A diagnostics technology company that created a breakthrough blood test to warn doctors of imminent kidney transplant rejection announced Wednesday it is suing a competitor trying to do the same thing.
CareDx, Inc., patented a minimally invasive blood test, AlloSure, that detects kidney rejection at least two weeks after a kidney transplant, which can warn doctors if organ rejection is looming. A rival diagnostics company, Natera, Inc., created their own blood test called Prospera and backed their development with what CareDx lawyers call a “deeply flawed” and “unreliable” study meant to fool physicians and patients.
In the complaint filed in the U.S. District Court in Delaware, the CareDx legal team said Natera lied to the Federal Trade Commission about the study’s sample size, which was smaller than reported, and pooled biopsy data to report what Natera wanted to show.
CareDx said that “Natera’s deceptive claims also disparage AlloSure.”
Natera’s 2017 study says the company’s test adheres to the standard criteria for kidney transplant rejection diagnostics called the Banff rules, which determine whether a diagnostic test will be accepted into the scientific community. That was a lie, the lawsuit claims.
The CareDx legal team says Natera “has begun a false advertising campaign designed to deceive doctors … and patients”. The complaint says Natera also violates the Lanham Act, an anti-trademark infringement measure dating back to 1946 when President Harry S. Truman signed it into law.
According to CareDx data, AlloSure is currently used in more than 100 healthcare centers and helped the company’s revenue soar in 2018 with an 88% jump.
Natera released a statement in March about the suit filed against them, saying they “are confident that [they] will prevail” and, “In recently published studies, Natera demonstrated superior analytical and clinical test performance.”
