DynaGen Inc. scientists on Monday presented data on two ofthe company's newest diagnostic tests -- for tuberculosis -- atthe World Congress on Tuberculosis in Bethesda, Md.

The tests include a five-minute latex agglutination test fordetecting mycobacteria in sputum, and an enzymeimmunoassay for detecting anti-mycobacterial antibodies. TheCambridge, Mass., company (NASDAQ:DYGN) said that the lattertest can be used to distinguish between patients with activedisease and those who have been either vaccinated or infectedbut are still healthy.

The rapid agglutination test uses latex beads coated withantibodies to mycobacterial surface antigen.

"It is very specific for mycobacteria, and cross-reactivity (withother bacterial species) is virtually non-existent," Indu Muni,DynaGen's president and chief executive officer, told BioWorld.Traditional tests require microscopic analysis of smearedsamples for presence of the bacterium, as well as four to eightweek culturing of those samples. DynaGen's agglutination test is85 percent to 88 percent as sensitive as culturing, and muchbetter than smears, Muni said.

DynaGen's two-hour enzyme immunoassay detects only peoplewith active tuberculosis, Muni said, not those who have had aTB skin test or have been vaccinated. Its advantage over apolymerase chain reaction (PCR)-based test, Muni said, is that"it doesn't require sophisticated instrumentation or expertise tointerpret."

DynaGen has licensed its latex agglutination test toInternational Murex Technologies Corp. of Toronto and itsenzyme immunoassay to Cambridge Biotech Corp. of Worcester,Mass., which "would like to develop it into a five- to 10-minuteformat," Muni told BioWorld.

DynaGen's stock was up 13 cents a share on Monday to $5.25.

-- Jennifer Van Brunt Senior Editor

(c) 1997 American Health Consultants. All rights reserved.

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