The COVID-19 pandemic shined a bright light on many challenges facing healthcare systems, but it has also demonstrated the importance of laboratory medicine in managing infectious diseases. By strengthening our clinical lab systems, we now have a unique opportunity to not only mitigate the impact of future pandemics, but also manage the growing burden of chronic diseases that are causing healthcare costs to spiral out of control everywhere.

This is the key message of a new whitepaper by the Project Santa Fe Foundation (PSFF), a non-profit community of clinical lab leaders who have launched the Clinical Lab 2.0 movement to forge the future of laboratory medicine. Central to their vision is the belief that clinical labs can deliver more for healthcare systems by applying their unique data and expertise to manage population health.

Founded in 2016, the Clinical Lab 2.0 movement has done much to help clinical labs go beyond the standard ‘transactional’ model of merely processing samples and returning results for individual patients, an approach that is sometimes referred to as Lab 1.0. From their initial launchpad in the United States, they have worked globally to educate and inspire clinical labs about opportunities to deliver proactive, actionable clinical insight with the goal of improving health outcomes and reducing overall costs.

Theoretically, the COVID-19 pandemic should have been a perfect test case for the Clinical Lab 2.0 model, and in some countries, aggregated lab data on COVID-19 was successfully used for disease surveillance and healthcare systems management. In the United States, however, the pandemic placed such heavy demands on lab systems that many Clinical Lab 2.0 efforts were derailed by the needs of the here and now: running billions of molecular, antigen and serology tests for this single virus.

“When the pandemic arrived in the United States, reality forced us to focus on Lab 1.0,” says Khosrow Shotorbani, President & Executive Director of PSFF and CEO of Lab 2.0 Strategic Services, a consultancy. “But Lab 2.0 is a really important part of pandemic management, and in the long run, the pandemic may ultimately accelerate adoption of the Lab 2.0 model.”

That’s why the new Clinical Lab 2.0 white paper cites the pandemic as a key motivator for elevating the role of the clinical lab in population health management. They see tremendous opportunity to make a difference in infectious disease, putting labs at the centre of public safety and population health efforts.

COVID-19 demonstrated the urgent need for a Clinical Lab 2.0 approach — and it has also given clinical lab leaders the opportunity to make their case. “One of the goals of the Clinical Lab 2.0 initiative is to make sure labs have a seat in the C-suite,” says Mark Fung, Vice Chair for Research (Pathology & Laboratory Medicine) at the University of Vermont Health Network. “Certainly when it came to COVID-19, the value of the lab became very clear.”

That development has set the stage for greater adoption of the Clinical Lab 2.0 concept. “The relationships between the lab and the health network leadership are now in place, and there’s greater credibility,” Fung says. He believes the next window of opportunity to show what Lab 2.0 can do is for labs to help address the significant delays in chronic disease screening and management that happened as a result of the pandemic.

As noted in the white paper, labs operating with Lab 2.0 principles could promote the early identification of risk for chronic disease among their patient populations and highlight opportunities to intervene early. One example they cite is the potential for lab data to identify acute kidney injury by detecting clinically significant changes in creatinine levels—even when the patient remains within a normal creatinine clearance range.

Labs can also find ways to become more involved in point-of-care testing and home testing, two areas that could pave the way for greater impact in the communities they serve. That will be particularly important in dealing with the healthcare challenges of an ageing population.

“Our disease prevalence is going to be increasing over time,” says Fung. “One of the goals in population health is to identify people earlier in the pipeline where we can use cheaper interventions to keep them healthier longer.”

The white paper notes that clinical lab teams can take several actions to move toward a Clinical Lab 2.0 model. This includes implementing technologies that enable the generation of actionable data in real time; engaging organisation leadership to identify new opportunities for the lab to make a difference; investing in data analytics; and working with clinical care partners to support early interventions to slow disease progression.

To learn more about these opportunities, check out the full whitepaper on the Clinical Lab 2.0 website.