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Roche Receives FDA Clearance for Cobas BKV Test for Use With Urine Samples

NEW YORK – Roche announced Thursday that its Cobas BKV test received 510(k) clearance from the US Food and Drug Administration for use with stabilized urine samples.

The test was previously cleared for use with ethylenediaminetetraacetic acid (EDTA) plasma samples. There are often higher BK polyomavirus DNA levels in urine before plasma, which can be an early predictor of an impending infection, the company said in a statement. The urine sample should be stabilized in Cobas PCR media, allowing the integrity of the results to be maintained and making storage and transportation easier because there is no need for refrigeration, Roche continued. 

Roche's fully automated RT-PCR test can help manage BK virus in transplant patients and runs on the Cobas 6800 and 8800 systems. According to the company, the test with urine samples has a limit of detection of 12.2 international units per milliliter and a linear range from 200 IU per milliliter to 1E+08 IU per milliliter. 

It also has CE marking for use with EDTA plasma samples and urine stabilized in Cobas PCR media, the company said. BKV can cause significant transplant-associated complications and can be present without symptoms, potentially causing nephropathy in kidney transplants and hemorrhagic cystitis in hematopoietic stem cell transplants, Roche said.