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Congress

Testifying During House Appropriations Hearing

Posted on by Lawrence Tabak, D.D.S., Ph.D.

Dr. Tabak seated at table speaking into microphine
It’s always an honor to represent NIH before members of Congress. On April 19, I did so before the U.S. House of Representatives’ Labor, Health and Human Services, Education subcommittee. I was invited to testify as part of the subcommittee’s FY24 Budget and Oversight Hearing for the Administration for Strategic Preparedness & Response (ASPR), Centers for Disease Control and Prevention (CDC), and NIH. Also invited to testify were Dawn O’Connell, Assistant Secretary of ASPR; and Rochelle Walensky, director of CDC. During the hearing, I had a chance to answer many questions and to share with the subcommittee members how NIH-supported discoveries have impacted nearly all of our lives—from research studies that lay the foundation for future biomedical advances to clinical trials that evaluate potentially lifesaving interventions. The hearing was held in the Rayburn House Office Building in Washington, D.C. Credit: NIH

Welcoming Three Members of Congress to NCI Frederick

Posted on by Lawrence Tabak, D.D.S., Ph.D.

It was a pleasure to welcome Congressional dignitaries from Maryland to NIH’s National Cancer Institute (NCI) at Frederick, MD. They took part in a roundtable discussion highlighting research at NCI Frederick in support of the Cancer Moonshot initiative. Afterwards, they visited a lab to see patient-derived models of cancer under a microscope. In this photo from the July 22 visit, I have my hand raised and standing to my left are (l-r): Senator Chris Van Hollen, Congressman David Trone, and Senator Ben Cardin. To my right is Doug Lowy, Acting NCI director. Doug and Xavier Becerra, Secretary of the U.S. Department of Health and Human Services, also greeted these Congressional leaders and helped to direct the roundtable discussion. Credit: NIH

Testifying Before House Subcommittee

Posted on by Lawrence Tabak, D.D.S., Ph.D.

A group of people with microphones sit at a long table

On May 11, I was pleased to appear before the U.S. House of Representatives Subcommittee on Labor, Health and Human Services, Education, and Related Agencies to discuss NIH’s budget request for Fiscal Year 2023. Joining me (left to right) were leaders of several NIH institutes: Nora Volkow, National Institute on Drug Abuse; Tony Fauci, National Institute of Allergy and Infectious Diseases; Diana Bianchi, Eunice Kennedy Shriver National Institute of Child Health and Human Development; Doug Lowy, National Cancer Institute; and Gary Gibbons, National Heart, Lung, and Blood Institute. 


RADx Initiative: Bioengineering for COVID-19 at Unprecedented Speed and Scale

Posted on by Bruce J. Tromberg, Ph.D., National Institute of Biomedical Imaging and Bioengineering

Credit: Africa Studio/Shutterstock; Quidel Corporation, San Diego, CA

As COVID-19 rapidly expanded throughout the world in April 2020, many in the biomedical technology community voiced significant concerns about the lack of available diagnostic tests. At that time, testing for SARS-CoV-2, the coronavirus that causes COVID-19, was conducted exclusively in clinical laboratories by order of a health-care provider. “Over the counter” (OTC) tests did not exist, and low complexity point of care (POC) platforms were rare. Fewer than 8 million tests were performed in the U.S. that month, and it was clear that we needed a radical transformation to make tests faster and more accessible.

By February 2022, driven by the Omicron variant surge, U.S. capacity had increased to a new record of more than 1.2 billion tests in a single month. Remarkably, the overwhelming majority of these—more than 85 percent—were “rapid tests” conducted in home and POC settings.

The story behind this practice-changing, “test-at-home” transformation is deeply rooted in technologic and manufacturing innovation. The NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB), working collaboratively with multiple partners across NIH, government, academia, and the private sector, has been privileged to play a leading role in this effort via the Rapid Acceleration of Diagnostics (RADx®) initiative. On this two-year anniversary of RADx, we take a brief look back at its formation, impact, and potential for future growth.

On April 24, 2020, Congress recognized that testing was an urgent national need and appropriated $1.5 billion to NIH via an emergency supplement [1]. The goal was to substantially increase the number, type, and availability of diagnostic tests in only five to six months. Since the “normal” commercialization cycle for this type of diagnostic technology is typically more than five years, we needed an entirely new approach . . . fast.

The RADx initiative was launched just five days after that challenging Congressional directive [2]. Four NIH RADx programs were eventually created to support technology development and delivery, with the goal of matching test performance with community needs [3].The first two programs, RADx Tech and RADx Advanced Technology Platforms (ATP), were developed by NIBIB and focused on innovation for rapidly creating, scaling up, and deploying new technologies.

RADx Tech is built around NIBIB’s Point of Care Technologies Research Network (POCTRN) and includes core activities for technology review, test validation, clinical studies, regulatory authorization, and test deployment. Overall, the RADx Tech network includes approximately 900 participants from government, academia, and the private sector with unique capabilities and resources designed to decrease inherent risk and guide technologies from design and development to fully disseminated commercial products.

At the core of RADx Tech operations is the “innovation funnel” rapid review process, popularized as a shark tank [4]. A total of 824 complete applications were submitted during two open calls in a four-month period, beginning April 2020 and during a one-month period in June 2021. Forty-seven projects received phase 1 funding to validate and lower the inherent risk of developing these technologies. Meanwhile, 50 companies received phase 2 contracts to support FDA authorization studies and manufacturing expansion [5]

Beyond test development, RADx Tech has evolved to become a key contributor to the U.S. COVID-19 response. The RADx Independent Test Assessment Program (ITAP) was launched in October 2021 to accelerate regulatory authorization of new tests as a joint effort with the Food and Drug Administration (FDA) [6]. The ITAP acquires analytical and clinical performance data and works closely with FDA and manufacturers to shave weeks to months off the time it normally takes to receive Emergency Use Authorization (EUA).

The RADx Tech program also created a Variant Task Force to monitor the performance of tests against each new coronavirus “variant of concern” that emerges. This helps to ensure that marketed tests continue to remain effective. Other innovative RADx Tech projects include Say Yes! Covid Test, the first online free OTC test distribution program, and Project Rosa, which conducts real-time variant tracking across the country [7].

RADx Tech, by any measure, has exceeded even the most-optimistic expectations. In two years, RADx Tech-supported companies have received 44 EUAs and added approximately 2 billion tests and test products to the U.S. capacity. These remarkable numbers have steadily increased from more than16 million tests in September 2020, just five months after the program was established [8].

RADx Tech has also made significant contributions to the distribution of 1 billion free OTC tests via the government site, COVID.gov/tests. It has also provided critical guidance on serial testing and variants that have improved test performance and changed regulatory practice [9,10]. In addition, the RADx Mobile Application Reporting System (RADx MARS) reduces barriers to test reporting and test-to-treat strategies’ The latter offers immediate treatment options via telehealth or a POC location whenever a positive test result is reported. Finally, the When to Test website provides critical guidance on when and how to test for individuals, groups, and communities.

As we look to the future, RADx Tech has enormous potential to impact the U.S. response to other pathogens, diseases, and future pandemics. Major challenges going forward include improving home tests to work as well as lab platforms and building digital health networks for capturing and reporting test results to public health officials [11].

A recent editorial published in the journal Nature Biotechnology noted, “RADx has spawned a phalanx of diagnostic products to market in just 12 months. Its long-term impact on point of care, at-home, and population testing may be even more profound [12].” We are now poised to advance a new wave of precision medicine that’s led by innovative diagnostic technologies. It represents a unique opportunity to emerge stronger from the pandemic and achieve long-term impact.

References:

[1] Public Law 116 -139—Paycheck Protection Program and Health Care Enhancement Act.

[2] NIH mobilizes national innovation initiative for COVID-19 diagnostics, NIH news release, April 29, 2020.

[3] Rapid scaling up of Covid-19 diagnostic testing in the United States—The NIH RADx Initiative. Tromberg BJ, Schwetz TA, Pérez-Stable EJ, Hodes RJ, Woychik RP, Bright RA, Fleurence RL, Collins FS. N Engl J Med. 2020 Sep 10;383(11):1071-1077.

[4] We need more covid-19 tests. We propose a ‘shark tank’ to get us there. Alexander L. and Blunt R., Washington Post, April 20, 2020.

[5] RADx® Tech/ATP dashboard, National Institute of Biomedical Imaging and Bioengineering, NIH.

[6] New HHS actions add to Biden Administration efforts to increase access to easy-to-use over-the-counter COVID-19 tests. U.S. Department of Health and Human Services Press Office, October 25, 2021.

[7] A method for variant agnostic detection of SARS-CoV-2, rapid monitoring of circulating variants, detection of mutations of biological significance, and early detection of emergent variants such as Omicron. Lai E, et al. medRxiV preprint, January 9, 2022.

[8] RADx® Tech/ATP dashboard.

[9] Longitudinal assessment of diagnostic test performance over the course of acute SARS-CoV-2 infection. Smith RL, et al. J Infect Dis. 2021 Sep 17;224(6):976-982.

[10] Comparison of rapid antigen tests’ performance between Delta (B.1.61.7; AY.X) and Omicron (B.1.1.529; BA1) variants of SARS-CoV-2: Secondary analysis from a serial home self-testing study. Soni A, et al. MedRxiv preprint, March 2, 2022.

[11] Reporting COVID-19 self-test results: The next frontier. Health Affairs, Juluru K., et al. Health Affairs, February 11, 2022.

[12] Radical solutions. Nat Biotechnol. 2021 Apr;39(4):391.

Links:

Get Free At-Home COVID Tests (COVID.gov)

When to Test (Consortia for Improving Medicine with Innovation & Technology, Boston)

Say Yes! COVID Test

RADx Programs (NIH)

RADx® Tech and ATP Programs (National Institute of Biomedical Imaging and Biomedical Engineering/NIH)

Independent Test Assessment Program (NIBIB)

Mobile Application Reporting through Standards (NIBIB)

Point-of-Care Technologies Research Network (POCTRN) (NIBIB)

[Note: Acting NIH Director Lawrence Tabak has asked the heads of NIH’s Institutes and Centers (ICs) to contribute occasional guest posts to the blog to highlight some of the interesting science that they support and conduct. This is the eighth in the series of NIH IC guest posts that will run until a new permanent NIH director is in place.]


Black Maternal Health Caucus Roundtable

Posted on by Dr. Francis Collins

Black Maternal Health Caucus Event
On December 11, 2019, the Black Maternal Health Caucus hosted a special roundtable to discuss NIH’s efforts to address the rising rates of women, especially African American women, dying in the U. S. from preventable, pregnancy-related complications. The Black Maternal Health Caucus was launched this year to raise awareness within Congress about this important women’s health issue. Before the roundtable, I gathered with some of the participants. Standing next to me (from l-r) are: Diana Bianchi, director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development; Congresswoman Alma Adams of North Carolina, a co-founder of the Caucus; Eliseo Pérez-Stable, director of NIH’s National Institute on Minority Health and Health Disparities; Congresswoman Lauren Underwood of Illinois, also a co-founder of the Caucus; and Gary Gibbons, director of NIH’s National Heart, Lung, and Blood Institute. The roundtable was held in the Longworth House Office Building, Washington, D.C. Credit: Lauren Underwood’s Office.

Meeting with Congressman Flores

Posted on by Dr. Francis Collins

Representative Flores Visit
I enjoyed spending time with Congressman Bill Flores of Texas (left) during his tour of NIH on September 17, 2019. Here, we talk in the lobby of the NIH Clinical Center with Jim Gilman (right), chief executive officer of the NIH Clinical Center. Credit: NIH.

Meeting with Freshmen Members of Congress on Addiction

Posted on by Dr. Francis Collins

Meeting with Freshmen Working Group on Addiction
I enjoyed meeting with seven members of the Freshmen Working Group on Addiction, a bipartisan group of newly elected members of the House of Representatives. They toured NIH on September 9, 2019 and sat down with me and other staff to discuss the HEAL Initiative and other efforts to defeat the opioid crisis. Among those visiting were Congresswoman Donna Shalala of Florida (left), former secretary of the Department of Health and Human Services; and Congressman Conor Lamb of Pennsylvania (middle). Also visiting were Congressman David Trone of Michigan, Congressman David Joyce of Pennsylvania, Congresswoman Susie Lee of Nevada, Congressman T.J. Cox of California, and Congresswoman Katie Hill of California. Credit: NIH

Meeting with Congressional Cancer Survivors Caucus

Posted on by Dr. Francis Collins

Congressional Cancer Survivors Causus
On July 18, 2019, I had the pleasure to meet with some of the esteemed members of the Congressional Cancer Survivors Caucus during their visit to NIH. Here, I paused for a photo with (l-r) Congressman Earl “Buddy” Carter of Georgia, caucus co-chair; Jennie Lucca, chief executive officer of The Children’s Inn at NIH; Laura King, senior director of community engagement at The Children’s Inn; and Congressman Mark DeSaulner of California, a caucus co-founder and a leukemia survivor. The Congressional Cancer Survivors Caucus is a bipartisan group for members of Congress to discuss issues related to cancer diagnosis, treatment, and survivorship with a variety of stakeholders and experts. Credit: NIH.

Testifying Before House Subcommittee

Posted on by Dr. Francis Collins

On April 2, 2019, I testified before the House Labor/HHS Appropriations Subcommittee on NIH’s budget for Fiscal Year 2020. Here I am waiting for the hearing to start with my colleagues (left to right) Gary Gibbons, director of the National Heart, Lung, and Blood Institute; Diana Bianchi, director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development; and Anthony Fauci, director of National Institute of Allergy and Infectious Diseases. Credit: NIH