PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

Study models economic impact of proposed law to regulate high-risk diagnostic tests

Potential impact to health care costs will depend on key details in the bill's final language.

2021-04-21
(Press-News.org) BOSTON - Legislation currently under consideration in the U.S. Congress would increase regulatory oversight of certain diagnostic tests, and a new study by researchers at Massachusetts General Hospital (MGH) and colleagues from several other institutions demonstrates that its potential impact will depend on key details in the bill's final language. This study, published in JCO Oncology Practice, offers the first evidence-based analysis of how new rules proposed for the regulation of laboratory-developed tests (LDTs) could affect health care costs in the United States.

"The idea of having more oversight of LDTs is justified," says Jochen Lennerz, MD, PhD, medical director of the MGH Center for Integrated Diagnostics (CID) and the study's senior author. "But our results show that it's very important to align the language in this new law with the intent of what it's trying to accomplish."

From a regulatory standpoint, there are two categories of in vitro clinical tests (IVCTs), which include diagnostic tests performed in a test tube, culture dish, or elsewhere outside a living organism. Manufactured tests for many different conditions are commercially available. The Food and Drug Administration (FDA) closely regulates these tests, requiring manufacturers to submit data for premarket approval before they can be sold. However, clinical laboratories at hospitals and in other health care settings can create their own IVCTs for use in-house, which are known as LDTs. Currently, the FDA does not require premarket approval of LDTs and exercises little oversight of their use.

LDTs serve a variety of purposes, but one critically important role is identifying patients for novel drug therapies that target specific DNA variations, particularly if a commercial test is not yet available. This form of therapy, known as personalized medicine, is becoming increasingly important in cancer treatment.

Unfortunately, faulty IVCTs can produce inaccurate results, causing some patients to forgo potentially beneficial treatments and others to receive unnecessary and potentially harmful therapies. The proposed legislation, currently known as the Verifying Accurate and Leading-edge IVCT Development (VALID) Act, clarifies the authority of the FDA over all diagnostics tests.

If passed, VALID would focus on so-called high-complexity IVCTs, which have the greatest potential for patient harm if the results are incorrect. To comply with VALID, clinical laboratories would have to demonstrate accuracy of their LDTs, which includes a process called technology certification.

Lennerz believes that the stringency of how VALID is interpreted, which is not currently defined in the bill, will influence whether the proposed law can improve the quality of LDTs without significantly increasing future health care costs. He joined lead author Richard Huang, MD, and several colleagues in an effort to model the overall expense of maintaining the technology certification framework under VALID for cancer diagnostics. They based their estimates on 2019 data from CID, which performs more than 10,000 high-complexity LDTs for MGH patients each year.

The study found that maintenance costs for a lab performing that volume of LDTs would be $638,000 a year under low stringency and slightly higher ($685,000) under moderate stringency, but soar to $1.2 million under highly stringent enforcement. Extrapolating that data to reflect the added expense for the nation's 886 cancer treatment centers, complying with VALID would increase U.S. health care costs by $565 million, $606 million, or $1.1 billion over a three-year period, depending on stringency of enforcement.

Lennerz believes the study's important contribution is putting a price tag on VALID, which no one has yet done. "The key finding is that maintaining this new infrastructure will come at a cost," he says.

And while those numbers may seem high to some, they should be kept in perspective, says study co-author Jeff Allen, president and CEO of Friends of Cancer Research, a nonprofit patient advocacy organization in Washington, D.C.: "In the United States, we consistently see increases in health expenditures in the realm of $200 billion annually." Even with added FDA enforcement, the increased costs of VALID amounts to less than 0.5% of annual increased expenditures, he notes. "At the gain of assured quality in testing, the avoidance of medical errors, and improved support for medical decisions, the costs offset. But most important, patient care will improve," says Allen. VALID has bipartisan support in both houses of Congress, which will likely begin debate on the bill in early summer.

INFORMATION:

Huang is a former clinical informatics fellow in the Department of Pathology at MGH. Lennerz is also an associate professor of Pathology at Harvard Medical School.

About the Massachusetts General Hospital Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The Mass General Research Institute conducts the largest hospital-based research program in the nation, with annual research operations of more than $1 billion and comprises more than 9,500 researchers working across more than 30 institutes, centers and departments. In August 2020, Mass General was named #6 in the U.S. News & World Report list of "America's Best Hospitals."

About Friends of Cancer Research Friends of Cancer Research (Friends) is working to accelerate policy change, support groundbreaking science, and deliver new therapies to patients. We unite scientists, pharmaceutical companies, and policy makers with shared trust and guide them toward meaningful cooperation. This collaboration among partners from every healthcare sector ultimately drives advances in science, policy, and regulation that speed life-saving treatments to patients. For more information, please visit https://friendsofcancerresearch.org/.



ELSE PRESS RELEASES FROM THIS DATE:

Inflammatory diet linked to testosterone deficiency in men

2021-04-21
April 21, 2021 - Consuming a diet high in pro-inflammatory foods - including foods that contain refined carbohydrates and sugar as well as polyunsaturated fats - may be associated with increased odds of developing testosterone deficiency among men, suggests a study in The Journal of Urology®, Official Journal of the American Urological Association (AUA). The journal is published in the Lippincott portfolio by Wolters Kluwer. The risk of testosterone deficiency is greatest in men who are obese and consume a refined diet that scores high on the dietary inflammatory index (DII), according to the new research by Qiu Shi, MD, Zhang Chichen, MD, and colleagues of ...

Right to food strategy could eliminate food waste on farms

2021-04-21
A national strategy to ensure that families have access to food could revolutionize Canada's farms, according to a new study from Simon Fraser University's Food Systems Lab. The study proposes implementing a "right to food" framework that would support the needed funding, infrastructure, and stability that can reduce losses of edible food at the farm, while creating better access to local foods for consumers. The study, published in the journal Resources, Conservation and Recycling, looked at the reasons for on-farm losses of edible food. Approximately 14 per cent of the world's food is lost before it ever reaches store shelves. In Canada, 35.5 million metric tonnes of food are lost or wasted annually, ...

Stem cell therapy promotes recovery from stroke and dementia in mice

Stem cell therapy promotes recovery from stroke and dementia in mice
2021-04-21
A one-time injection of an experimental stem cell therapy can repair brain damage and improve memory function in mice with conditions that replicate human strokes and dementia, a new UCLA study finds. Dementia can arise from multiple conditions, and it is characterized by an array of symptoms including problems with memory, attention, communication and physical coordination. The two most common causes of dementia are Alzheimer's disease and white matter strokes -- small strokes that accumulate in the connecting areas of the brain. "It's a vicious cycle: ...

Host, management, or microbial traits: Which is dominant in plant microbiome assemblage?

Host, management, or microbial traits: Which is dominant in plant microbiome assemblage?
2021-04-21
We've all heard the news stories of how what you eat can affect your microbiome. Changing your diet can shift your unique microbial fingerprint. This shift can cause a dramatic effect on your health. But what about the microbiome of the plants you eat? Scientists are beginning to see how shifts in plant microbiomes also impact plant health. Unlocking the factors in plant microbial assemblage can lead to innovative and sustainable solutions to increase yield and protect our crops. In a new study published in the Phytobiomes Journal, "Influence of plant host and organ, management strategy, and spore ...

Study provides detailed look at intriguing property of chiral materials

2021-04-21
BUFFALO, N.Y. -- In nature, many molecules possess a property called chirality, which means that they cannot be superimposed on their mirror images (like a left and right hand). Chirality can influence function, impacting a pharmaceutical or enzyme's effectiveness, for example, or a compound's perceived aroma. Now, a new study is advancing scientists' understanding of another property tied to chirality: How light interacts with chiral materials under a magnetic field. Prior research has shown that in such a system, the left- and right-handed forms of a material absorb light differently, in ...

Study explains 'cocktail party effect' in hearing impairment

2021-04-21
Plenty of people struggle to make sense of a multitude of converging voices in a crowded room. Commonly known as the "cocktail party effect," people with hearing loss find it's especially difficult to understand speech in a noisy environment. New research suggests that, for some listeners, this may have less to do with actually discerning sounds. Instead, it may be a processing problem in which two ears blend different sounds together - a condition known as binaural pitch fusion. The research, co-authored by scientists at Oregon Health & Science University and VA Portland Health Care System, was published today in the Journal of the Association for Research ...

Why climate change is driving some to skip having kids

2021-04-21
When deciding whether to have children, there are many factors to consider: finances, support systems, personal values. For a growing number of people, climate change is also being added to the list of considerations, says a University of Arizona researcher. Sabrina Helm, an associate professor in the Norton School of Family and Consumer Sciences in the College of Agriculture and Life Sciences, is lead author of a new peer-reviewed study that looks at how climate change is affecting people's decisions about whether to have children. "For many people, the question of whether to have children or not is one of the biggest they will face in their lives," Helm said. "If you are worried ...

A receptor that controls appetite presents a target for anorexia, suggests mouse study

2021-04-21
By targeting a receptor in the brains of mice, researchers have successfully altered feeding and anxiety-like behaviors linked to anorexia. Although more work is needed in humans, their study suggests that fine-tuning the receptor's activity could help change feeding habits and promote weight gain in patients with eating disorders. Anorexia and other eating disorders affect at least 28 million Americans and cause more than 10,000 deaths in the U.S. each year, according to the National Association of Anorexia Nervosa and Associated Disorders. Studies have linked anorexia to neurons that bear a protein named AgRP; these neurons reside in an area of the brain ...

The wave beneath their wings

2021-04-21
Video: https://bit.ly/pelicanflightvideo It's a common sight: pelicans gliding along the waves, right by the shore. These birds make this kind of surfing look effortless, but actually the physics involved that give them a big boost are not simple. Researchers at the University of California San Diego have recently developed a theoretical model that describes how the ocean, the wind and the birds in flight interact in a recent paper in Movement Ecology. UC San Diego mechanical engineering Ph.D. student Ian Stokes and adviser Professor Drew Lucas, of UC San Diego's Department of Mechanical and Aerospace Engineering ...

Antibiotics protect apples from fire blight, but do they destroy the native microbiome?

Antibiotics protect apples from fire blight, but do they destroy the native microbiome?
2021-04-21
Like humans, certain plants are treated with antibiotics to ward off pathogens and protect the host. Saving millions, antibiotics are one of the 20th century's greatest scientific discoveries, but repeated use and misuse of these life-saving microbial products can disrupt the human microbiome and can have severe effects on an individual's health. Overuse has led to several microbes developing resistance to the antibiotic, rendering it useless, and created "superbugs" that overpower medication. But do we find that same phenomenon in plants and our food industry? This was the question Dr. Anna Wallis ...

LAST 30 PRESS RELEASES:

Program takes aim at drinking, unsafe sex, and sexual assault on college campuses

Inability to pay for healthcare reaches record high in U.S.

Science ‘storytelling’ urgently needed amid climate and biodiversity crisis

KAIST Develops Retinal Therapy to Restore Lost Vision​

Adipocyte-hepatocyte signaling mechanism uncovered in endoplasmic reticulum stress response

Mammals were adapting from life in the trees to living on the ground before dinosaur-killing asteroid

Low LDL cholesterol levels linked to reduced risk of dementia

Thickening of the eye’s retina associated with greater risk and severity of postoperative delirium in older patients

Almost one in ten people surveyed report having been harmed by the NHS in the last three years

Enhancing light control with complex frequency excitations

New research finds novel drug target for acute myeloid leukemia, bringing hope for cancer patients

New insight into factors associated with a common disease among dogs and humans

Illuminating single atoms for sustainable propylene production

New study finds Rocky Mountain snow contamination

Study examines lactation in critically ill patients

UVA Engineering Dean Jennifer West earns AIMBE’s 2025 Pierre Galletti Award

Doubling down on metasurfaces

New Cedars-Sinai study shows how specialized diet can improve gut disorders

Making moves and hitting the breaks: Owl journeys surprise researchers in western Montana

PKU Scientists simulate the origin and evolution of the North Atlantic Oscillation

ICRAFT breakthrough: Unlocking A20’s dual role in cancer immunotherapy

How VR technology is changing the game for Alzheimer’s disease

A borrowed bacterial gene allowed some marine diatoms to live on a seaweed diet

Balance between two competing nerve proteins deters symptoms of autism in mice

Use of antifungals in agriculture may increase resistance in an infectious yeast

Awareness grows of cancer risk from alcohol consumption, survey finds

The experts that can outsmart optical illusions

Pregnancy may reduce long COVID risk

Scientists uncover novel immune mechanism in wheat tandem kinase

Three University of Virginia Engineering faculty elected as AAAS Fellows

[Press-News.org] Study models economic impact of proposed law to regulate high-risk diagnostic tests
Potential impact to health care costs will depend on key details in the bill's final language.