For 20 years, Happy Valley-founded company Salimetrics LLC and SalivaBio LLC have championed saliva as a non-invasive, easy to collect sample for diagnostic and research communities. So when COVID-19 started to sweep the world, they immediately asked, “How can we help?”
Early on in the pandemic, Salimetrics started to work with researchers and companies to increase capacity for low-cost saliva-based testing alternatives – something they’ve been doing within the immunodiagnostic industry for over two decades.
"Our team has studied saliva – our experts know how to collect it, how to handle it, how to process it, how to test it, and working closely with the scientific community, we are connected to the leaders in the field who know how to interpret the results," says Hans Schroeder, CEO.
When done right, saliva is safe, fast and easy to self-collect for most people. Other COVID-19 testing methods, like nasopharyngeal swabs, have been severely limited by the supply chain and are significantly more complicated and uncomfortable to collect. In contrast, SalivaBio's Saliva Collection Aid (SCA) makes saliva easy to collect; works with many different brands of standard laboratory tubes; and can quickly be scaled to support the substantial increase in needed testing capacity, making saliva a viable choice in the fight against COVID-19.
Salimetrics' COVID-19 contributions include providing collection devices for molecular testing; developing a new collection device that optimizes sample collection specific for infectious disease antibody testing; working with researchers on a high-sensitivity, high-specificity COVID-19 saliva antibody test; developing its own COVID-19 saliva antibody test for serology research use only; and operating its SalivaLab with BSL-2 safety in support of the salivary bioscience research community.
"We needed to be ready," says Douglas Granger, Ph.D., founder of Salimetrics and co-editor of the recently published book by Springer, Salivary Bioscience: Foundations of Interdisciplinary Saliva Research and Applications. "So our team made the investment in infrastructure ahead of time to ensure we could be counted on when the time came."
Salimetrics will have the capability to supply 2 million SCAs per month as early as September and 4 million per month as early as October, with the potential of more than 20 million per month by the end of the year. The increased capacity will come with additional investment.
The FDA recently issued an EUA to Yale for its SalivaDirect test for rapid detection of SARS-CoV-2, making rapidly expanded COVID-19 saliva testing now possible. Concurrent announcements by the University of Illinois and the NIH RADx initiative show saliva as an important tool in the fight against COVID-19.
Saliva is easy to collect in most people, but since it is a complex oral fluid, the collection, handling and storage prior to analysis is sometimes misunderstood. Drawing from its decades of experience in salivary bioscience research, Salimetrics has created a Saliva Collection Handbook, Saliva Collection Training and collection videos to enable proper saliva collection methodology.
"Not only is it important to match the type of oral fluid required to the test, but designing a protocol that maintains sample integrity from mouth-to-bench can be critical to a successful application," says Supriya Gaitonde, Ph.D., Salimetrics Senior Applications Scientist.
SalivaBio also offers custom engineered solutions, recently developing a new collection device that optimizes sample collection specifically for infectious disease antibody testing. This device, the Saliva Collection Aid-OMT, collects an enriched fluid sample by specifically targeting collection at the gumline, where antibody concentrations are the highest, thereby increasing the suitability of saliva.
"The SCA-OMT has demonstrated its ability to collect samples with substantially higher concentrations of Total IgG, reducing the likelihood of inconclusive results," says Steven Granger, Ph.D., Chief Scientific Officer at Salimetrics. "This is critical for the ramp-up in COVID-19 antibody testing, which is soon to come. We've leveraged our knowledge in the development of simple, elegant design solutions for collection devices.”
When Salimetrics began in a “dark, underequipped basement lab” at Penn State in the 1990s, salivary cortisol was attracting considerable empirical attention. Doug Granger and his team noticed that assays used in research weren’t standardized, so comparing data between studies was a challenge.
“At that time, the immunodiagnostic industry was unwilling to develop and commercialize assays designed specifically for saliva," says Granger. "Our team recognized the importance of better assays to this emerging scientific endeavor. That led our group to take a leap of faith that would result in the much needed 'step up' in assay quality, precision, accuracy and standardization for salivary cortisol. So, we maxed out our credit cards and charged ahead."
With help from Ben Franklin Technology Partners and Dan Leri at Innovation Park, the company launched. For the next 20 years, the company witnessed exponential growth in knowledge facilitated by salivary bioscience research. Advancements have included salivary measures of environmental chemical exposure, infectious disease, metabolomics, oral microbiome and inflammation.
Today, more than 20,000 researchers use the company's products, measuring environmental chemical exposure, infectious disease, metabolomics, oral microbiome and inflammation. The assays have been used in more saliva-related published papers than any other assay in the field.
In 2013, Salimetrics relocated its technology center and saliva testing laboratory to Carlsbad, California. The office staff, manufacturing and fulfillment portions of the company remain in Innovation Park, right where they began. And just as they’ve always done, they are meeting current needs with affordable, reliable, non-invasive saliva-based testing.
“If you want to collect the right sample, at the right time, while maximizing participant compliance, we can help,” says Steven Granger.
To learn more about the SalivaBio collection devices offered exclusively through Salimetrics, researchers can visit Salimetrics.com.