SYVA's FLUORESCENT IMMUNOASSAY FOR DIGOXIN MONITORING has been cleared by FDA for marketing, the Syntex subsidiary announced Feb. 10. The new test, designed to run on Syva's Advance fluorometric instrument system, "is the only digoxin assay now available that does not require time-consuming centrifugation, precipitation or separation by the lab technician," said Syva. With the Advance system, labs can decrease processing time for the test both on a volume basis, and by reducing the routine procedural steps required of a lab technician from seven (for an enzyme immunoassay), to four, according to the company. Syva already markets several FIA tests in its EMIT line of therapeutic drug monitoring tests. The company believes, however, that the new digoxin assay "could become the cornerstone of Syva's product line," commented Syva President Thomas Gutshall. Syva's newest test "represents a significant application of technology for digoxin assays," which currently comprise "a major portion of the market for therapeutic drug monitoring," Gutshall added. Syva estimates digoxin is prescribed for 11 mil. heart disease patients each year in the U.S. The digoxin assay is based on a naturally occurring fluorescent molecule discovered by researchers at Stanford University, Syva states. Scientists there isolated the molecules from red algae found in San Francisco and Monterey Bays. "Although an enzyme immunoassay for digoxin has previously been available for use on other Syva instruments, the new digoxin assay, available on the Advance, will be a competitive addition to the digoxin assay market," predicts Gutshall. Syva will market the test to hospitals and independent labs via its direct sales force. The cost of the test "will vary," according to the company. Syva currently markets about 30 therapeutic drug monitoring tests, including assays for theophylline, gentamicin, phenobarbital and lidocaine. The company said it has about 32 more assays in development.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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