By Deborah Borfitz
April 9, 2020 | Three types of COVID-19 tests—symptomatic molecular testing, asymptomatic screening and next generation sequencing (NGS)—are critical to bringing a semblance of normalcy to the lives of employed Americans that includes a safe return to the workplace, according to a framework newly drafted by the Policy and Reimbursement Working Group of BloodPAC. The testing approach, they say, is designed to “locate the earliest signs of the virus across the general population, treat with the best available approaches, and direct behavior on quarantining/reintegrating people into the workforce.”
BloodPAC is a consortium managed by the nonprofit Center for Computational Science Research, Inc. The working group comprises participants from Bristol-Myers Squibb, Center for Medical Technology Policy Inc., Eli Lilly and Company, Epic Sciences, Foundation Medicine, Inc., Illumina, Lexent Bio, LGC Group, Open Commons Consortium, Sysmex Inostics, Thermo Fisher Scientific, University of Chicago and University of Southern California.
For symptomatic diagnosis and patient triage, including all frontline workers, polymerase chain reaction (PCR) and point-of-care (POC) testing have already been granted emergency use authorization by the U.S. Food and Drug Administration (FDA), the authors note. Roche, Thermo Fisher Scientific and Luminex are among those producing PCR tests, and Cepheid and Abbott are ramping up manufacturing of their POC tests.
General population serology/antibody tests are under development by Healgen Scientific, Biomerica and Sugentech and don’t require an active infection to acquire results. Their widespread deployment in the asymptomatic population “could be the tipping point for informing the public of herd immunity thresholds and when it’s safe to return to work,” the document states.
COVID-19 NGS can accurately identify the “source code” of the virus and track its evolution as it spreads throughout the population, they continue. This will inform transmission routes and ensure the efficacy of current diagnostic tests and vaccine strategies as the virus mutates. NGS combined with global databases, such as Global Initiative on Sharing All Influenza Data (GISAID) or National Center for Biotechnology Information (NCBI), would enable real-time pathogen genomics.
NGS testing is being done at academic medical centers, public health laboratories and clinical reference labs and results are possible in as few as two to five days. Among the testing manufacturers are Illumina and Thermo Fisher Scientific.
The Challenges
Each test type comes with its own unique set of challenges, according to the framework.
PCR and POC tests face supply chain delays due to issues of availability and turnaround times that often exceed a week. Shortages of collection mechanisms (nasal swabs) and testing supplies (reagents) is also a problem. Sick individuals who lack a practical way to access testing and care spread the virus.
With serology screening tests, the framework states, the challenges are understanding who has been previously infected with COVID-19 and how much of the population has been infected. The tests under development have variable sensitivities and specificities; no gold-standard method exists to confirm positive results. Policies and regulations of the FDA and the Center for Medicare & Medicaid Services also have not streamlined the launch of antibody tests nor established reimbursement or test frequencies.
Development of a comprehensive NGS network would require standardized protocols for COVID-19 sequencing and uploading of data into global databases for analysis, according to the document. It also necessitates open data-sharing strategies to inform public health interventions as well as long-term funding to ensure real-time decision-making is maintained throughout the current outbreak—and beyond to include multidrug-resistant organisms, emerging viruses and pathogens with bioterrorism potential.
Editor’s note: The framework was published last week in Medium, and a related commentary based on discussions with BloodPAC leaders ran in the Wall Street Journal.