publication date: Jun. 19, 2020
FDA joins Reagan-Udall, Friends of Cancer Research to form COVID-19 Diagnostics Evidence Accelerator
FDA is participating in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics. The accelerator is organized by the Reagan-Udall Foundation for FDA in collaboration with Friends of Cancer Research.
“While there are current studies of viral diagnostic and antibody tests using traditional assessment methods, the Diagnostics Evidence Accelerator will allow the community to analyze both diagnostic and clinical data in real time, which has the potential to contribute to the scientific evaluation of diagnostic tools and medical interventions for COVID-19,” Amy Abernethy, FDA principal deputy commissioner, said in a statement. “FDA’s participation in the Diagnostics Evidence Accelerator is another example of how we are working with a broad set of experts in healthcare data and analytics to understand the performance of SARS-CoV-2 tests and to inform clinical and public health decision-making.”
The Diagnostics Evidence Accelerator is the companion project to the previously announced Therapeutic Evidence Accelerator, which brings together leading experts in health data aggregation and analytics in a unified, collaborative effort to share insights, compare results and answer key questions to inform the collective COVID-19 response.
“This collaboration with the FDA, scientists and data experts is meeting the urgency of the moment to speed the pace of diagnostic testing,” Ellen V. Sigal, chair of both the Reagan-Udall Foundation and Friends of Cancer Research, said in a statement. “We all share the goal of deepening our understanding of COVID-19 on every front to ensure that patients receive the best care as quickly and safely as possible.”
Research questions that will be examined through the Diagnostics Evidence Accelerator include evaluating the real-world performance of SARS-CoV-2 diagnostic tests and antibody tests, how they are best used to tailor testing strategies to specific populations, and what test results and data may reveal about the prevalence of disease, chains of transmission, and individual and population-level immunity.
The effort will focus on how real-world data can help understand whether the presence of antibodies can indicate future immunity and if so, which specific antibodies and epitopes contribute to some level of protection against future infection.
Using real-world data can also provide actionable information about the prevalence of SARS-CoV-2 in specific populations and highlight individual risk factors for patients, helping to improve our understanding of the disease, tailor public health interventions and strategies to mitigate risks for individuals and communities, and help stop the spread of SARS-CoV-2. The evidence generated through the Diagnostics Accelerator is intended to be complementary to other studies that have been conducted or are underway as well as to address questions not yet answered.
“We recognize that questions related to the accuracy of diagnostic tests require different data elements that are not as widely available as those in the therapeutic space. They also require a different approach to data integration and analysis,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health. “The aim of the accelerator is to propose questions, refine them, evaluate the feasibility of different approaches, and bring together groups that have the data to answer the questions and develop lasting solutions. Ultimately, we hope that real-world data can provide a more generalizable and rapid read-out of results than traditional clinical trials.”
The Diagnostics Evidence Accelerator represents the type of data-focused effort that has the potential to inform our future emergency efforts. In an emergency setting, the FDA may issue emergency use authorizations (EUAs) which are evaluated using a different standard than is required for approval or clearance in non-emergency situations. Gaining a better understanding of the real-world performance characteristics of diagnostic tests and antibody tests can help inform future EUAs.
Research!America seeks $26 billion boost to NIH, CDC, FDA funding in FY21
In a letter to House and Senate leaders, Research!America has asked for a massive boost in federal spending to address the damage the U.S. research organizations have sustained as a result of the COVID-19 pandemic.
”Funding of $26 billion is the minimum needed to re-seed the U.S. R&D continuum across all federal research funding, and to address gaps in voluntary health organization and philanthropic research funding resulting from the pandemic,” Mary Woolley, president and CEO of Research!America, writes in the letter. “NIH Director Francis Collins has indicated that NIH alone needs $10 billion to address erosion in grant dollars.”
The text of the letter follows:
Dear Leader McConnell, Speaker Pelosi, Minority Leader Schumer, and Minority Leader McCarthy:
We greatly appreciate your continued bipartisan commitment to responding resolutely and responsibly to the COVID-19 pandemic. Among the extreme impacts of COVID-19 is the destabilizing and stultifying effect on progress against the plethora of other deadly and debilitating diseases that threaten Americans and populations across the globe. We are writing to urge you to coalesce around two actions to empower desperately needed, lifesaving progress.
First, we ask that you provide the funding needed to restart research stalled or reprogrammed as a result of the pandemic. NIH Director Francis Collins has indicated that NIH alone needs $10 billion to address erosion in grant dollars. Funding of $26 billion is the minimum needed to re-seed the U.S. R&D continuum across all federal research funding, and to address gaps in voluntary health organization and philanthropic research funding resulting from the pandemic.
Second, we ask that you craft Fiscal Year 2021 appropriations in a way that accommodates unanticipated, but critically important, pandemic and VA funding needs while continuing to advance other top American priorities. The current budget caps were established before COVID-19 altered virtually every facet of American life. The pandemic did not, however, alter the importance of such enduring priorities as meeting the needs of our nation’s veterans and speeding progress against cancer, Alzheimer’s, and other destructive health threats. We ask that you exempt funding for the VA MISSION Act and pandemic-related spending from the budget caps to enable robust growth in the annual budgets of NIH, CDC, FDA, AHRQ and other research agencies critical to medical and public health progress.
We appreciate your consideration of these two pivotally important actions. Thank you, and please express our gratitude to your respective staff members, for your exceptionally hard work on behalf of the American people.
Algorithm helps select breast cancer patients for urgent surgery or chemotherapy during pandemic
Researchers in the U.K, Germany and the United States have developed an algorithm to better select breast cancer patients in need of urgent surgery or chemotherapy during the COVID-19 pandemic.
The algorithm, using data from multiple international trials, can identify postmenopausal patients with primary ER+HER2- breast cancer who have either less endocrine-sensitive tumors and who should be prioritized for early surgery or neoadjuvant chemotherapy, or an endocrine-sensitive tumor that can be treated for up to 6 months with an endocrine drug with a safe surgical delay.
While patients diagnosed with triple negative breast and HER2-positive cancer have still been going forward for urgent surgery or chemotherapy, it is safe for a large group of patients to defer these treatments and treat with neoadjuvant endocrine therapy instead. Researchers have identified this method to reduce the stimulation of the disease by estrogen without the surgical removal of the breast tumour as the best course of treatment.
Matthew Ellis, professor and director of the Lester and Sue Breast Center at Baylor College of Medicine, was a key collaborator on the study published in NPJ Breast Cancer. The work highlighted that while 85% of patients can defer surgery and are safe to remain on NeoET treatment for up to 6 months, 15% of patients are resistant to this treatment and risk disease spread and tumor progression with delayed surgery. Ellis led the Alliance for Clinical Trials in Oncology Z1031 study that provided key data.
“NeoET jumped from being an esoteric, occasionally used option to the predominant standard of care within one month of the COVID-19 epidemic curtailing surgical access,” Ellis, a McNair Scholar and Susan G. Komen Scholar at Baylor, said in a statement. “We wanted to be sure that those unfamiliar with the approach could have a data-driven algorithm to apply so this useful approach could be used wisely.”
“By accessing unpublished results from clinical trials involving thousands of patients, we have developed a new way of directing patient treatment in this global crisis,” Mitch Dowsett, professor and head of the Ralph Lauren Centre for Breast Cancer Research at the Royal Marsden in London, and corresponding author of the study, said in a statement. “Using the data on tumor estrogen receptor, progesterone receptor and proliferation status in newly diagnosed patients, our simple calculator can be used by fellow clinicians worldwide to immediately identify the best course of treatment for about 80% of their patients.”
Researchers also found that they could identify women who were at risk for loss of disease control by measuring Ki67, a protein that measures the number of cells dividing in the tumor, a few weeks after the start of NeoET. Those women, about 20% of the patients, were recommended surgery or neoadjuvant chemotherapy.
FDA issues warning letters to companies marketing antibody tests
FDA has issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests.
Generally, antibody tests, also called serological tests, detect antibodies to SARS-CoV-2, which can help identify individuals who have developed an adaptive immune response to the virus, as part of either an active infection or a prior infection. These tests may be important in the fight against this pandemic, as they may provide information on disease prevalence and the frequency of asymptomatic infection. Today’s warning letters are the first set of letters the agency has issued for marketing adulterated or misbranded COVID-19 test kits.
“Providing regulatory flexibility during this public health emergency never meant we would allow fraud,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement. “When tests are marketed inappropriately, with inaccurate or misleading claims – such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not – they put the health of Americans at risk. Such conduct will not be tolerated by the FDA, and we will continue to monitor tests marketed in the U.S., taking appropriate action as warranted.”
Warning letters were issued to: Medakit Ltd. of Sheung Wan, Hong Kong; Antibodiescheck.com and Yama Group; and Dr. Jason Korkus, DDS and Sonrisa Family Dental d/b/a My COVID19 Club of Chicago, Illinois. Violations outlined in the warning letters include: offering test kits for sale in the United States directly to consumers for at-home use without marketing approval, clearance, or authorization from the FDA; misbranding products with labeling that falsely claims products are “FDA approved”; and labeling that bears the FDA logo, which is only for the official use by the FDA and not for use on private sector materials.
There are no diagnostic or antibody COVID-19 test kits that are authorized, cleared or approved to be used completely at home. Testing in the home can present unique and potentially serious public health risks, including whether a lay user has the ability to collect their specimen, run the test, and interpret their results accurately. However, the FDA has authorized several diagnostic COVID-19 tests for use with at-home collection of samples—such as from the nose or saliva—that can then be sent to a lab for processing and test reporting. However, there are not any serology tests that are authorized for use with at-home collection of samples.
The FDA has requested that the companies take immediate steps to correct violations, such as ceasing the sale of the products or preventing future sales. Failure to immediately correct the violations cited in the warning letters may result in legal action, including possible seizure and injunction.
The FDA reminds consumers to be cautious of websites and stores selling products, including test kits, that claim to prevent, mitigate, treat, diagnose or cure COVID-19. Fraudulent COVID-19 products defraud consumers of money and can place consumers at risk for serious harm. Using these products may lead to delays in getting proper diagnosis and treatment of COVID-19 and other potentially serious diseases and conditions.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of COVID-19 products to the FDA’s MedWatch Adverse Event Reporting program.
TERAVOLT registry tracks outcomes of treatments among thoracic cancer patients with COVID-19
New data from TERAVOLT, a global consortium that tracks outcomes of people with thoracic cancers affected by COVID-19, could demonstrate why thoracic cancer patients experienced a high death rate of 33% when COVID-19 swept across Europe.
While the majority of those who died were hospitalized, only 9% were admitted to intensive care units, according to a study published June 12 in The Lancet Oncology. Most died from complications of COVID-19, not the progression of cancer.
“Just having a lung cancer diagnosis in and of itself shouldn’t exclude patients from care,” senior author Leora Horn, Ingram Associate Professor of Cancer Research at Vanderbilt-Ingram Cancer Center and TERAVOLT consortium steering committee member, said in a statement.
The study is based on the first 200 patients for whom TERAVOLT received outcomes data. Of the 152 hospitalized patients, 134, or 88%, met the criteria for ICU admission, but only 13 of those patients were admitted to an ICU. Only five were mechanically ventilated.
Most of the patients were hospitalized in Italy, France and Spain. The study’s lead author, Marina Garassino, of the National Cancer Institute of Milan, initiated the idea for the registry, which led to the TERAVOLT consortium (Thoracic cancERs InterAtional coVid 19 cOLlobaraTion).
“We tried to capture the reasons for the lack of ICU admission,” the authors noted in the study. “Difficult decisions were made limiting ICU admissions to cancer patients and others with terminal illness due to equipment and personnel shortages. However, we are aware that behind these choices there may also be patients’ decisions, cultural and institutional choices that our work is unable to properly capture.”
“Not all lung cancer patients are at risk for hospitalization,” Horn said.
Initial data indicated that patients on tyrosine kinase inhibitors appeared to be at decreased risk for hospital admission. This remained true when Horn presented updated data from the TERAVOLT registry last month at the virtual annual meeting of the American Society of Clinical Oncology. The data presented at the ASCO meeting were based on those first 200 patients in The Lancet Oncology study, plus an additional 200, including many from the United States.
That data revealed that patients treated with chemotherapy within three months of a COVID-19 diagnosis had a significantly increased risk—64%—of dying from the coronavirus. Patients treated with anticoagulants to prevent blood clots and corticosteroids to reduce inflammation also had a greater mortality risk. Patients treated with immunotherapies had no increased risk of mortality.
It remains unclear if intubation and more aggressive care could improve survival for people with thoracic cancers sickened by COVID-19. Patients preferences could provide guidance for clinicians.
The TERAVOLT registry is an ongoing longitudinal study. Data collected from consortium participants across the globe are entered on a REDCap database hosted by Vanderbilt. The registry recently received $95,000 in funding support from the International Association for the Study of Lung Cancer on behalf of the Lung Ambition Alliance.
Immunotherapy clinical trial for COVID-19 open at Mount Sinai
Mount Sinai Health System is beginning the first clinical trial in the New York metropolitan region of an immune-boosting therapy in COVID-19 patients.
The phase II randomized trial is expected to recruit 66 patients to study peginterferon lambda in hospitalized patients receiving supplemental oxygen. Peginterferon lambda is injected under the skin as a single, one-time dose, and scientists believe it can help the immune system control the virus infection, decreasing the duration and severity of COVID-19.
“There is significant evidence from laboratory studies done here at Mount Sinai and abroad that patients’ own immune systems are making inadequate amounts of interferon lambda—an alert signal the lungs normally send out to the immune system that a virus is present—when patients are infected with the coronavirus causing COVID-19,” principal investigator Thomas Marron, assistant director of Early Phase and Immunotherapy Clinical Trials at The Tisch Cancer Institute at Mount Sinai, said in a statement. “As naturally occurring interferon lambda is the first line of defense against COVID-19, we have designed a clinical trial that will quickly determine whether treatment with peginterferon lambda will decrease the severity of COVID-19.”
Scientists at Mount Sinai knew about peginterferon lambda from phase III trials for viral hepatitis and felt its antiviral properties would be beneficial to COVID-19 patients based on studies in mouse models. Scott Friedman, dean for Therapeutic Discovery at the Icahn School of Medicine at Mount Sinai, sought out the maker of the therapy, Eiger Biopharmaceuticals.
Together with Eiger, Friedman also sought funding from the COVID-19 Early Treatment Fund started by Silicon Valley entrepreneur and philanthropist Steve Kirsch, who in turn found matching funds from donors that include Corrigan Walla Foundation and David Baszucki, the founder and CEO of Roblox Corporation, and his wife, author Jan Ellison Baszucki. The total monetary donation was $500,000, and Eiger Biopharmaceuticals donated the drug for the trial.
Other sites are testing peginterferon lambda’s effectiveness prophylactically and in outpatients with mild COVID-19 cases. Mount Sinai’s Human Immune Monitoring Center, led by Miriam Merad, director of the Precision Immunology Institute at the Icahn School of Medicine at Mount Sinai, will perform extensive analysis of patients’ blood to characterize the response to the peginterferon lambda, and help determine if it is effective in activating the immune system to attack the coronavirus.