Newsletter Contents
Latest News and Updates:
- American Rescue Plan Includes Significant Support for COVID-19 Testing
- Biden Administration Announcements Re: COVID-19 Testing in K-8 Schools
- FDA Guidance on COVID-19 Variants' Impact on Testing; AdvaMedDx Members Focus on Variants
- COVID Test Coverage Improvements
- AdvaMed COVID-19 Supply Registry: Molecular Shipments reach ~405 Million
- AdvaMedDx Hosts Session with Johns Hopkins Center for Public Health Security on the JHU COVID-19 Testing Toolkit
- AdvaMedDx-Genetic Alliance Host Congressional Briefing on Precision Medicine Diagnostics
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April 13: AdvaMedDx – World Health Organization Session on Pandemic Influenza Preparedness
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All Upcoming AdvaMedDx Member Events
1. American Rescue Plan Includes Significant Support for COVID-19 Testing
President Biden has signed into law the $1.9 trillion stimulus package, The American Rescue Plan (ARP). ARP recognizes the critical role COVID-19 testing continues to service in our collective response to the pandemic. Key testing-related provisions therein are:
$500 Million in funding for COVID-19 vaccine, therapeutic, and device activities at the FDA: Section 2304 provides $500 million to the Food and Drug Administration (FDA) for the evaluation of the continued performance, safety and effectiveness—including with respect to emerging variants—of vaccines, therapeutics, and diagnostics approved, cleared, licensed, or authorized for treatment, prevention, or diagnosis of COVID-19, as well as for inspections and oversight of the supply chain.
$47.8 Billion in funding for COVID-19 testing, contact tracing, and mitigation activities: Section 2401 provides $47.8 billion to the Department of Health and Human Services (HHS) to carry out activities to detect, diagnose, trace, and monitor COVID-19 infections and related strategies to mitigate the spread. The wide-reaching provision indicates the Secretary shall leverage the funding to support the development, manufacturing, procurement, distribution, and administration of tests to detect or diagnose COVID-19, including by supporting the development, manufacture, procurement, and distribution of supplies necessary for administering tests, and by supporting the acquisition, construction, alteration, or renovation of non-federally owned facilities for the production of diagnostics and ancillary medical products and supplies.
$1.75 billion in funding for SARS-CoV-2 genomic sequencing and surveillance: Section 2402 provides $1.75 billion to the HHS to strengthen and expand activities and workforce related to genomic sequencing, analytics, and disease surveillance, led by the Centers for Disease Control and Prevention.
$10 Billion in funding for COVID-19 emergency medical supplies enhancement: Section 3101 provides $10 billion to remain available until September 30, 2025, to carry out titles I, III, and VII of the Defense Production Act for the purchase, production, or distribution of medical supplies and equipment related to combating the COVID-19 pandemic, including in vitro diagnostic products.
Contact: Susan Van Meter
2. Biden Administration Announcements Re: COVID-19 Testing in K-8 Schools
In alignment with the Biden-Harris National Strategy for COVID-19 Response and Pandemic Preparedness, the Administration has taken several major steps towards the goal of supporting in-person learning in K-8 schools by extending the reach of COVID-19 testing for screening to students, faculty and staff of these schools. These announcements include:
HHS and the Department of Defense Issue $650 million solicitation for K-8 testing
On March 8th, the Department of Health and Human Services issued a Request for Proposals (RFP) to extend the Reach of COVID-19 testing to K-8 schools and underserved populations (congregate settings, such as homeless shelters) by leveraging large universities and commercial laboratories to collect specimens, perform tests and report results to the relevant public health agencies. The Administration aims to secure 4 Regional Coordinating Centers to each connect with about 10 laboratories, working with states and K-8 schools and congregate settings in their region to coordinate end-to-end testing programs. This 6-month contract is expected to increase testing by 25 million per month. Awards will be announced April 27.
FDA releases update on the EUA pathway for test developers seeking a serial testing screening claim
On March 16th, the FDA provided new recommendations and information for test developers to streamline the path to emergency use authorization (EUA) for screening tests with serial testing. FDA describes a new EUA template thusly: “This template is intended to provide supplemental recommendations for developers of molecular and antigen tests seeking claims for screening with serial testing without studying asymptomatic individuals prior to authorization, including for point-of-care (POC) and at-home tests.”
FDA also has released a fact sheet to assist schools, workplaces, communities, and others looking to establish testing programs to screen asymptomatic individuals as they are selecting a test for screening.
CDC updates guidance for schools, highlights the value of screening in K-12 schools
CDC released updated testing guidance to provide recommendations for how to use screening testing to identify, track, and mitigate asymptomatic transmission of COVID-19. The guidance provides information on the categories of tests used to detect COVID-19 and the intended strategies for use of those tests, including to diagnose infection, to screen to reduce asymptomatic or pre-symptomatic transmission, and to monitor trends in infection.
HHS Announces $10 Billion for Screening Testing for K-8, Leveraging the American Rescue Plan
On March 17th, the Administration made its first major investment for testing and testing services pursuant to passage of the American Rescue Plan, announcing the Centers for Disease Control and Prevention (CDC) will invest $10 billion in states’ efforts to bolster or establish testing programs for K-8 schools, while also updating its key guidance to schools to encourage screening programs. The program recognizes the value of both laboratory-based and point-of-care molecular and antigen tests for screening of asymptomatic individuals.
Contact: Susan Van Meter
3. FDA Guidance on COVID-19 Variants' Impact on Testing; AdvaMedDx Members Focus on Variants
As anticipated, FDA has released guidance outlining expectations for evaluation of the impact of virus variants on all types of COVID-19 tests, including serology, antigen and molecular tests. The guidance went into effect immediately; however, there is an opportunity to provide feedback. The guidance was released as part of a suite of documents from FDA regarding assessment of virus variants.
For all modalities, for tests already authorized under EUA, FDA expects monitoring and potentially labeling about variants. For tests under development, FDA is considering to include evaluation of possible variants as a condition of authorization upon future authorization.
FDA provided more detailed recommendations for molecular tests than it did for serology or antigen tests. At a high-level, FDA recommends that developers of molecular tests: 1) design their test to minimize the impact of viral mutations on test performance (and provides recommendations on the selection of molecular targets likely to withstand issues from variants); 2) routinely monitor for viral mutations that may impact test performance; and 3) clearly convey any test limitations in the test’s labeling.
AdvaMedDx member focus on variants
AdvaMedDx members strive to design their tests in a manner that can withstand variants and are committed to monitoring the impact of virus variants on their COVID-19 tests. AdvaMedDx member companies with diagnostics tests for viruses, including COVID-19, routinely and frequently assess the impact of significant variants on the effectiveness of their tests. For example, the seasonal flu virus mutates rapidly, and companies evaluate their tests, and adjust if needed, to reflect these changes in the virus. AdvaMedDx members anticipate virus mutations and when designing tests strive to target multiple areas of the viral genome, focusing on those sites that are least likely to mutate. IVD manufacturers with molecular, antigen and serology tests for COVID-19 are committed to monitoring the impact of viral variants on test results obtained by their assays. This includes frequent and comprehensive examination of sequencing analyses of all COVID-19 variants in publicly available databases.
Diagnostic tests for use during the public health emergency are granted authorization subject to conditions. For COVID-19 tests, a test developer has an obligation to collect test performance information to monitor and report to FDA false results and significant deviations in performance. For instance, in the context of serology tests, FDA has stated that it believes a reduction in sensitivity will undermine the test performance, if it goes below 95 percent; a reduction that is less would not. If the manufacturer determines that the reduction in sensitivity would compromise the test performance, then they are required to take appropriate action, including possibly adjusting the test and/or reporting to FDA.
AdvaMedDx and our members are engaging with FDA and CDC as they develop plans to assess the continued effectiveness of COVID-19 tests, given the emergence of the variants of significance. We are working to develop comments to the guidance, leveraging recommendations already provided by members.
Contact: Jamie Wolszon
4. COVID Test Coverage Improvements
On March 2nd, 2021 the Biden Administration issued an updated policy on health plan requirements for the coverage of COVID-19 tests. The new policy improves coverage by clearly stating plans must cover asymptomatic testing for individuals (both lab-based and point-of-care). AdvaMedDx, in coalition with our laboratory partners, has advocated that coverage holes be closed. More details are included below.
On the same date, the Biden Administration also issued an updated Frequently Asked Questions (FAQs) addressing coverage of COVID-19 testing, as well as vaccine and vaccine administration coverage. These FAQs were issued jointly by the Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments). This Tri-Agency announcement clarifies earlier versions of FAQs released in 2020 by the Departments. The FAQs respond to questions arising from implementation of the Families First Coronavirus Relief Act (FFCRA), enacted on March 18, 2020, and subsequently amended by the Coronavirus Aid, Relief, and Economic Security (CARES) Act on March 27, 2020. The FAQs have been updated several times since they were originally issued. Specific mentions in the FAQ are listed below.
Asymptomatic Testing: Importantly, the FAQs clarifies that for individuals, health plans cannot deny coverage of COVID-19 diagnostic testing for asymptomatic individuals without known or suspected exposure to COVID-19.
Employer Testing: The FAQ does indicate that plans and issuers may “distinguish between COVID-19 diagnostic testing of asymptomatic people that must be covered, and testing for general workplace health and safety, for public health surveillance, or for other purposes not primarily intended for individualized diagnosis or treatment of COVID-19.” The FAQ continues that plans may provide coverage of testing for general workplace /public health surveillance but are not required to do so. Consultation with stakeholder colleagues suggests this provision could be interpreted to support coverage of workplace testing when performed primarily for individualized diagnosis or treatment of COVID-19.
Point-of-care Testing: The FAQs also clarify that point-of-care COVID-19 tests must be covered without cost-sharing and note that the FFCRA and CARES Act do not distinguish between point-of-care and other tests; all COVID-19 diagnostic tests that meet one of the criteria outlined in the law must be covered without cost sharing, prior authorization, or medical management.
Defining diagnostic testing: In a prior version of the FAQ, serology testing was subsumed under “diagnostic” test. (see “Q4” note below from the April 11, 2020 FAQ update)
Q4. Do “in vitro diagnostic tests” described in section 6001(a)(1) of the FFCRA, as amended by section 3201 of the CARES Act, include serological tests for COVID-19? Yes. Serological tests for COVID-19 are used to detect antibodies against the SARS-CoV-2 virus and are intended for use in the diagnosis of the disease or condition of having current or past infection with SARS-CoV-2, the virus which causes COVID-19. The Food and Drug Administration (FDA) currently believes such tests should not be used as the sole basis for diagnosis.13 FDA has advised the Departments that serological tests for COVID-19 meet the definition of an in vitro diagnostic product for the detection of SARS-CoV-2 or the diagnosis of COVID-19.14 Therefore, plans and issuers must provide coverage for a serological test for COVID-19 that otherwise meets the requirements of section 6001(a)(1) of the FFCRA, as amended by section 3201 of the CARES Act. 15
AdvaMedDx will continue to monitor this important issue in order to better understand the impact, particularly as it relates to asymptomatic testing.
Contact: Chandra Branham
5. AdvaMed COVID-19 Supply Registry: Molecular Shipments reach 405 Million
The latest AdvaMed COVID-19 Testing Supply Registry report demonstrates that participating companies have collectively shipped 405 million molecular tests for COVID-19 nationwide to date for the week ending on March 19th. The Registry participants are Abbott, BD, bioMérieux, Bio-Rad, Beckman Coulter, Cepheid, Fujirebio, Hologic, Ortho Clinical Diagnostics, QIAGEN, Roche Diagnostics, Sekisui Diagnostics, Siemens Healthineers, and Thermo Fisher Scientific. Registry participants comprise ~80-85% of the COVID-19 Molecular IVD tests on the market in the U.S. The Registry gathers robust data on both serology and antigen testing in which it has been shown that the industry has significant manufacturing capacity for both serology and antigen testing.
View the most recent Public Release of the COVID-19 Supply Registry: Here
Contact: Susan Van Meter
6. AdvaMedDx and Johns Hopkins Center for Public Health Security: Webinar Event on COVID-19 Testing Toolkit
On March 17th, AdvaMedDx in partnership with the Johns Hopkins Center for Public Health Security (CPHS) held a webinar to discuss CPHS’s recently launched COVID-19 Testing Toolkit. CPHS, through its Coronavirus Resource Center has been providing invaluable information to public health experts, policy makers and the public throughout the pandemic. Recently, JHU has added to its COVID-19 resources a new site, the COVID-19 Testing Toolkit . The site is designed to serve as a resource for individuals and organizations to learn about testing and testing services, including COVID-19 testing service providers. During the March 17 session, John Hopkins University experts discussed their ongoing assessment of COVID-19 test service providers that are working with schools, businesses, and other entities to support COVID-19 testing.
CPHS will host a series of webinars highlighting case studies of successful COVID-19 testing programs in schools, businesses, and other settings.
Contact: Susan Van Meter
7. AdvaMedDx-Genetic Alliance Host Congressional Briefing on Precision Medicine Diagnostics
On February 25th, 2021, in recognition of Rare Disease Day, AdvaMedDx partnered with Genetic Alliance to host a briefing on precision medicine and genomic sequencing. A panel of speakers discussed Whole Genome Sequencing for pediatric rare and undiagnosed cases, specifically highlighting the successes of California’s Project Baby Bear and how the Biden administration and Congress can support similar federal efforts. Project Baby Bear is a project funded by the State of California to provide Whole Genome Sequencing (WGS) for children enrolled in Medi-Cal. Analysis showed the project resulted in faster diagnoses, better health outcomes, reduced suffering, and a decreased cost of care.
The event featured remarks from Rep. Scott Peters (D-CA 52nd District), Dr. Eric Green MD, PhD, (National Human Genome Research Institute), Dr. David Dimmock, MD (Rady Children’s Institute for Genomic Medicine), and Sharon Terry, MA (Genetic Alliance). Susan Van Meter (AdvaMedDx) moderated the session.
A video recording of the briefing can be found here.
Contact: Susan Van Meter
8. April 13: AdvaMedDx – World Health Organization Session on Pandemic Influenza Preparedness
AdvaMedDx members that develop diagnostic tests for flu are encouraged to join an April 13 session with the World Health Organization’s Pandemic Influenza Preparedness (PIP) Secretariat. During the session, the Secretariat will provide an overview of the PIP Framework and Global Influenza Strategy. Basics of the program will be addressed, including the benefits to low and middle income countries that come from support WHO receives from the vaccine, pharmaceutical and diagnostics industries that use the Global Influenza Surveillance and Response System.
AdvaMedDx members who wish to join the session should please RSVP to Sumita Bhattarai at sbhattarai@advameddx.org
Contact: Susan Van Meter
9. Upcoming Member Events
- March 25: Diagnostics Payment Work Group Meeting. Payment and Coverage experts interested in joining, please contact Chandra Branham
- March 30 and April 13: AdvaMedDx Bi-Weekly Regulatory Reform Call. Government affairs and regulatory experts interested in joining should please contact: Sarah Killeen
- March 31: AdvaMedDx Bi-Weekly Public Affairs Work Group Call. Public Affairs and government relations experts interested in joining should please contact: Sumita Bhattarai
- April 5: Dx Task Force Call on COVID-19 virus variants impact on diagnostics. Regulatory experts interested in joining should please contact: Anita Nosratieh
- April 7: AdvaMedDx Antimicrobial Resistance work group call. If interested in joining, please contact Kristina Shultz.
- April 13: Briefing with the WHO on PIP Framework and Global Influenza Strategy. Should you be interested in joining this briefing please contact Sumita Bhattarai
- April 27: AdvaMed Value Assessment Workshop: For more information on this event, please contact: Chandra Branham