Why this AI diagnostics company is building a St. Pete lab

The founder behind New York-based Renalytix, a publicly-traded company that uses artificial intelligence for clinical diagnostic solutions, has returned to the Sunshine City, where he plans to grow his newest startup. 

Renalytix President Tom McLain, a previous CEO of St. Pete-based biotech company Claro Scientific, has secured a new space to house the company’s research on its chronic kidney and diabetes testing product. 

“We looked at sites near Tampa International Airport, as we need to be close to an airport to receive and send blood samples, but we found the support we had in opening in St. Pete was ten times the support we saw in Hillsborough County,” McLain said. “It was a combo of factors – the St. Pete Area EDC (Economic Development Corp.) and its members had a great interest in helping us. The deal with the landlord was simple and straightforward. For sites in Hillsborough, the deals were very rigid.” 

Thomas McLain, president of Renalytix.  

Site selection consultant Mike Gilson, a former exec at global medtech firm Smith+Nephew, worked with McLain on securing a temporary facility on Pasadena Avenue. In the coming months, Renalytix will move into a permanent site near the OneBlood center in South St. Pete. 

“OneBlood has all the people and talent to support large-scale blood-processing samples. We want to be close to them and the programs that support this type of business,” McLain said. 

Renalytix (NASDAQ: RNLX) uses an AI-enabled algorithm to analyze biomarker values from a patient’s blood sample and health record to determine a patient’s risk for a rapid decline in kidney function. 

The company’s lead product, KidneyIntelX, has been granted a breakthrough designation by the U.S. Food and Drug Administration and is designed to help make significant improvements in kidney disease prognosis and treatment to slow or halt progression early and help patients avoid end-stage kidney disease, dialysis or transplants. The company is working on additional products to measure changes in kidney health over time, identify the most effective therapy for a specific patient and monitor their response to therapy.

McLain explained that Renalytix will build a wet lab space to conduct clinical experiments. The team would also create a research and development hub, training rooms and offices for its back-of-office and corporate operations. 

Prior to scouting sites in the Tampa Bay area, the team considered expanding to North Carolina’s Research Triangle, Tennessee or Indiana. 

“These cities have regional Medicare administrative contractors who make decisions on health care coverage,” he said. 

Medicare administrative contractors are private health care insurers who process claims in assigned territories. Medicare patients make up the majority of Renalytix’s consumer base. 

The company has a lineup of existing Florida-based executives, including a lab supervisor, a lab tech and a vice president of sales, market access and a chief medical officer. With the St. Pete location, McLain said there will be additional positions in customer service and billing. 

McLain said he has connected with the University of South Florida and the CareerSource organization about building a talent pipeline. 

Renalytix has partnerships and contracts with health care systems such as Trinity Health, a not-for-profit Catholic health system operating 92 hospitals in 22 states, and the Orlando VA Medical Center. McLain said he is interested in working with the local VA centers, BayCare Health and AdventHealth. 

“We are close to running our 10,000th blood test and are preparing to submit our first Medicare patient samples from Florida in the next few weeks,” McLain said. “Our product addresses a market with a patient population that’s over 14 million. Kidney disease and type 2 diabetes are the largest chronic diseases. The market opportunity is significantly greater than the addressable market from the previous St. Pete company.” 

Since leaving Claro Scientific in 2013, McLain has served in various C-level positions at companies such as Vermillion, a research group that develops and commercializes diagnostic tests to monitor and manage the treatment of gynecologic cancers, and Exosome Diagnostics, which creates prostate cancer prognostic tests. 

“I’m taking everything I’ve learned to move us forward,” McLain said.