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| Roland Diggelmann, COO of Roche Diagnostics Global--Courtesy of Roche |
Roche ($RHHBY) got an FDA CLIA waiver for its rapid Strep A test, opening the door to expanded use of the product months after the agency signed off on the test. The company's cobas Strep A test and PCR system detects bacteria from throat swab specimens in about 15 minutes, offering an advantage over traditional screening methods which often come with lengthy processing times and additional testing, Roland Diggelmann, COO of Roche Diagnostics, said in a statement. The FDA CLIA waiver allows the test to be used across a variety of clinical settings, including doctors' offices, emergency rooms and pharmacy clinics. "Today's decision allows the cobas Strep A test to be utilized in clinical settings that previously relied on rapid antigen technology, which is less sensitive and often requires confirmatory testing," Diggelmann said. "The 15-minute turnaround time of the cobas Strep A test offers a much improved experience for both the patient and health care professional when compared to culture testing, which can take several days for a result." Release | More