Valerie Neff Newitt
May 2025—Despite its extensive portfolio and multiple manufacturing sites, simplicity seems to be at the heart of StatLab, thanks to its self-manufacturing approach.
Four years ago, StatLab was primarily a distributor of medical products and manufacturer of a select few. Acquisitions, investment, and a change in the company’s profile came with new ownership, and the company, based in McKinney, Tex., is now “a full-fledged manufacturer across the entire histology portfolio,” says Joe Bernardo, chairman of the board of StatLab.
“I think we’re the only company that can say we self-manufacture all the components of preanalytical consumables and equipment, from prefilled formalin to H&E staining—even processors,” Bernardo says. “And because of that we can provide three things every lab looks at.”
Price is No. 1, “and because we control the manufacturing in country or in continent, we can get to a price point that is extremely beneficial for our customers,” he says.
Quality, No. 2, came with the capital investment to build and optimize all factories in the past four years. “We control the process from raw materials to end users, and because we can control the quality of our glass, our chemicals, our plastics, we can ensure that when laboratories get to the analytical phase, they have the best specimen integrity possible. This is becoming more critical,” he says, “with the advent of digital pathology.”
The third is innovation. “Because we have the extraordinary founders of the businesses we acquired, we brought together researchers, all from the bench, who have 10 to 30 years of experience.” Now they’re working together to ensure seamless compatibility between equipment and consumables.
The result: “We make life easier for histologists.”
StatLab’s portfolio is a broad one. It consists of prefilled specimen containers, reagents, cassettes, stains, control slides, marking dyes, paraffin, slides and cover glass, printed diagnostic slides, and a variety of ancillary reagents. Its equipment consists of cassette and slide printers, processors, microtomes, embedding centers, and stainers, and small equipment like slide dryers and paraffin trimmers. “We manufacture everything but blades,” Bernardo says.
On a scale of one (commodity) to 10 (“massively differentiated,” he says), “the entirety of the portfolio gives the lab the innovation, price, and quality that gets us to an eight or nine in terms of an overall solution for a given lab because we’re hitting all the things they need plus price,” Bernardo says, adding, “It’s an unusual position to be in.”
What explains his reasons for what he sees as differentiated products from StatLab? He uses the prefilled formalin containers (StatClick Prefills) as an example. “The lids make an audible click when the seal is properly engaged, preventing users from over- or under-tightening the lid and dramatically decreasing the risk of leakage during transfer,” he explains, noting StatLab has its own molds, manufacturing, and quality release program.
For its chemicals, instead of purchasing containers, StatLab now blow molds its own bottles, Bernardo says, and in so doing created a patented reagent bottle that reduces glugging and splashing and has handles on the top and back. It’s an F-style bottle. “So instead of getting round bottles, only six of which fit in your fireproof storage, you can fit nine F-style rectangular bottles in the cabinet.” They’re easier to store, he says, and easier to use when handling hazardous chemicals.
StatLab’s KT slides are made in the company’s plant in Germany and were developed with digital pathology and IHC staining in mind, Bernardo says. “We know from research and experience the requirements for slide scanners, and worked to launch a range of slides that scan flawlessly.”
With tariff-related turbulence in the news in mid-March, Bernardo said at the time that he sees StatLab as “well insulated” from potential supply chain problems owing to its heavy U.S. and European Union manufacturing focus. “There are a few things we acquire—for example, hematoxylin powder from logwood trees that are primarily in Latin America. That was an issue for suppliers during the last supply chain shortage,” he says, “but it was not for us. We have a dedicated sourcing team that ensures our raw material supply is readily available for a ramp-up for our customers.”
StatLab’s manufacturing sites are in McKinney and Arlington, Tex.; Newtown, Wales; Polegate, England; Braunschweig, Germany (for glass manufacturing, to be “copycatted” in Arlington, Bernardo says); Monrovia, Calif.; and Chicago, where it manufactures its microbiology diagnostic consumables, Gram stain control slides, and tuberculosis testing products. Instrument manufacturing is for now in Europe. “We will introduce their processors and microtomes and other products to the U.S. in the next few years,” Bernardo says of two sites, one near Barcelona and another in Martinengo, Italy.
StatLab was purchased in January 2021, and Bernardo describes the companies purchased since then as “founders, entrepreneurs, and researchers” who left corporate environments that didn’t suit them “to create more innovative products, but needed more infrastructure and resources to scale.
“I knew where they existed because I’ve been in the industry for 30 years,” he continues, “and we went to each of them and rolled them up and now they’re ecstatic to be together.”
“The world was commercially ripe for us to make acquisitions and investments,” he adds, to provide a solution for laboratories.
Bernardo spent more than 25 years with Thermo Fisher Scientific, Siemens Healthcare, and Abbott Laboratories. He became president in 2015 of Thermo’s next-generation sequencing and oncology division. He is a strategic business advisor at Rarity Bioscience.
He reports that StatLab entered into contracts recently with Medline, Cardinal Health, VWR, and Fisher Healthcare. After having invested extensively in its manufacturing facilities, he says, “we really got going in the past 18 months, and now we’re activating the benefits. People are coming our way; distributors are choosing us. We have a long way to go”—he says the company is growing at double digits annually “with aspirations to keep growing. I think we’re going to be the preeminent supplier five years from now.”
Valerie Neff Newitt is a writer in Audubon, Pa.