TAI Diagnostics Hires CEO, Nabs $8.3M to Push Post-Transplant Test

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Kentucky or Wisconsin, so they picked San Jose, CA, for Ariosa’s headquarters. In December, Swiss pharmaceutical giant Roche acquired Ariosa. According to Roche’s most recent annual report, the purchase price was $400 million in cash and up to $225 million more in incentives.

This time, the Mitchells are keeping their startup closer to home. This appears to have had little to no effect on their ability to raise capital.

Another step toward commercialization is generating more patient data, says TAI CEO Langley, and the NIH wants to help. In 2013, the government research agency awarded MCW and its collaborators, which include TAI, a five-year, $3.2 million grant to determine whether the encouraging results of a previous 50-patient study could be observed across a larger population.

“The data from the first phase looks very promising,” Langley says. “We’re still recruiting patients for the next phase of the study, which [involves collecting] deeper clinical information.”

TAI is racing its competitors, one of whom has already reached the market. Langley says AlloMap, from Brisbane, CA-based biotech CareDx (NASDAQ: CDNA), is the first blood-based cardiac transplant monitoring product to become widely available. In May, the company announced it had enrolled the first cohort of patients in a study on organ rejection in kidney transplant recipients.

“CareDx is our primary competitor,” Langley says.

TAI could start generating revenue once its reference laboratory receives accreditation and the startup persuades providers its assay is worth ordering. Langley says initially, TAI would handle testing the same way it does today for patients in studies: Samples are shipped from draw sites to the lab for analysis, and TAI sends a report back to the patient’s health system. Several years down the road, Langley says, the company could shift from this centralized, service-based model to a kit-based one. With that approach, TAI would essentially put its technology in a box with instructions, allowing providers to examine samples themselves.

“That’s always a big strategic question for companies like us,” Langley says. “Do we want to be in the service business? Or do we want to be in the manufacturing business?”

Langley has over 30 years’ experience in the life sciences industry. Most recently, he served as vice president and general manager of transplant diagnostics at Immucor, a Norcross, GA-based medical device maker. Before that, he spent more than eight years at Pel-Freez Clinical Systems, which develops molecular and serologic diagnostic products for organ transplantation. While working for Pel-Freez, Langley was based in Brown Deer, WI, meaning his joining TAI marks a return to the Badger State.

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