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New Laboratory in Lake Mary

Pathnostics Lake MaryPathnostics, a precision diagnostic testing and development company, announced the broadening of its diagnostic laboratory capabilities with the opening of its third lab, located in Lake Mary, Florida, and expansion of its Irvine, California-based laboratory and headquarters.

These strategic investments are designed to support increasing demand and planned new test launches, with additional laboratory expansions expected in the future to keep pace as the company’s business continues to grow. The initial 8,500 square foot facility will add approximately 30 local jobs to start, with additional employment opportunities expected in 2023 as well as opportunity to expand Pathnostics’ laboratory footprint.




The Lake Mary laboratory will initially be focused on Guidance UTI, Pathnostics’ advanced diagnostic testing for the rapid identification and precise treatment of complicated, recurrent and persistent UTIs – and the only UTI diagnostic to combine PCR and Pooled Antibiotic Susceptibility Testing (P-AST™), which better address polymicrobial infections where bacterial interactions can impact antibiotic resistance.

“Florida is a strategic addition to our laboratory network as we scale our Guidance UTI business” said David Pauluzzi, CEO and Vice Chairman of Pathnostics. “With compelling real-world evidence demonstrating significant health outcomes and cost-related benefits compared to standard urine culture, Guidance UTI offers patients, providers, and payers a one-of-a-kind solution to this complex health challenge that can help get patients on the right treatment plan sooner. The new facility in Florida will serve and improve turnaround time for clinicians and patients and ensure business continuity as we relocate our Irvine, CA headquarters to a newly built, larger facility in Irvine as demand continues to grow nationwide.”

In addition to the new facility in Florida, Pathnostics is expanding its laboratory and headquarters in Irvine, CA from approximately 35,000 to approximately 55,000 square feet, with full relocation expected by the end of 2022. This move consolidates Pathnostics’ Irvine presence, leading to increased capacity to perform testing and space to scale its biorepository and informatics infrastructure, which will result in operational efficiencies. This expansion further supports additional clinical studies planned and in progress that add to Pathnostics’ growing body of clinical evidence, for its existing and forthcoming advanced diagnostic testing, and provides room for planned new product line expansion. The new facility provides better working space for employees as the company continues to invest in talent to better support customers. Among a variety of career advancements available, in 2023, Pathnostics will support an HT/HTL training program to further education and certification of technical staff in histotechnology, a role critical is serving clients and patients in the field of cancer diagnostics.

“We are thrilled to expand our headquarters as we continue investing in our infrastructure,” said Pauluzzi. “This move enables us to better serve patients and providers with more convenient access to our currently available, advanced diagnostic solutions. It also supports our expansion in cancer diagnostics, women’s health, and the addition of a new disease area to our Guidance franchise – all coming in 2023.”

In addition to the facilities in Florida and California, Pathnostics currently has a CAP (College of American Pathologists) accredited and CLIA (Clinical Laboratory Improvement Amendments) certified laboratory in Royal Oaks, Michigan.

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