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The San Francisco-based startup believes that its QiSant assay could help guide the use of immunosuppressive drugs and other therapies to prevent kidney transplant rejection.
The RT-qPCR test was made available last week after validation in accordance with the US Food and Drug Administration's Emergency Use Authorization guidance.
CareDx first sued Natera in April 2019, accusing the company of trying to mislead patients and clinicians about the superiority of its Prospera transplant test.
CE marking of PromarkerD Hub complements the CE mark that the mass spectrometry version of the test received in November.
The magistrate did recommend that the court dismiss two counts made against Natera with respect to trademark disparagement and unfair trade practices.
Effective Feb. 3, 2020, the donor-derived cell-free DNA test will be covered for all kidney transplant recipients, including those with multiple kidney transplants.
A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.
Opko logged $181.1 million in revenues from services, $26.2 million in revenue from products, and $21.5 million from licensing and intellectual property.
The company reported $33.8 million in total revenues for the quarter and said testing services revenues rose 68 percent year over year.
The researchers said the test performed well in distinguishing patients with or without complications and proved itself better than frequently used clinical variables.