In one of the first private-public partnerships of its kind, Linden Capital operating partner Joe Bernardo is helping steer a recently launched national testing registry to tackle many questions around covid-19 supply and demand imbalances.
At its core, the AdvaMed (the Advanced Medical Technology Association) registry was built as a means to streamline communication and data sharing on testing between diagnostic companies and the multiple levels of government – ultimately fueling greater coordination in covid-19 responses.
“When you look at the data of [700,000 plus] tests a day and why is it not enough, you need to ask a second order question of who’s getting it, why is it getting it, and the registry helps get to those answers,” Bernardo, vice chair of the AdvaMed Recovery and Rebuilding Task Force, told PE Hub.
The registry, launched July 21, was formed by AdvaMed in partnership with 13 diagnostic manufacturers: Abbott, BD, bioMérieux, Bio-Rad, Beckman Coulter, Cepheid, Hologic, Ortho Clinical Diagnostics, QIAGEN, Roche, Sekisui, Siemens and Thermo Fisher Scientific.
By pooling together information from the diagnostic companies with publicly available data, the registry has developed one centralized place that tracks the state of covid-19 tests in the US. It offers weekly state- and national-level updates on the number of molecular, antigen, and serology (antibody) tests shipped.
While the US says it is performing more than 700,000 tests a day, the registry’s data has found that manufacturers are producing more than 1.2 million tests per day that are going out into the field, said Bernardo, a veteran executive with past leadership positions at companies including Thermo Fisher, Siemens, Abbott and former Linden portfolio company SeraCare.
Further, there’s a big lag in testing turnaround times in many instances.
AdvaMed’s supply side registry, in combination with other potential future partners, will enable both the public and private ecosystems to “untangle that dilemma and ensure our symptomatic ill, our essential workers and our tracking/tracing programs operate at the greatest efficiency as we move into the fall season,” according to Bernardo.
The real shortages
Once there’s an understanding of where the shortages lie, the public-private partnership can begin to tackle these bottlenecks, so long as there is cooperation from the other parts of the ecosystem, Bernardo said.
For example, on the molecular testing front, the actual amplification (testing) reagents that run a test are not the cause of the shortage. Rather, the majority of the time, the bottleneck lies in the short supply of swabs and other items such as viral transport media (which preserves a patient’s test sample) so that it is stable while transported to the laboratory, Bernardo said.
Other bottlenecks could include extraction reagents and the physical pipette tips used to automate sample handling for lab developed tests (LDTs).
This varies by lab and geography; thus a comprehensive supply-and-demand-side registry would be very helpful, he said.
“You need to actually dissect this generic word: reagents – and define those specific products that are in short supply in a given specific lab or region.”
Another issue the registry is looking to address is the lack of homogeneity in the healthcare system.
“We have a decentralized healthcare system,” Bernardo said. “Decentralized is not a bad word. What I mean is we don’t have a universal healthcare system like some countries in Europe, where there is one common medical electronic record; one common laboratory information system; one common payer, and one common approach to testing.”
That ultimately means laboratories and hospitals have a hard time interfacing with each other electronically and physically.
So, if you send your specimen to a lab that doesn’t have the same assay as your local lab, [doesn’t] have medical coverage or you mislabel that specimen in any way, those results will either not get run at all, or not get back to the right person, Bernardo said.
Two more components across the supply chain ecosystem are ultimately needed, Bernardo said, as the registry’s existing diagnostic partners only give you around 60 to 70 percent of the full picture.
That includes folding in data from centralized reference labs including LabCorp, Quest, Sonic and BioReference, all of which receive and run tests on behalf of other testing locations, oftentimes coming from other states.
These labs could simply drop data into AdvaMed’s registry, as could the plastics and transport companies that work with diagnostics manufacturers, Bernardo said.
“We want to make sure that the tank, the dredge and the oil are all in the same place,” Bernardo said.
Action Item: Read more about AdvaMed’s national registry.