Lessons From Personalized Medicine Can Supercharge Coronavirus Testing
Contributed Commentary By Mike Pellini, Vance Vanier, and Amy DuRoss
May 6, 2020 | In New Jersey, feverish patients line up overnight for a coronavirus test, and then wait days for results. In our home state of California, as well as world-wide, leaders are trying to expand testing as the first requirement of reopening daily life. Months into the Covid-19 pandemic, the United States remains dangerously behind on testing—and we know that technology from personalized medicine can help correct the chaos.
In medicine, success relies on precise processes, as well as the direct interaction with the patient. And as experts in personalized medicine, we know that each patient is unique, even in a public health crisis. Personalized medicine, such as advanced genomic analysis of tumors or individualized CAR-T cell therapies, is built around that premise. Personalization brings complexity, and success depends on efficient supply chains and accurate workflows as much as the right test or treatment. If this precision is possible in personalized medicine, we can certainly deliver it for coronavirus testing.
As coronavirus testing stands now, most doctors and patients rely on a “sample and ship” process to centralized labs—that is if they have access to sufficient testing at all. While rapid point-of-care testing is emerging, it isn’t yet widely available. Instead, patient samples must be collected at points of care, including drive-thru testing centers, and shipped to centralized labs. Results often take 48 to 96 hours, in the best of scenarios—if a longer cycle of error-ridden “#covid19purgatory” doesn’t arise. Demand continues to outstrip supply as testing becomes a linchpin of reopening the economy.
The rules must change if we are going to stop testing chaos. We must focus on the data management, supply chain, and logistics underlying the current “sample and ship” testing process. As former FDA Commissioner Dr. David Kessler stressed, coronavirus testing requires greatly improved sample logistics and “a data management system to handle the flow of specimens and the resulting information, including the delivery of results.”
We couldn’t agree more—because in personalized medicine this is managed every day. Precise digital processes have enabled personalized tests and treatments for hundreds of thousands of patients with cancer and rare disorders. A leading provider of CAR-T cell therapies had already figured out how to keep their supply chains moving amid this pandemic.
Personalized medicine thinks about data management across three “chains.” The first is “Chain of Identity,” or the permanent linkage of a patient’s unique identifiers to their sample throughout the end-to-end medical process. Next is “Chain of Custody,” or the permanent data capture of the people, locations, and times involved in handling the sample. And third is “Chain of Condition,” related to the quality of the sample, such as sample temperature during transport.
Those three “chains” are essential for accuracy, quality, and reliability. That said, they require a lot of data, and produce even more data in turn.
Even with these data volumes and complex logistics, personalized medicine providers have developed solutions that work. In our experience, there are three focus areas that will dramatically improve coronavirus testing.
The biggest area of potential is digital automation. Yes, this is a constant mantra in healthcare. But manual processes cost us time and lives right now. We applaud drive-through coronavirus testing, but wince at photos of testing teams with clipboards. Automation reduces errors, speeds analysis, reduces costs, and improves accuracy. Manual processes may look simpler at first, but often break at higher volumes.
Next, we need standards that provide consistency. The quality and accessibility of testing data will vary widely across the healthcare system. Establishing clear standards for data formats, data capture, and results is essential for speed and reduction of medical errors. The FDA previously announced pilot projects to create standardized databases for T-cell based therapies. If data standardization can be envisioned for these complex therapeutics, we can figure it out for coronavirus testing.
Finally, patients and doctors must be able to trace the process. As noted by the patient trapped in testing purgatory, “for the vast majority of potential Covid-19 patients in the U.S., there is no one point of contact, no tracking number, no monitoring system.” For speed and accuracy, the process must be clear, so that care is enabled and the incidence and spread of disease are accurately tracked. Digital solutions provide genuine traceability, faster answers, and aggregated data analysis that delivers broad actionable insights.
And the need doesn’t end with diagnostic testing. Improving the process now will greatly improve the prospects for effective serology/antibody testing in the near future—another critical step in returning societies to some semblance of normal life.
We know it is possible to provide this infrastructure. While rapid point-of-care testing scales, centralized testing must take pages from the personalized medicine playbook. We must modernize testing’s data management and logistics to ensure reliable, scalable coronavirus diagnostics, now. Stopping this pandemic requires it.
Mike Pellini, M.D., is a Managing Partner of venture capital fund Section 32 and the former CEO and Chairman of cancer genomics testing pioneer Foundation Medicine.
Vance Vanier, M.D., is an emergency medicine physician, a clinical assistant professor at Stanford University Medical Center, a founding partner of healthcare investment firm Chicago Pacific Partners, and the former CEO of genomics innovator Navigenics.
Amy DuRoss is the CEO and Co-founder of Vineti, a digital technology provider for personalized therapeutics, and co-founder and executive director of Proposition 71, California’s $3 billion stem cell research initiative passed by voters in 2004. The authors can be reached at amyduross633@gmail.com.
