One of healthcare’s most extensive and rapidly expanding market segments, Point-of-Care (POC) and At-Home Diagnostic Testing, has become an ever-increasing crucial topic within the medical market. Accelerated by the past few years’ dire needs for democratized diagnostic offerings and fed by the cooperation of regulatory agencies worldwide, diagnostic technology has advanced in recent years what may have taken considerably longer otherwise. As a result, innovative new platforms and future applications with the potential to revolutionize healthcare have emerged.

MIDI’s white paper will deep dive into Point-of-Care & At-Home Diagnostic Testing, covering a number of high-level subjects, including; Current Demands, Future Opportunity, Regulatory & Data Privacy Challenges, Market Advancements and Technology Assessment. Further detail contained within the white paper will afford the reader insight into:

1. The four primary areas of diagnostic testing experiencing rapid growth and advancement.
2. Critical considerations for device developers and manufacturers looking to create their next-generation diagnostic devices.
3. The current and emerging diagnostic testing methods and their value as applied to POC and at-home applications.

The post The Global Democratization of Point-of-Care & At-Home Diagnostic Testing appeared first on AdvaMed.

WASHINGTON, D.C. – Today, Zach Rothstein, Executive Director of AdvaMedDx, testified before the House Energy and Commerce Committee, Subcommittee on Health during a hearing on diagnostic test regulation and FDA’s proposed laboratory developed test (LDT) rule.

In his written testimony, Rothstein urged Congress to pass diagnostic regulatory reform, “The current regulatory framework for diagnostics was established decades ago and has remained fundamentally unchanged despite dramatic advancements in the field.  That is why we have supported, and continue to support, comprehensive legislative reform that would result in a modernized regulatory framework that spurs innovation and access to testing and is applied to all diagnostic tests based on their level of risk.

“We appreciate the interest of members of Congress from both sides of the aisle on this issue in recent years, and the leadership of Reps. Bucshon and DeGette in developing the Verifying Accurate Leading-Edge In Vitro Clinical Test Development (“VALID”) Act.

“Maintaining two very different oversight mechanisms for tests that are used for the same clinical purposes, with the differences in regulatory oversight often opaque to providers and patients, is not favorable for public health.  Moreover, it stifles investment in, and deployment of, IVDs nationwide due to the market dynamics and incentives it fosters.  

“Regulatory certainty is crucial for fostering a favorable environment for innovation.  A unified oversight program would clarify regulatory expectations, reducing the ambiguity that currently hampers investment decisions.  A clear regulatory landscape is instrumental in encouraging innovation of new and improved diagnostic tests.”

Also outlined in his testimony, Rothstein highlighted the key features of a modernized regulatory framework:

• FDA Oversight: A modernized, unified regulatory framework for all diagnostic tests should be overseen by FDA under the FDCA.
• Review Standard Tailored to IVDs and Ensures Patient Safety: The framework should include a premarket review standard that is clearly defined for diagnostics as analytical and clinical validity.  This standard should apply the gold standard of safety and effectiveness in a manner that is specifically tailored for diagnostic tests to ensure accurate and high-quality tests.
• Transparency for Patients and Providers: A public repository of critical, descriptive information about each test offered to patients and providers should exist and include the pathway by which a test is marketed, substantiated claims of intended use, summary analytical and clinical validation information, and conformance with standards.  
• Risk-Based, Flexible Framework: The framework should provide for a risk-based and flexible approach to regulation.  FDA review and oversight resources should be squarely focused on tests, and on modifications to existing tests, that pose greater risks to patients, while exempting from premarket review low-risk, well-established tests, and utilizing mitigating measures to support a least-burdensome regulatory approach.
• Ensuring Access to Testing for Unmet Needs: A modernized regulatory approach to IVDs must provide a reasonable path to market for tests that meet an unmet need, including for pediatric patients and rare disorders, some of which do not fall within the humanitarian device exemption yet are critical to public health.  
• Modernized Review Pathways: Updated review pathways should provide FDA necessary oversight tools while accommodating innovation and improvements in testing. These reforms would build upon recent legislative reforms applicable to devices generally, such as predetermined change control plans.
• Point-of-Care, Including Home Testing: A crucial aspect of a modernized framework must recognize that point-of-care diagnostics are critical to the future of healthcare.  CLIA-waived tests (e.g., physician offices, clinics) play a vital role to support public health, including advancing health equity. The COVID public health emergency demonstrated the value in POC testing, including at-home testing, and at-home sample collection.  With the increasing need for timely POC diagnostics from emerging infectious disease to antibiotic resistance, and the benefits of broader access to testing in reducing health disparities, such technologies are integral to support access and timely care for patients.   
• Diagnostic Instrument Innovation: A modern framework should provide reform to ensure continued innovation in modern diagnostic instruments (sometimes referred to as “platforms”).  As part of a risk-based approach, well-designed policies should incentivize the development of new, as well as improvements to, existing instruments.  For instance, we recommend codification of FDA’s longstanding, pro-innovation policy known as the Replacement Reagent and Instrument Family Policy (“RRIFP”).
• Transition that Prevents Disruptions: Adoption of a modernized regulatory approach should be undertaken in a manner that avoids undue disruption to the testing market and does not result in delays in test reviews, by using an appropriate implementation timeline, providing for sufficient guidance and education about the new framework and review procedures, and providing necessary appropriated resources to support implementation.

# # #

The post In Congressional Testimony, AdvaMed Urges Passage of Diagnostic Regulatory Reform appeared first on AdvaMed.

Initiatives

Heart Month

This February, AdvaMed is working with member companies and our global partners to raise awareness and highlight the ways medical technology helps those living with cardiovascular disease live healthier, happier lives.

Initiatives

Medtech’s Role in Living a Heart Healthy Life

Each February, AdvaMed and our member companies work to raise awareness about heart health, emphasizing the importance of understanding, preventing, and managing cardiovascular disease. This disease, affecting millions of lives each year, is the leading cause of death in the United States. Through education, lifestyle changes, and advancements in medical technology, it is possible to reduce the impact of cardiovascular disease and live a heart-healthy life.

Join us in this month-long campaign to make a positive impact and promote healthy lifestyles for Americans living with cardiovascular disease.

Social Media Toolkit

Over the course of American Heart Month, AdvaMed and our partners encourage you to raise awareness about cardiovascular disease and the role of medtech in treating patients. Consider using the below graphics on your own social media channels or engaging with AdvaMed on X and LinkedIn.

Page / Workforce Inclusion & Diversity

Women in Cardiovascular Device Trials

AdvaMed members  have launched a public awareness campaign to encourage recruitment, enrollment and retention of women in cardiovascular device trials.

Facts About Cardiovascular Disease

• Cardiovascular disease (CVD) remains the leading cause of death in the United States, accounting for 928,741 deaths in 2020.
• In 2020, the leading cause of deaths attributable to CVD in the United States was coronary heart disease (CHD) at 41.2%, followed by stroke (17.3%), other CVD (16.8%), high blood pressure (12.9%), heart failure (9.2%), and diseases of the arteries (2.6%).
• The direct and indirect costs of total CVD in the United States between 2018 and 2019 were $407.3 billion ($251.4 billion in direct costs and $155.9 billion in lost productivity/mortality).
• On average, someone dies of CVD every 36 seconds in the United States.
• Globally, CVDs are the leading cause of death, accounting for 32% of all global deaths in 2019.

The Future of Cardiovascular Disease Treatment

• Wearable devices that monitor heart rate, blood pressure, oxygen saturation, and other vital signs, and alert patients and doctors of any abnormalities or emergencies.
• Artificial intelligence that analyzes large amounts of data from electronic health records, imaging, and wearable devices, and provides insights for diagnosis, prognosis, and treatment of cardiovascular disease.
• Stem cell therapy that uses the patient’s own cells to regenerate damaged heart tissue and improve cardiac function.
• Nanotechnology that delivers drugs or genes to specific targets in the heart, such as plaque, inflammation, or ischemia, and enhances the efficacy and safety of therapies.
• 3D printing that creates personalized models of the heart, valves, vessels, and implants, and facilitates surgical planning, simulation, and training.

Learn more about the history of cardiovascular disease treatment here.

Cardiovascular Patient Stories

Patient

Heart Valve Replacement Procedure Keeps Mick Jagger on a Roll

Patient

Intelligent Diagnostic Rescues Local Firefighter: Dennis’ Story

Patient

A Tiny Motor Powers a Device and Saves a Life

The post Heart Month appeared first on AdvaMed.

WASHINGTON, D.C. – Today, AdvaMedDx submitted comments in response to the Food and Drug Administration’s Proposed Rule: Medical Devices; Laboratory Developed Tests. AdvaMedDx is a division of AdvaMed representing companies that develop in vitro diagnostic (IVD) tests.

In the comments, AdvaMedDx outlines support for FDA’s statutory authority to regulate Laboratory Developed Tests (LDTs) while reinforcing the importance of legislative action through the bipartisan Verifying, Accurate, Leading-Edge IVCT Development (VALID) Act: “AdvaMedDx has consistently maintained that FDA possesses statutory authority to regulate LDTs as medical devices. Consequently, we believe FDA is fully within its purview to clarify the regulatory definition of in vitro diagnostics to encompass tests manufactured within a laboratory setting. While FDA, diagnostic test manufacturers, and the public would benefit significantly from comprehensive diagnostics regulatory reform, we acknowledge that such a transformation of the FDA’s regulatory environment likely necessitates an act of Congress.

“VALID or similar legislation could optimize FDA’s ability to establish a comprehensive, unified, modernized, diagnostics-specific, risk-based regulatory framework for all IVDs, including those manufactured by a laboratory, regardless of where they are developed, separate from medical devices. This framework, we firmly believe, must be risk-based to ensure that IVD regulation aligns with individual risk levels rather than the test’s developer. Adopting a modernized, risk-based framework would yield significant benefits to public health, expanding the reach of cutting-edge diagnostics, thereby enabling patients to reap the benefits more swiftly and widely, while simultaneously bolstering the confidence of patients and healthcare providers in the latest diagnostic technologies.”

The comments also called on FDA to prioritize a smooth implementation of the rule to minimize disruptions, including how FDA approaches submissions related to specimen collection devices and the potential impact to ongoing clinical studies involving investigational IVDs during the transition.

Read the full comments submitted by AdvaMedDx here.

AdvaMedDx is the only policy organization exclusively addressing issues facing the in vitro diagnostic industry in the United States and abroad. Diagnostic tests are a cornerstone of the healthcare industry: The Centers for Disease Control and Prevention estimates that 70 percent of all health care decisions rely on laboratory testing. members develop and manufacture innovative diagnostic technologies that support and advance public health and play an integral role in the work of clinical laboratories, as the tests laboratories run, including tests considered to be LDTs, often rely on instruments and equipment made by our members, or even utilize a test kit made by our members. In addition, our membership includes test developers that have pursued, and successfully obtained, FDA authorization of their own LDTs.

# # #

The post In Comments to FDA, AdvaMed Maintains Support of Agency’s Authority to Regulate LDTs appeared first on AdvaMed.

WASHINGTON, D.C. – Today, AdvaMedDx, a division of AdvaMed representing manufacturers of innovative in vitro diagnostic tests, sent a letter urging Congressional leaders to prioritize the reauthorization of the President’s Emergency Plan for AIDS Relief (PEPFAR) program. PEPFAR funding lapsed at the end of the fiscal year 2023.

The group wrote in the letter, “Ending HIV/AIDS as a public health threat requires a sustained commitment from the U.S. Government. In the last twenty years, PEPFAR has brought reliable medical technology, including diagnostic tests, and quality medicine to Africa and other regions around the world while reducing the global threat of disease. Without the U.S.’s continued, long-term investment in this work, the fight against HIV/AIDS could decelerate and the reliability of health systems in PEPFAR countries could falter.

“We are concerned by the recent lapse in PEPFAR funding and efforts to advance only a one-year reauthorization of PEPFAR, rather than a longer-standing reauthorization. We believe this uncertainty will lead to health system investments made through PEPFAR becoming shorter in duration, costing more, providing more limited functionality, and ultimately destabilizing capabilities for future pandemic response.”

The program, over the course of its 20-year history, has contributed to improved health outcomes across the more than 50 countries where PEPFAR operates, saving 25 million lives and providing 20.1 million people with necessary antiretroviral treatment. This has led to 5.5 million babies born HIV-free to mothers living with HIV and a substantial decline in new HIV diagnoses globally.

Read the full letter here.

The post AdvaMed Calls for Reauthorization of AIDS Relief Program appeared first on AdvaMed.

WASHINGTON – Today, AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker and Zach Rothstein, Executive Director of AdvaMedDx, on FDA’s recently proposed LDT rule:

“Last year, the bipartisan VALID Act was nearly passed by Congress, which would have accomplished a long-overdue modernization of the regulatory framework for diagnostics,” Whitaker said. “AdvaMed has been actively engaged in that effort because regulation of clinical diagnostics has not kept pace with advancements in the field, including those driving personalized medicine. We are evaluating FDA’s proposed rule, and we continue to urge Congress to adopt a modernized regulatory framework for diagnostics so that patients across the country have access to the best possible diagnostic tests.

“To better support patient care and public health, AdvaMed supports establishment of a single, modernized, diagnostics-specific, risk-based regulatory framework for all in vitro clinical tests (IVCTs), regardless of where developed, and overseen by FDA,” Rothstein said. “Such a framework would increase the reach of cutting-edge diagnostics, allowing patients to benefit more rapidly and broadly, and increase the confidence of patients and providers in the latest diagnostic technologies. We look forward to continuing our work on this issue.”

###

The post AdvaMed Statement on Proposed Laboratory Developed Test Rule appeared first on AdvaMed.

https://www.advamed.org/events/dx-summit/(opens in a new tab)

The post Dx Summit appeared first on AdvaMed.

WASHINGTON, D.C. –  Today, AdvaMed, the MedTech Association, released updated reports, in collaboration with Deloitte on frameworks for the comprehensive assessment of medical technologies and diagnostic tests. These seminal reports had been developed to help key stakeholders—payers, providers, health technology assessment bodies, patient advocates, and medtech companies – to assess the value of medical technologies in an emerging value-based care world.

The initial reports, released in 2017, marked the first time a value framework was developed for medical technology and diagnostic tests, and they made clear that there is a business imperative for medtech companies to understand, demonstrate, and clearly articulate how their offerings can create value for each of the key stakeholders across the health care delivery continuum. Since the initial framework was released in 2017, the medtech industry has seen significant changes and advancements, which has precipitated an updated framework. The latest version of the Medtech Value Framework also reflects the shifting attention towards Environmental, Social, and Governance (ESG) considerations for medtech companies and health care stakeholders.

“Whether it’s improvements to home monitoring, guided surgical care, or therapeutic interventions, digital health technology is changing the way patients take control of their health,” said Scott Whitaker, AdvaMed President and CEO. “Our industry is at the forefront of this rapid innovation in health care, which is why we are proud to collaborate with Deloitte on this important update to the Medtech Value Framework. We hope it is a valuable tool for medtech companies as they bring their life-saving technologies to patients.”

“It is a business imperative for medical technology innovators to understand, demonstrate, and clearly articulate how their offerings can improve patient outcomes and help health systems and payers create value,” said Glenn Snyder, Global MedTech practice leader and principal, Deloitte Consulting LLP. “In collaborating with AdvaMed on this new framework, our goal is to provide medtech leaders with a practical methodology to consider and address each stakeholder’s unique set of value drivers and ultimately articulate how their innovations benefit patients and create value for the healthcare ecosystem”

Additionally, AdvaMed and Deloitte have developed a report titled A Framework for Comprehensive Assessment of the Value of Diagnostic Tests. The diagnostic industry, along with the broader medtech industry, continues to innovate and provide life-saving resources to patients, but diagnostic companies face unique challenges that warrant this supplemental value framework. Advancements in digital diagnostic devices, including the incorporation of augmented intelligence (AI) and machine learning (ML) are just two novel factors stakeholders must consider as they assess the value of diagnostic technology. AdvaMedDx represents the leading manufacturers of in-vitro diagnostic tests.

Read the full report here.

# #

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

The post New AdvaMed, Deloitte Research Defines Medtech’s Value in Health Care Ecosystem appeared first on AdvaMed.

WASHINGTON, D.C. – Today, AdvaMed, the Medtech Association, joined members of the Global Medical Technology Alliance (GMTA) to welcome the recently released World Health Assembly (WHA) resolution on Strengthening Diagnostic Capacity. The resolution highlights the fact that resilient health systems rely on diagnostics at every level of health infrastructure and calls on Member States to expand skilled workforce training, advance regulatory harmonization, invest in research and development and manufacturing, and prioritize diagnostic services in their national strategies.
 
The resolution also acknowledges the role of the World Health Organization (WHO) in public health and calls on the organization to ensure a flexible and responsive regulatory and guidance environment that facilitates patient access to diagnostic innovations.

Thierry Bernard, QIAGEN CEO and AdvaMedDx Board Chair, said, “We applaud the WHA’s recognition of the significance of diagnostics in global health.  Exemplified by  the COVID-19 pandemic, diagnostics has proven its relevance in the healthcare value chain and have been critical in managing disease outbreaks, underlining their importance in saving lives.”

In a statement following the release of the resolution, GMTA, which is co-chaired by AdvaMed and MedTech Europe, said, “Diagnostics are included in the estimated two million different kinds of medical devices that are on the world market today.  Medical devices – and diagnostics specifically – play an essential role in improving, extending and saving lives every day, in every country in a wide range of circumstances:  chest images with computed tomography help diagnose coronary artery disease and detect cancers; ultrasound enables the detection of high-risk pregnancies; and diagnostic tests that can detect public health threats such as the SARS-CoV-2 coronavirus, malaria, and tuberculosis.
 
“Most recently, the COVID-19 pandemic highlighted diagnostics as an essential public health tool, since diagnostics provide crucial data that guides treatment decisions:  from diagnosing patients, to determining the scope, spread, and scale of infectious disease outbreaks.  Together with other measures – such as personal protective equipment, ventilators, and the use of vaccines – they protect and help treat our loved ones, as well as the broader community. 
 
“We thank the WHO for its leadership and look forward to collaborating with all stakeholders to accomplish the many goals and priorities set forth in this Resolution.  We also look forward to continuing our critical work with the WHO on a broader range of essential medical technologies.”

# # #

The post AdvaMed, GMTA Welcome World Health Assembly Resolution on the Importance of Diagnostic Products for Global Public Health appeared first on AdvaMed.

This Women’s Health Month, AdvaMed is highlighting new developments in breast cancer screening. 

The U.S. Preventive Services Task Force (Task Force) released new draft recommendations that women get screened for breast cancer every other year, starting at age 40. Previously, the Task Force recommended women in their 40s decide whether to get a mammogram on an individual basis, related to their health history and preference.  

The change came after “new and more inclusive science” indicated screening at an earlier age could result in 19 percent more lives being saved. 

While the prospect of saving lives is good news, tempering the cause for celebration is the disparate impact of breast cancer on Black women.  

As the Task Force stated, “Black women are 40 percent more likely to die of breast cancer than White women and too often get deadly cancers at younger ages. The Task Force recognizes this inequity and is calling for more research to understand the underlying causes and what can be done to eliminate this health disparity.”   

AdvaMed, representing the companies that make breast cancer screening and treatment technology, endorses the call to action to understand the causes of these pronounced disparities and to work to end them. 

AdvaMed adopted four Principles on Health Equity to guide our work on easing health disparities:  

• Promoting inclusion and equity in healthcare
• Partnering in education with stakeholders
• All patients deserve access to innovative technology
• Promoting research equity in the medtech industry 

Research equity requires more diversity in clinical trials. The lack of racial and ethnic diversity in clinical trials is well-documented. Fortunately, an increasing number of companies recognize the need for change and are casting a wider net in recruiting participants. More diverse clinical trials will also help AdvaMed member companies fulfill our principle of ensuring all patients have access to innovative medical technology. The trial results will inform how to close the gaps in access to mammograms, other screening modalities, and follow-up care at appropriate ages and intervals for Black, Hispanic, Asian, Native American, and Alaska Native women.  

Diverse clinical trial participants inform the understanding of how medical technology will perform across a larger percentage of the affected patient population. The results inform medtech development and shape screening guidelines, such as those from the Task Force. The Task Force is taking public comment on its draft recommendations through June 6. Stakeholders are already weighing in. 

For example, the Alliance for Women’s Health & Prevention expressed disappointment “that the draft guidelines do not include annual screenings or a recommendation for women with dense breasts.”  Breast density is a strong risk factor for breast cancer, and Black women tend to have denser breast tissue than White women. A recent study suggests interpretation of breast density changes over time could help inform risks and diagnoses. 

Comments and developments like these are important. They contribute to the robust, well-informed debate critical to developing and acting on more representative patient screening guidelines.  The dialogue must continue, and it will. Every woman deserves access to the screening necessary for the timely detection and diagnosis of breast cancer that are key to saving lives. 

The post Women’s Health Month: Closing Gaps in Breast Cancer Screening appeared first on AdvaMed.