TAI Diagnostics Raises $10M, Inks Deal With United Therapeutics

Xconomy Wisconsin — 

TAI Diagnostics said earlier this week that it had closed a $10 million round of funding and forged a new partnership with United Therapeutics (NASDAQ: UTHR).

Wauwatosa, WI-based TAI, whose name stands for “Transplant and Immunology” and is pronounced “tie,” is seeking to commercialize a non-invasive test to monitor the health of transplant recipients.

Three-year-old TAI said it has now raised more than $21 million from investors, including an $8.3 million funding round that closed in late 2015.

United Therapeutics, based in Silver Spring, MD, provided some of the capital for TAI’s latest financing, the company said. It did not name any of the other participating funds or investors in a press release announcing the round.

TAI’s test measures levels of cell-free DNA, genetic material discharged by the patient’s new organ that can enter the bloodstream. These readings can help doctors and workers at transplant centers assess whether the patient is in danger of rejecting the organ.

“As we continue development toward our goal of creating an unlimited supply of transplantable organs, the importance of transplant monitoring is an area of interest, and TAI’s [cell-free DNA] technology nicely complements our efforts,” Paul Mahon, executive vice president of United Therapeutics, said in the release.

TAI’s announcement did not provide specific financial terms of its agreement with United Therapeutics.

The standard way of testing for organ rejection is by obtaining a tissue sample from the organ—an invasive procedure. For example, testing a heart transplant recipient calls for a tissue biopsy obtained by inserting a wire in the neck, running it through a vein, and collecting the sample from the heart. TAI notes that though these invasive biopsies remain the “current gold standard for monitoring the status of organ rejection,” they bring the risk of infection and can be a lagging indicator of organ damage. A biopsy can also be expensive for the patient and health system, the company said.

TAI aims to improve on the standard methods of testing for organ rejection. All TAI’s test requires is a simple blood draw.

In October, TAI CEO Frank Langley told Xconomy that his company planned to start selling its test in the first half of 2018. Langley did not respond to messages asking whether that’s still the case and when TAI anticipates launching the test. In the news release, the company says the latest funding will support ongoing research and development, clinical studies, and the commercial launch of the test.

Langley said last year that TAI expected to initially sell its test under a centralized, service-based model. Transplant centers—a group that TAI will over time seek to turn into repeat customers—and health systems would ship blood samples to the company’s reference lab for analysis, he said. TAI would then send back a report explaining key findings.

TAI is offering its diagnostic as a lab-developed test, meaning the company can sell it without having received FDA clearance. Under an FDA regulatory exemption, a company that develops and uses tests in-house can do so without needing the agency’s approval.

According to the release, leaders at TAI believe its cell-free DNA technology could have applications in a number of the areas in which United Therapeutics is working, including regenerative medicine, organ manufacturing, and ex-vivo lung preservation.

Another potential use is xenotransplantation, the transplanting of animal organs or tissues into humans. United Therapeutics has been bullish about reviving this once-failed concept, in part through the company’s $100 million investment in La Jolla, CA-based Synthetic Genomics, which is creating pig cells with modified genomes.