United Therapeutics backs TAI, pens organ monitoring pact

United Therapeutics' headquarters. (United Therapeutics)(United Therapeutics HQ)

United Therapeutics has helped TAI Diagnostics raise $10 million. TAI will use the cash to advance the cell-free DNA (cfDNA) transplant monitoring technology that attracted United Therapeutics.

Milwaukee-based TAI is developing tests to improve the surveillance of the recipients of organ transplants. These patients take immunosuppressants to reduce the risk of their immune systems rejecting the transplanted organs. But the risk of rejection remains and the immunosuppressant dose needs modifying over time to give the best odds of success.

In the case of cardiac transplant patients—TAI’s first target population—endomyocardial biopsies are taken for surveillance purposes. These tests are invasive. And, in TAI’s view, they are expensive and prone to sampling error.

TAI is working on noninvasive assays it sees as a better option for patients and healthcare systems. The genotyping assays analyze blood samples to quantify the release of donor-specific cfDNA from transplanted organs. In doing so, TAI thinks it can measure organ injury and thereby assess the status of a patient’s transplant.

The idea has secured TAI $21 million in funding, the latest tranche of which was unveiled this week. TAI first disclosed the series A in 2015, at which point the size of the round stood at $8.2 million. With the help of United Therapeutics, TAI has added to that haul for the final close of the round.

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United Therapeutics’ interest in TAI is more than just financial. The company also sees TAI’s tests as potentially complementary to its interest in improving the supply of organs to patients.

“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 cfDNA technology nicely complements our efforts,” United Therapeutics EVP Paul Mahon said in a statement.

United Therapeutics is researching xenotransplantation, organ manufacturing, regenerative medicine and ex-vivo lung preservation to improve access to organs and tissues, and outcomes in recipients. In each case, the biotech could benefit from having a noninvasive way to assess the condition of people who are treated using the technologies.

Teaming up with TAI gives United Therapeutics access to cfDNA monitoring technology that could underpin companion diagnostics for its experimental approaches to organ transplants.