NEW YORK – A new enterprise seeks to connect employers baffled by the nearly 150 US Food and Drug Administration Emergency Use Authorized molecular diagnostic tests for COVID-19 to labs with extra capacity of high-quality testing.
The team of scientists and medical experts at New York City-based Resilience Health is curating a comparison of EUA molecular tests to provide consulting services, and is also offering this evidence base for the public good.
Resilience Health was co-founded earlier this year by genomics researchers at Weill Cornell Medicine Chris Mason and Matthew MacKay, and Nick Haft, a life sciences ventures investor. The company is registered as a public benefit corporation, meaning it focuses on meeting societal needs as well as creating profits, and as such it freely offers its analyses of EUA diagnostics on its website.
Jonathan Feldstein, the president and chief operating officer at Resilience Health and also a medical doctor, said that the company's overall mission is to improve health security in the workplace. Although this is typically the purview of governments, "We noticed that during the COVID-19 pandemic the onus has fallen upon business owners and operators to take action to safeguard their employees, customers, and by extension, their communities," Feldstein said.
But very few commercial enterprises have in-house public health, epidemiology, and infectious disease diagnostics expertise. "Given the current economic pressures, they are just trying to keep their businesses afloat," he said.
The firm's health security operating system is validated by a multi-disciplinary group of scientists and researchers, Feldstein said, which enables businesses to "make the right decisions to keep their employees healthy, safe, and secure."
The decision to form as a PBC instead of an entirely for-profit corporation is "a reflection of the founding team, and the priorities of the team to help the greater community and to extend a knowledge base that at times can be siloed within academia or biopharma," he said.
The company essentially normalizes and standardizes diagnostic test information from EUA submissions and instructions for use documents. The initial dataset was published earlier this month in Nature Biotechnology.
Resilience Health also offers services like proprietary risk modeling and digital tools around compliance and operational guidance, and these tools are "backed by a suite of consulting services that help business leaders make data-driven and evidence-based decisions," Feldstein said.
Specifically, the firm is working with large national retail companies like Warby Parker and biotech companies like Finch Therapeutics. It is also extending its services to non-profits and smaller family owned businesses. Feldstein said this includes employers such as an apple orchard in upstate New York and a small medical and electronics manufacturer.
Feldstein said that, "There are good tests out there, but there are so many tests that were made available through the EUA process that sometimes it is difficult for a non-technical person to distinguish if the test available to them at their local or regional lab is of the same caliber as a test offered by a reputable national lab, like Quest or LabCorp."
The national labs also have commitments to more acute care settings, and the turnaround times are in practice between five and seven days for non-urgent cases.
On the other hand, "There are numerous smaller regional labs that have capacity that is just going unused," Feldstein said. "Businesses just haven't connected with these labs because they aren't aware of this capacity, and they are rightfully skeptical of their quality given the flood of EUA tests."
Resilience identifies labs that it deems to be reliable and high-quality based off of a number of parameters, including test type and turnaround time. "We can connect small businesses that want to test [and] take every step that they can to protect their employees with these labs," Feldstein said.
The costs of the services vary with the type of company and how comprehensive of guidance the customer needs, he said.
Mason noted that while it all began with the thought, "I wish there was one place where we could look at the limits of detection and current parameters of different tests," now, the dataset on the website makes it "easy for people to look things up." For example, test makers can quickly see where the performance of an assay in development fits in a broader context, he said.
Although many early comparisons of molecular assays for SARS-CoV-2 had seemingly suggested that they perform substantially the same in clinical samples, particularly from symptomatic people with presumably high viral loads, the Resilience Health team has found that EUA molecular diagnostics can differ in terms of LoD by a range of more than five orders of magnitude. At the low end are tests from Perkin Elmer, Quest Diagnostics, and Roche, while at the high end are tests from Northwestern University and Warrior Diagnostics.
These LoD differences are potentially consequential, since the Nature Biotech study points out that each 10-fold increase in the LoD of a COVID-19 viral diagnostic test is expected to increase the false negative rate by 13 percent according to one evaluation posted to bioRxiv.
Mason said the team has also gleaned a number of issues in the process of standardizing the information. "For example, two different EUAs don't even tell you what part of the genome they are targeting," he said. And, for the LoDs, "Some report copies per milliliter and some copies per microliter, so that is easy to convert, but others sometimes report infectious copies," he said.
Resilience Health considers itself to be unique in its analytical approach, and in the fact that it is founded by diagnostic scientists and physicians. Similar evaluations are being done by groups like the Foundation for Innovative New Diagnostics and the COVID-19 Testing Project, and research teams are also running head-to-head comparisons. But many of the efforts so far are either focused on antibody and antigen testing, or are selecting RT-qPCR lab tests piecemeal to compare rather than looking at a global view of all EUA tests.
Now, "We know that some tests are better, and some are maybe not ideal for different applications," Feldstein said, for example a test with a high limit of detection would not be a first choice for pooling-based employee screening.
Resilience Health has partnered with a testing logistics provider, CoVerify Health, to help identify labs to liaise with, Feldstein said, and the team works with the labs to "get a better understanding of how their test is performing, based on their most up to date data."
The specific test and metrics of the lab's quality and skills are crunched, and, "If we are confident in the lab's test to perform, then we help small- and medium-sized businesses connect with these labs to align capacity for themselves," Feldstein said.
MacKay, who serves as a scientific advisor at Resilience Health, noted that he and Mason had worked on EUA submissions with other groups in recent months, "so we have a fairly good understanding of how the whole process works and what the rules are in order to read the [FDA] documents and understand what they are actually saying."
The company also has a team of diagnostics scientists, including principal investigators, postdocs, and masters and PhD students who comb through FDA documents and work on aggregating and standardizing the data and putting it into the database.
Feldstein said that companies are welcome to contribute updated information about their tests.
"Our intent is to make available the most recent and accurate data," he said. "The initial data pool was from the EUA filings, but if there is more up to date data we would be more than happy to implement it and we accept submissions from any company that has more accurate data," he said.
The Nature Biotech study also incorporates a description of the Rapid COVID Screening XPrize for which Mason and MacKay serve as scientific advisors. The understanding of the current EUA landscape is now helping them evaluate the hundreds of projects have been submitted, Mason said.
Overall, Feldstein said Resilience Health is trying to expand access to testing as much as possible. "We're happy to welcome conversations with test manufacturers and labs that have capacity, because there is no shortage of small- and medium-sized businesses that would love to access that capacity to safeguard their employees," he said. However, he noted that Resilience Health expects to use EUA and IFU documents from the FDA website as the "ground truth," with any updates incorporated into the database in order "to remain unbiased and always represent the current state of the field."