|Cepheid won FDA clearance for its combo tuberculosis diagnostic.--Courtesy of Cepheid|
California's Cepheid ($CPHD) secured the FDA's blessing to market its Xpert MTB/RIF assay, the U.S.'s first test that can detect both bacteria that cause tuberculosis and whether a patient's strain is resistant to antibiotic therapy.
The test, used with Cepheid's GeneXpert analysis systems, can identify Mycobacterium tuberculosis complex in patient DNA, and, in positive cases, determine whether first-line antibiotic rifampin will have any benefit. Current methods of determining TB's drug-resistance take about three months, but Cepheid's test churns out results in just two hours, the company said.
"Xpert MTB/RIF is the most technologically advanced test for TB ever developed, yet it is simple enough to be performed across multiple shifts in laboratories across the country," Chief Medical and Technology Officer David Persing said in a statement.
While TB is hardly the scourge it was 100 years ago, it remains a major concern among the elderly and other patients with compromised immune systems, and Cepheid's test is quick and versatile enough to make a difference for at-risk populations, FDA diagnostics director Alberto Gutierrez said.
"Less complex tests such as the Xpert MTB/RIF assay can be used in more diverse settings," Gutierrez said in a statement. "The early and rapid detection of rifampin-resistant TB can help curb the spread of drug-resistant TB, a major public health threat."
The FDA cleared Xpert through its de novo 510(k) program, a process set aside for devices and diagnostics that aren't substantially equivalent to anything on the market but not risky enough to warrant the full pre-market approval system.
- read Cepheid's announcement
- check out the FDA's statement