|The Xpert MTB/RIF test--Courtesy of Cepheid|
Cepheid ($CPHD) says it gained a key "moderate complexity" CLIA designation for its new combo TB test, helping to position the diagnostic to reach the broadest possible market.
The FDA categorization comes under the Clinical Laboratory Improvement Amendments and affects the California company's Xpert MTB/RIF test. Regulators approved the assay in July under their de novo 510(k) program, making it the first in the U.S. approved to detect both bacteria that cause tuberculosis and also whether a patient's particular strain resists antibiotics.
"The 'Moderate Complexity' categorization of Xpert MTB/RIF will allow a broad range of healthcare facilities access to actionable results in approximately two hours instead of weeks," Cepheid Chairman and CEO John Bishop said in a statement.
Usually, traditional tests to detect drug-resistant TB take one to three months.
Xpert MTB/RIF is made for use on Cepheid's GeneXpert Systems, and it helps detect Mycobacterium tuberculosis complex in patient DNA. For patients who test positive, it can also identify whether they will benefit from the antibiotic rifampin or if they have a drug-resistant variety of TB that requires more intensive treatment.
TB remains an issue with older patients and folks with compromised immune systems (and it continues to assault the developing world). With this in mind, the company hopes to make a splash with its test, which is designed to be both quick and versatile. Earlier and speedier detection of what kind of TB is at play will help develop more targeted, and prolonged, treatments for those who need them.
- read the release