Cepheid announced that its new TB test received market authorization from the U.S. Food & Drug Administration (FDA). FDA has recently categorized its Xpert MTB/RIF test as 'Moderate Complexity' under the Clinical Laboratory Improvement Amendments (CLIA). The test runs on the GeneXpert Systems and is the first ever molecular TB test to achieve such a break through mark.
Xpert MTB/RIF test is so designed that it will not only help in rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA, but also mutations associated with rpoB gene that build resistance to rifampin, a first line drug prescribed for the treatment of the disease. This enhanced feature is deemed to be beneficial for patients with multi drug resistant TB, requiring a more intensive and perpetual mode of treatment.
As early detection of the disease stands a challenge to the clinicians, the new test promises to generate results within 2 hours, much faster than the usual 6 weeks taken by standard laboratory methods. This explains FDA’s categorization, based on the reduction of time taken for diagnosis. This major throughput will also equip clinicians in the U.S. to guide therapy decisions in the early stages of the disease, providing better patient outcomes in the long run.
Xpert MTB/RIF test is particularly relevant in early diagnosis of the disease as symptoms pertaining to TB can often be misleading, resulting in erroneous treatment. Moreover, it is estimated that currently, one third of the human population is infected with the disease, but most do not have active disease that requires treatment. The company expects to deliver quality medical solutions through its Xpert MTB/RIF test to overcome the shortcomings associated with diagnosis of this disease in the U.S.
Though the test is categorized as Moderately Complexity, it is believed to be simple enough that can be implemented across multiple shifts in laboratories throughout the country. Xpert MTB/RIF is currently available for shipment in the U.S.
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