Leveraging global laboratory scale to deliver critical patient test results on time

Background

Physicians attending to critically ill cancer patients awaited test results from Labcorp's Los Angeles Center of Excellence for Advanced Anatomic Pathology and Histology. These results would determine patients’ eligibility for enrollment in clinical trials that could positively impact the progression of their disease. Unfortunately, the Labcorp laboratory team encountered an unexpected issue with the performance of certain lots of testing reagents. The teams recognized that any delays could prevent patients from being enrolled in potentially lifesaving clinical trials.

Discovering issues with a critical assay

During routine clinical trial testing early in 2024, Labcorp laboratory personnel noticed inconsistent performance of a key immunohistochemistry assay used to determine patient eligibility for a clinical trial assessing a novel investigational therapeutic. To better understand the issue, our laboratory team sought assistance from the assay manufacturer. When the manufacturer confirmed the assay was indeed not performing to release specifications, the Labcorp team immediately suspended testing to avoid exhausting precious patient samples. Given the importance of the test results for patient care, the Labcorp team quickly began to explore strategies to mitigate the issue. A strong collaboration between the Labcorp team and the assay manufacturer was crucial in identifying solutions.

Rallying a network-wide effort 

Leveraging Labcorp’s wholly owned and integrated global network of diagnostic and clinical trial laboratories, our procurement team identified the laboratories within the Labcorp network that performed the specific assay. They were then able to verify the inventory of reagent test kits down to lot numbers before reaching out to request release of any kits they could spare to be shipped overnight to the Los Angeles clinical trial testing laboratory. The Los Angeles laboratory operations team then scheduled additional shifts to perform rigorous quality checks. Technical staff and attending pathologists confirmed the transferred kits did indeed meet the manufacturer’s specifications before resuming testing.

As soon as testing was resumed, the laboratory team worked around the clock to resolve the testing backlog. Labcorp coordinated directly with the clinical trial sponsor so patient test results could be communicated efficiently to investigational sites as they became available. 

The power of collaboration and resilience in patient care

While test performance issues occasionally occur, Labcorp's global infrastructure, industry-leading logistics and dedicated scientific teams work to keep rare disruptions from impacting patients. Labcorp’s patient-centric approach guided cross-functional teams to collaborate effectively and respond with urgency. Despite the challenges, patient test results were delivered well within the laboratory’s standard five-day turnaround time—an accomplishment made possible through strong collaboration among the Labcorp team, reagent kit vendor partner and clinical trial sponsor.

This case study illustrates how leveraging a global laboratory network, a culture of resourcefulness, collaboration and a relentless focus on patient care can help biopharma sponsors and investigator sites navigate challenges and achieve impactful results.

Learn more about Labcorp’s comprehensive clinical trial testing offerings at https://biopharma.labcorp.com/clinical-testing.html