NEW YORK (GenomeWeb News) – Cepheid is recalling its blood culture-based MRSA test after some researchers reported getting inconclusive results, but investment analysts called the suspension of sales of the test "immaterial."
The Sunnyvale, Calif.-based molecular diagnostics firm sent a letter to customers this week saying it was suspending the sale of its Xpert MRSA/SA BC test after some researchers reported abnormally high invalid rates causing them to re-run the test.
There have been no adverse patient events reported and Cepheid has not been able to duplicate the same invalid results internally, but the firm is taking the test off the market as it evaluates it and re-optimizes it, and possibly seeks re-approval from the US Food and Drug Administration. The test could be reintroduced later this year.
The MRSA/SA-BC test is specifically used for blood cultures. Cepheid's other Xpert tests, including its core MRSA test, Xpert MRSA, which uses nasal swabs, are not affected by the recall.
The company does not expect the recall to materially impact its business for 2012. Two investment banks agreed and issued notes saying the Xpert MRS/SA BC test makes up only a small part of Cepheid's revenues.
Isaac Ro of Goldman Sachs estimated that the test accounts for less than 2 percent, or about $4 million, of the company's total revenues in 2011. The test had a Class I recall by the FDA in 2010 due to false negative results, which he said was significantly more troubling since that could lead to patient deaths.
"An inconclusive result, as is the case here, is far more benign," he said, but added, "Nevertheless, questions behind the multiple issues for this product are fair and we assume the product will have to re-obtain FDA approval."
Quintin Lai of R.W. Baird also said in a research note he expects no material impact from the recall and added that during the recall customers will still be able to use cartridges for the test they already have and report their results.
He also noted the earlier Class I recall of the test and said that that incident "had low impact" on Cepheid's financial results then.