be affected with a condition, whereas diagnostic tests are used to confirm the presence or absence of a condition.

NIPS is a screening test, not a diagnostic test, and does not provide definitive results for any genetic condition. NIPS is a non-invasive method to provide a preliminary assessment of potential risk for certain health issues and is not equivalent to, nor intended to be used as, a diagnostic test for specific fetal conditions. Ultimately, choices about prenatal screening are made by patients in close consultation with their health care provider.

The results of these screening tests can help health care providers including genetic counselors develop appropriate medical management plans with their patients. Chromosomal abnormalities can have profound consequences on the life and health of a child. Detecting this information early on in pregnancy can help families prepare and allow health care providers to recommend specialized care, before and after delivery.”

For more information on NIPS, you can see a fact sheet here on ACLA’s website.

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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 Announces Susan Van Meter as Next President

ACLA News, All News, Featured News, ACLA Press Releases

Washington, D.C. – ACLA Board Chair William G. Morice, MD, PhD, and President of Mayo Clinic Laboratories, today announced the Board’s selection of Susan Van Meter as ACLA’s next president.

“ACLA has been glad to call Susan a partner on the numerous issues facing the clinical laboratory industry, most recently during her time as Executive Director of AdvaMedDx,” said ACLA Board Chair Morice. “We’re thrilled to have her at the helm during this pivotal time for the industry. We know her two decades of experience as an advocacy association executive on a wide range of health care issues will serve us, and the people who seek the care our members provide, well.” 

As Executive Director of AdvaMedDx, Van Meter has directed the policy, advocacy, communications, regulatory, payment and legislative strategy and operations of the association, which represents manufacturers of in vitro diagnostic (IVD) clinical tests in the U.S. and abroad. In this role, she also developed the association’s robust response to the COVID-19 pandemic and ongoing advocacy efforts. 

“The last few years have clearly demonstrated that Americans depend on clinical laboratories and diagnostics each day and certainly in times of great personal and public health need, and I am thrilled to join ACLA to advance policies that extend the reach of quality testing to all. Clinical laboratories continue to serve an essential role in our nation’s recovery, providing COVID-19 testing, preparing for future emergencies and supporting patients catching-up on delayed medical care because of the pandemic, all while innovating to provide patients and clinicians with cutting edge diagnostics. I am eager to get to work with the incredible ACLA team and membership to advocate on behalf of America’s clinical laboratories and the patients they serve,” said Van Meter.

Prior to her role at AdvaMedDx, Van Meter served as the Senior Vice President of Federal Relations at the Healthcare Association of New York State (HANYS), where she was responsible for developing their priorities and strategies to further the interests of their hospital and health system members. She also previously worked in the Centers for Medicare & Medicaid Services’ (CMS) Office of Legislation. Van Meter holds undergraduate and graduate degrees from Villanova University and Boston University, respectively.

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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 Welcomes Califf Confirmation as FDA Commissioner

ACLA News, ACLA Press Releases

WASHINGTON, D.C. – Following the Senate confirmation of Robert Califf, M.D. as Commissioner of the U.S. Food and Drug Administration (FDA), the American Clinical Laboratory Association (ACLA), the nation’s leading organization representing clinical laboratories, today extended their congratulations to the next FDA commissioner. 

“ACLA extends our warm congratulations to Dr. Califf upon his confirmation to serve once again as FDA Commissioner,” said Tom Sparkman, ACLA Senior Vice President, Government Affairs and Policy. “We look forward to working with Dr. Califf on a variety of issues impacting our nation’s cutting-edge laboratories and the innovative services they provide to patients. Clinical laboratories are driving the next generation of patient-centered care delivery, utilizing both laboratory developed tests (LDTs) and in-vitro diagnostic test kits. 

For more than two years, clinical laboratories have played a crucial role in innovating and expanding access to a broad range of COVID-19 tests, including at-home specimen collection kits, specimen pooling, multiplex testing and the launch of novel RNA extraction methods to scale and maintain testing capacity and meet the growing demand.  We know that testing will remain integral to our nation’s pandemic response. 

As Dr. Califf lends his leadership and expertise to FDA, we look forward to working closely with him to advance policies and regulations that support a comprehensive approach to statutory diagnostic reform, including eliminating unnecessary and counterproductive regulatory policies that create uncertainty and impose unnecessary burdens on test development, especially as the country continues to tackle the COVID-19 pandemic and the resulting toll on patient health.”

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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.

The Role of Sustainable Testing in Ending the COVID-19 Pandemic

ACLA Blog, ACLA News

For the past two years, ACLA has emphasized how a sustainable testing strategy will help the country see a clear end to the pandemic and continues to highlight the importance of testing in an ongoing comprehensive pandemic strategy. Laboratories and hospitals nationwide agree with what President Biden recently echoed: that the U.S. should have been administering more COVID tests in the beginning stages of the pandemic. 

The full range of COVID-19 testing is an essential part of our national pandemic response. Testing provides accurate, reliable results to patients and providers – and in the case of the pandemic, to public health leaders as well. These critical tools allow us to diagnose and monitor cases of COVID-19, as well as help inform our public health responses at the national and local levels. 

COVID-19 testing has not only helped the clinical response to treat and manage COVID infections but has also helped Americans more safely live their lives, including seeing loved ones and returning to work, school and daily life. Since the outset of the pandemic, ACLA members have performed upwards of 188 million tests thanks to dedicated staff and technicians working around the clock every day. 

Whereas the early challenges clinical laboratories faced focused on bringing tests online and scaling capacity to meet the national demand, laboratories are subsequently dealing with staffing shortages and fluctuating demands for tests that make it difficult to appropriately scale to maximum capacity at a moment’s notice. As seen during the rise of the Omicron variant, clinical laboratories had to respond to the sudden surge in demand for testing while ensuring that the availability of non-COVID testing was not impacted. In addition to staffing concerns, insight into the ongoing availability and appropriate levels of supplies needed to maintain capacity, such as specimen collection tubes and pipette tips, presents a new long-term challenge.

With emerging SARS-CoV-2 variants continuing to spread, strengthened collaboration with the federal government, state health agencies, labs and manufacturers will help maintain expanded long-term test capacity and ensure tests are deployed where they’re needed most. A forward-looking, sustainable solution will help labs nimbly adapt to the pandemic in the long-run and help public health experts better predict, prepare for and respond to surges in cases and the rise of new variants – in addition to any future public health crises. 

ACLA has consistently supported establishing clear coverage guidelines and a long-term strategy to ensure all Americans have access to timely and reliable COVID-19 tests. A recent letter to the White House COVID Response Team called on the Biden Administration to formalize and make permanent communications and collaboration between the Administration, labs and diagnostic manufacturers, expand sample collection sites to leverage laboratory capacity and increase testing availability and provide comprehensive information to states about testing and the test types available. 

Effective pandemic response will continue to be critical as we move further into the new year. The following recommendations can better equip labs and health systems with the tools necessary to manage the recent COVID-19 surge and overcome unprecedented staffing and resource pressures:

  • Maintaining the extended reimbursement and coverage for COVID-19 testing under the Public Health Emergency Declaration to help ensure patients have access to testing and other health services when they need them most.
  • Providing clear guidance on:
    • Return-to-work protocols following a positive COVID-19 test result; 
    • How to appropriately utilize the different types (e.g., PCR, antigen, antibody) and settings (e.g. lab-based, point of care, home use) of COVID-19 testing; and
    • How health systems can best utilize internal COVID-19 testing capacity for health systems to handle acute inpatient cases and best leverage external reference laboratory capacity. 
  • Improving flexibility in utilizing laboratory developed tests (LDTs) to expand and maintain testing capacity, particularly to adapt to any potential supply shortages, new variants or new clinical uses, such as clinical use of variant sequencing.
  • Establishing and funding private-public collaborations that provide private-sector clinical laboratories with personnel, equipment and reserves of supplies, all of which are necessary to respond to sharp increases in testing demand.   

Testing must remain a critical component of our national COVID-19 response and a clear, sustainable plan for maintaining testing and surge capacity will become even more essential as we navigate the long-term impacts of the virus and its emerging variants – as well as prepare for future public health crises. ACLA and our members remain committed to working with the Administration and Congress to bring the pandemic to an end and are eager to collaborate on commonsense long-term approaches to public health testing that help laboratories meet the demand for efficient, reliable tests for communities across the nation every day. 

ACLA Statement on COVID-19 Testing Capacity and Turnaround Time

Public Health Preparedness and Infrastructure, ACLA News, ACLA Press Releases

Washington, D.C. – As cases of COVID-19 continue to surge across the country amid the current Omicron wave, ACLA issued the following statement:

“Since the outset of the pandemic in March 2020, ACLA member labs have been leading the way in developing, scaling and performing PCR COVID-19 tests and have performed upwards of 175 million tests since then. While we once again are facing a surge in cases and an uptick in demand for tests nationwide, ACLA members continue to prioritize expanding testing capacity to ensure that anyone who needs a test is able to get one – when they need to. 

In contrast to some of the industry-wide issues that were present in the early days of the pandemic, labs are now facing a wave of new issues brought on by a fast-spreading variant that has not spared the laboratory care work force. We are seeing at an industry level that staffing is a significant factor in determining overall capacity. Though individual labs can best speak to the specific issues they’re experiencing, ACLA members have reported the following issues factoring into overall capacity and turnaround time:

  • Hiring additional and/or temporary workers takes time and training and is occurring in an environment with competition among other health care sectors also experiencing workforce strain.
  • Some laboratory staff and capacity needs to be retained for critical non-COVID testing such as newborn screening and women’s health.
  • COVID-19 infections have increased laboratory staff sick leave.

Additionally, while testing supplies are currently stable, a sustained increase in demand for testing could lead to shortages, particularly in consumables such as specimen collection tubes and pipette tips. 

The ongoing surge in demand for tests can lead to an increase in average times to deliver results. ACLA continues to coordinate with members to monitor the situation and ensure both COVID-19 and routine testing is not disrupted. Additionally, we continue to engage the White House COVID-19 Task Force and the Biden Administration more broadly on the challenges identified above to ensure our members can maintain capacity and supplies, and so that the American people can continue to have access to timely and reliable tests. 

Testing remains a vital facet of our pandemic response, including the broad range of testing methods, such as at-home specimen collection kits, specimen pooling, multiplex testing and novel RNA extraction methods. But testing alone is not going to stop the spread of the virus. We encourage all communities to heed the advice of public health officials, such as getting vaccinated, practicing social distancing and wearing masks in crowded indoor spaces or in areas of substantial or high transmission.”

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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.