The clinical laboratories division of SmithKline Beecham plcplans to offer next month a two-day direct test, based onpolymerase chain reaction (PCR) technology, for the organismthat causes tuberculosis.

The TB testing service, which would compete with traditionaltests that require culturing of samples and four to eight weeksto present results, is the second PCR-based test service to beoffered by SmithKline Beecham Clinical Laboratories Inc.(SKBCL) of King of Prussia, Pa. The company earlier this yearlaunched a PCR-based assay for the direct detection of the HIV-1 virus, which causes AIDS.

SKBCL tests are based on PCR technology licensed fromHoffmann-La Roche Inc. of Nutley, N.J., whose own clinicallaboratory network, Roche Biomedical Laboratories, isdeveloping a PCR-based rapid TB test.

In addition, another Roche unit, Roche Molecular Systems, isdeveloping a TB test kit that the company hopes to market bythe end of next year, according to a company representative.Unlike the clinical testing services, diagnostics and test kits willrequire FDA marketing approval.

The reported cases of TB in the U.S. have been rising since1984, and treatment has been complicated by the emergence ofnew drug-resistant strains of the disease.

SKBCL's service combines PCR and DNA-probe technologies todetect M. tuberculosis and M. bovis, the most common causes ofthe disease. The company is working on assays to detect drug-resistant strains, said spokesman Tom Johnson. SKBCL providesclinical laboratory services nationwide through a network of 24regional facilities.

Roche agreed in mid-1991 to acquire for $300 million plusroyalties all rights to PCR technology held by Cetus Corp., whichdeveloped the technology that allows researchers to quicklymake millions of copies of a single DNA segment. Cetus wasitself acquired by its Emeryville, Calif., neighbor, Chiron Corp.,last December.

Roche licensed PCR technology to other clinical test laboratoriesbesides SKBCL, but none are obligated to disclose to Roche whatspecific disease applications they are targeting with testservices, a Hoffmann-La Roche spokesman said.

Roche officials have previously said the company was lookinginto developing PCR diagnostics for leukemia, cystic fibrosis,sickle cell anemia and microbacteria.

-- Ray Potter Senior Editor

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