Glyko Biomedical Ltd. got FDA approval to market itsfirst diagnostic product, a screening test for children thatcan detect more than 25 lysosomal storage diseases.

The Urinary Carbohydrate Analysis Kit identifiesabnormal carbohydrates in the urine of affected patients.It can be used as a primary newborn screening test for themajority of lysosomal diseases, which include Tay-Sachsand Gaucher's diseases, and affect about five in 10,000newborns, the company said.

Glyko, of Novato, Calif., is developing carbohydrateanalysis systems based on its Fluorophore-AssistedCarbohydrate Electrophoresis, or FACE, technology. TheFACE system includes recombinant enzymes, chemicals,imaging and software.

"The approval allows us to begin marketing to hospitalsand reference laboratories as well as testing on patientsamples here at Glyko," said John Hamilton, thecompany's vice president, finance and chief financialofficer.

Hamilton said the potential market size for screeningnewborns is estimated at $15 million to $20 million. Fourof the company's 18 employees are in sales, currentlyselling Glyko's analytical products line. "They will alsobe calling on the 100 or so reference laboratories in theU.S. that perform these kinds of tests using existingtechnology, such as thin layer chromatography,"Hamilton said.

Glyko is developing three other projects from the FACEtechnology. One is for diagnosing alcoholism, another tomeasure bone metabolism and the third to measureheparin in the blood.

John Glock, president and CEO of Glyko, said the newkit for lysosomal diseases "is a single test that giveshealth care providers a fast, reliable and cost-effectiveway to screen for a whole range of diseases that are oftendifficult to diagnose and costly to treat if detected at a latestage." n

-- Jim Shrine

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