Cepheid is working on a replacement for the software used with its SmartCycler thermal cycler in clinical diagnostic applications after a customer identified a bug in the current version that can lead to "erroneous but believable results."
The company said in a statement that it has already notified customers of a "simple work-around" for the problem, and that in addition to the new, bug-free version of the software, it will also provide customers with additional software to identify assay runs that may have been affected by the bug.
Cepheid said in the statement that it "has notified its customers, business partners, distributors, and the proper regulatory authorities regarding the issue and these corrective actions."
The company said that software used for the SmartCycler in research applications and the software used with its GeneXpert real-time PCR platform "do not have the software function in question and are not involved in the customer corrective action."
Bill McMillan, senior vice president of development at Cepheid, told BioInform that the company's research software is "generally open" and allows users "to decide how to analyze data in a manual way." The diagnostic version of the software, however, contains a "closed component," which is where the bug was found. This version of the software is used with two SmartCycler-based tests that have been cleared by the US Food and Drug Administration for use as clinical diagnostics: the IDI-Strep B test to identify group B Streptococcus in pregnant women, and the IDI-MRSA test to detect methicillin-resistant Staphylococcus aureus.
The bug was related to a feature of the software called "check specimens," McMillan said, which automatically maps out where samples are placed in the instrument based on user input. While the software was generating correct results immediately after a run, the bug affected archived data in the system, and could cause "a shifting of results" for users who opted to run their analysis on archived data, McMillan said.
Such a bug in diagnostic software for this kind of instrument is "an extremely rare event," McMillan added, and requires the "intersection of three or four factors" in order to arise. Nevertheless, he noted, "the consequences could be bad" because customers who rely on their archived data "could get erroneous but believable results."
McMillan said that a Cepheid customer testing the MRSA assay first detected the bug and brought it to the company's attention. "We have a fix and we will take it out to the field," he said.
The company did not disclose how many customers were affected by the bug.
— Bernadette Toner ([email protected])