Nucleix Expands EU Label Indication for Bladder Cancer Urine Test

Original from: 360DX

Israeli diagnostics firm Nucleix said on Wednesday that it has expanded the European Union label indication of its Bladder EpiCheck urothelial cancer test.

Bladder EpiCheck measures DNA methylation patterns in urine and was originally launched to monitor tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. 

Under the updated label, the test may also be used to aid in the detection of primary bladder cancer and upper tract urothelial carcinoma (UTUC) in patients presenting with hematuria, other urinary tract symptoms, or findings indicating malignancy, according to Nucleix. The new label also includes the detection of recurrent UTUC in conjunction with standard diagnostic procedures.

"The current workup of hematuria is invasive, costly, and usually performed too late due to delayed referrals to urologists, all the while symptoms can worsen and diagnosis of the disease is delayed when treatment is critical," Eli Frydman, president of Europe, Middle East, and Africa at Nucleix, said in a statement. "With this expanded label indication and high specificity of Bladder EpiCheck in this population, we’re able to offer a cost-effective, noninvasive approach to triage hematuria patients and help identify bladder cancer early."

Nucleix, which raised $77 million last year, is awaiting US Food and Drug Administration clearance for Bladder EpiCheck.

Source: Nucleix Expands EU Label Indication for Bladder Cancer Urine Test