September 9 2921 – AdvaMed, the world’s leading trade association for medical technology companies—which includes the diagnostics companies that make Covid-19 tests—released the following statement from president and CEO Scott Whitaker:
“We applaud the President and his Administration for recognizing the critical roles regular testing and widespread vaccination serve in bringing the pandemic under control. We look forward to continuing to work closely with the Administration to further extend the reach of quality testing, strengthening our public-private collaboration and coordination. Our diagnostic companies, as they have been from the beginning of this crisis, are fully committed to supporting our nation’s Covid response. Our industry has been leading the way, to ensure our employees and contractors are either vaccinated or regularly tested. It’s critically important to keep facilities open and ensure they remain as safe as possible so that the important work of manufacturing the medical technologies patients rely on can continue.”
Last week, AdvaMedDx – the division within AdvaMed that serves diagnostics manufacturers – sent <<a letter>> with the American Clinical Laboratory Association (ACLA) to the White House offering a number of policy recommendations to help the diagnostic testing industry continue to meet the challenges presented by the pandemic. The recommendations included:
- Robust expansion of specimen collection/testing sites. The shift of testing sites to mass vaccination centers drove access to critically needed vaccinations. However, reopening sample collection/testing sites is necessary to leverage the laboratory capacity available to increase testing, particularly in the two dozen states with over ten percent positivity during this surge.
- Formalized and permanent forum for frequent, real time and meaningful communication and collaboration between the Administration and the diagnostics manufacturers and laboratories driving access to testing.
- Development and communication of forward looking policy and insurance of testing availability for whatever may come, based on pandemic modeling, to strategize how commercial labs and manufacturers can best support the nation’s testing needs.
- Maintain and bolster testing capacity by fully leveraging mechanisms such as the Strategic National Stockpile and agreements with diagnostics manufacturers like vendor managed inventory and warm-base contracting. Ensure CDC directly contracts with high complexity laboratories to retain and reserve personnel, equipment, test supplies and facilities necessary to quickly bring new tests and substantial capacity online when called upon to respond to an emerging pathogen threat. Strengthening public-private preparedness collaboration with the CDC and private sector laboratories and diagnostics manufacturers is critical to ensure up to date diagnostics are available and rapidly deployed, and laboratory capacity is maintained.
- Comprehensive, consistent information to states about testing, emphasizing fully leveraging all high- quality molecular, antigen, serology, and T-cell tests across laboratory, point-of-care and over-the- counter modalities is necessary to extend the reach of testing. Strategies such as pooling should be utilized, as appropriate, and tools such as wastewater surveillance testing should be employed.
- Significantly augment and make public CDC’s epidemiological studies using serology/antibody testing to understand the pervasiveness of the impact of COVID for all communities, while improving our collective understanding of correlative immunity as we prepare for broader administration of vaccine boosters.
- Allow states flexibility to modify testing plans, fully supported by American Rescue Plan funding as the need arises.
- Continued extension of public health emergency (PHE), allowing maintenance of reimbursement levels that have allowed labs to procure instrumentation and supplies, and maintain capacity.
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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.
