ACLA: Clinical Labs Hold ‘The Power Of Knowing’ For Patients

ACLA wants policymakers to see the vital role clinical labs play in delivering better health outcomes for patients and improving public health, especially in their potential for catching diseases early.

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The best way to fight any disease is to keep it from developing in the first place.

And that is the message the American Clinical Laboratory Association (ACLA) wants to hammer home to policymakers inside the Beltway and stakeholders across the country.

ACLA’s Power of Knowing campaign emphasizes the essential role clinical labs play in using diagnostics to pinpoint diseases in their earliest stages. In some cases, this means identifying conditions before the patient begins to show symptoms.

During a panel discussion on the Power of Knowing at the ACLA Annual Meeting in Washington, DC last week, Kirsten Thistle of Reservoir Communications Group said the purpose of the association’s campaign is to show lawmakers how valuable clinical labs are in creating state of the art diagnostics in fighting, and preventing, a range of diseases.

Through the campaign’s website and an ongoing advertising blitz, ACLA stresses how clinical labs are on the edge of innovation in diagnostics, from rapid whole genome sequencing to biomarker testing. The group wants to build awareness that work done in labs is critical to the diagnosis and treatment of cancers, autoimmune conditions, diabetes, substance use disorder, and sexually transmitted diseases.

And starting this month, Thistle said the campaign is sharpening its focus on prevention.

Thistle cited cervical cancer statistics to underscore the importance of early detection. About 91% of patients diagnosed with stage 1 cervical cancer are still alive five years later, while the survival rate dips to 17% for patients diagnosed at a later stage.

“There’s still a wide swath of patients with metastatic advanced disease who are not receiving comprehensive biomarker testing. And if they’re not, then they’re at risk of having much worse outcomes.”

Nikki Martin

March is also Autoimmune Awareness Month, and ACLA plans to highlight the significant role clinical lab testing plays in diagnosing and managing autoimmune diseases, such as multiple sclerosis and lupus.

As the campaign notes, clinical labs are using AI to analyze tissue data to provide advanced diagnoses for many diseases. For example, AI can compare vast amounts of genetic data from patient records to genomic profiles to recognize patterns beyond human ability, which can help clinicians detect diseases earlier and more accurately.

Rapid whole genome sequencing, another innovation, can guide clinicians to specific therapies that can alleviate symptoms in some rare pediatric conditions.

NIKKI MARTIN

Another example is the use of blood samples to conduct liquid biopsy tests, which can identify multiple cancers at an early stage, leading to more targeted treatments.

ACLA’s campaign points out that clinicians are already using liquid biopsies, which are less invasive and more easily repeated than traditional tissue biopsies, to monitor treatment and better understand changes to an individual cancer diagnosis over time.

These innovations also reduce costs.

For instance, routine tests such as the A1c, complete blood count (CBC), and comprehensive metabolic panel not only help patients manage their health but aid clinicians in delivering more personalized treatment plans, which can slow disease progression and lower overall health care costs.

By better understanding disease characteristics and harnessing cutting-edge technologies developed in labs, ACLA says, providers are advancing to a world in which treatments are tailored to an individual patient instead of a “one size fits all” approach.

Biomarkers are Everything

Panel member Nikki Martin, senior director of precision medicine initiatives at the LUNGevity Foundation, spoke of the importance of biomarker testing for diagnosing lung cancer.

Biomarker testing analyzes blood, tissue, or bodily fluids to detect molecules that indicate disease through such characteristics as DNA mutations, protein level changes, and gene pattern variations. The benefits of biomarker testing are enormous, according to Martin, in that they allow clinicians to zero in on the right treatment for a particular disease, such as precisely targeting a specific cancer.

In 2022, the Medical Device Innovation Consortium (MDIC) launched an initiative to enhance cancer diagnostics through next-generation sequencing, which studies genetic variations in DNA or RNA to help detect and diagnose medical conditions.

The initiative analyzes somatic cells, which include all cells in the body other than sperm and egg cells. Somatic testing looks for gene mutations that could point to cancer.

“It’s remarkable where we are today with Alzheimer’s and dementia research. The momentum is palpable among the research community.”

Rebecca Edelmayer

Pathologists studying the histology of lung cancer, in Martin’s view, should also include biomarkers.

“For patients with non-small cell lung cancer, biomarkers are everything,” Martin said. “If a patient doesn’t have their biomarkers profiled for them at diagnosis and again at progression, there’s a very real chance that they would be put on the incorrect therapy that could lead to them having real harm in their health. So, we view biomarkers as critical.”

In general, she said, biomarker testing should be included in the standard of care.

“But right now that’s not the case for many patients,” Martin added. “There’s still a wide swath of patients with metastatic advanced disease who are not receiving comprehensive biomarker testing. And if they’re not, then they’re at risk of having much worse outcomes.”

Alzheimer’s Advancements

One of the most daunting diseases to diagnose and treat, and one of the most dreadful not only for patients but their loved ones, is Alzheimer’s.

But there has been progress, according to panel member Rebecca Edelmayer, vice president of scientific engagement at the Alzheimer’s Association.

“It’s remarkable where we are today with Alzheimer’s and dementia research,” Edelmayer said. “The momentum is palpable among the research community. We’re now starting to see the shift into implementation and more types of tools and technologies being available to clinicians to help patients.”

Advancements in plasma and blood biomarker testing are producing earlier and more accurate diagnoses, said Edelmayer, who noted that breakthroughs in Alzheimer’s and dementia began in the 1990s with cerebral spinal fluid and bio fluid analysis.

Though the fight against Alzheimer’s has not advanced to the degree of other diseases, such as cancer, Edelmayer said things are moving in the right direction.

“There’s never going to be a single test to help diagnose Alzheimer’s disease. We recognize that it’s going to be a combination approach,” she said. “It’s important for patients to get an early diagnosis because there’s medical, social, and even financial benefits to knowing what’s happening with their health.”

“It’s really important that we continue to make sure that diagnostics, treatment, and care are all linked together.”

Elyse Oveson

And while there is no cure for Alzheimer’s, treatments are advancing alongside diagnostics.

For example, Edelmayer referenced molecular treatments that target beta-amyloid plaque, which are abnormal clumps of protein in the brain and a hallmark of Alzheimer’s disease.

We need to know whether you have beta-amyloid plaque in the brain,” Edelmayer said, adding that current Alzheimer’s treatments are aimed at slowing the disease’s progression.

Another weapon in the Alzheimer’s fight is digital assessment technology, which as Medtech Insight reported last year, has the potential to detect symptoms before they appear.

“Using some of these biomarkers to help confirm Alzheimer’s disease pathology is a really critical part of the process,” she said. “We know that misdiagnosis happens a lot. We know we’re battling even larger stigmas about awareness of Alzheimer’s disease and other types of dementia. So, we have a lot of hurdles that we still need to cross.”

In March 2024, the US FDA recognized the evolving role of biomarker testing in its guidance on early Alzheimer’s drug development.

Access

But none of these advancements can help patients if they do not have access to them, which is a message the ACLA wants lawmakers on both sides of the aisle to hear, according to Elyse Oveson, chief of advocacy operations at ACLA, who moderated the panel.

ACLA says it is working with Congress on crafting new legislation to reform Medicare reimbursement fees to protect patient access to essential laboratory services. Reform is necessary as Medicare payment to clinical laboratories paid under the Clinical Laboratory Fee Schedule has been flat or reduced in 19 of the last 26 years.

ACLA believes there are flaws in the Protecting Access to Medicare Act, or PAMA, which Congress passed in 2014 requiring Medicare rates for clinical laboratory services to be based on private payer rates.

A common sense, long-term solution, the association argues, would provide payment stability and predictability for the Medicare program and clinical laboratories and ensure comprehensive private payer data are used to calculate Medicare rates, helping to facilitate investment in innovative diagnostics.

“The association is working hard to demonstrate to policymakers the value of clinical laboratory testing through the Power of Knowing as they make policy decisions on reimbursement and clinical laboratory infrastructure that’s necessary for robust patient access to these innovative diagnostics,” Oveson said.

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