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The test, the agency said, is the first authorized by it for use with flow cytometry to detect leukemias and lymphomas.
The deal covers Streck's cell stabilization and molecular products, including the soon-to-be released Zulu RT, a rapid real-time PCR instrument.
The ASPIRE algorithm uses cell phenotype information from bone marrow samples to predict which patients will relapse and which will go into remission.
At the American Association for Clinical Chemistry meeting, Theranos CEO Elizabeth Holmes said her company is working on third-party review and publications of the firm's technologies and tests.