At the onset of the COVID-19 pandemic, Yale School of Medicine’s Molecular Diagnostics Lab did what clinicians and scientists around the country and throughout Yale did. It pivoted. A part of the Department of Pathology, this clinical lab is typically responsible for tissue-based molecular testing related to a cancer diagnosis, the well-known realm of a pathology sub-specialty practice. The pandemic calls for all hands on deck to increase Yale New Haven Health System’s testing capacity. Under the guidance of Pei Hui, MD, PhD, clinical director of Pathology’s Molecular Diagnostics Lab, the team, in collaboration with the Department of Laboratory Medicine, prepared the CLIA certified, CAP accredited clinical lab to develop and validate COVID-19 tests, specifically high complexity tests with PCR (polymerase chain reaction) methodology. Within two weeks, by April 1, Yale Pathology’s Molecular Diagnostics Lab notified the Food and Drug Administration (FDA) that it was ready to go.
Meanwhile, at Yale School of Public Health (YSPH), researchers led by Nathan Grubaugh, PhD, assistant professor of epidemiology (microbial diseases) and Anne Wyllie, PhD, associate research scientist in epidemiology (microbial diseases), were developing an alternative to the often-uncomfortable nasopharyngeal swab tests that had become the early testing standard during the pandemic. By early June, YSPH’s saliva-based COVID-19 test was ready for clinical use, but the researchers needed a lab for clinical validation.
“We helped them make the final push to make the SalivaDirect test a clinical reality,” says Hui. “These types of collaborations, between researchers and clinical laboratories, are how science moves into the clinic. This is the perfect example of what these types of collaborations can do in a pandemic.”
The Molecular Diagnostics Lab performed the clinical validation necessary to get the SalivaDirect testing method ready for emergency use authorization by the FDA, which it received on August 15. As soon as the testing method was approved, the Molecular Diagnostics Lab along with the Yale Pathology Labs (YPL) outreach team, led by Angelique W. Levi, MD, associate professor of pathology, began to offer SalivaDirect to the public.
“We are a university-based lab, not a commercial lab, but we saw an opportunity to partner with Public Health to make an impact during this pandemic,” Levi says.
The test, and this small university lab, do stand to make a big impact. Saliva-based testing offers several advantages over the nasopharyngeal swabs the world came to know during the pandemic. First, collecting a saliva sample is more tolerable. The ease of self-collection is important particularly in the setting of surveillance testing for the general public, as well as for patients and health care workers. Second, the SalivaDirect technology does not use RNA extraction, which takes more time and requires materials that were vulnerable to supply shortages earlier in the pandemic.
“It basically cuts that bottleneck out of testing,” says Chen Liu, MD, PhD, chair and Anthony N. Brady Professor of Pathology. “That shortens the process, speeds the turnaround time, and cuts the cost. And it circumvents the supply chain interruptions happening during this pandemic.”
The testing technology itself is open source, which Hui describes as a “patriotic act.” “It’s a Yale brand, but any existing diagnostic lab in the U.S. that has the PCR setup can easily adopt it,” Hui says. “We are not seeking to have a proprietary platform. It’s completely open to the public, which is remarkable.”
“From a public health standpoint, our collective goal is to increase testing capacity and access on a large scale,” according to Levi. “SalivaDirect is an important step on all fronts toward reaching that goal.”