Noridian GBA has issued the LCD for use of the Decipher Prostate Biopsy genomic classifier in patients with very low and low-risk prostate cancer.
The firm is preparing to launch a clinical trial for the AdxBladder test in the US early in 2019 and use the results to apply for 510(k) clearance with the FDA.
The microfluidics- and machine vison-based diagnostic may improve risk stratification of patients and reduce overtreatment, according to the company.
Excluding the impact of the one-time sale of patents last year, the company's revenues climbed 38 percent on strong product and service revenue growth.
The firm said it will use the funds to commercialize a blood-based proteomic test for identifying men with elevated PSA levels at high risk of prostate cancer.
The company is continuing to collect utility and cost effectiveness data for its SelectMDx test in reducing unnecessary procedures in men with signs of a possible prostate cancer.
LabCorp will be able to develop and commercialize the test for patients with an elevated PSA to determine their risk of having clinically significant prostate cancer.
Protein platforms revenues grew 21 percent, while biotechnology revenues were up 18 percent, and diagnostic revenues increased 2 percent.
The firm said it saw strong reimbursement for the Oncotype DX Breast Recurrence test and increased private payor reimbursement for its Genomic Prostate test.
Exosome markets a urine-based test called ExoDx Prostate (IntelliScore) to help determine whether patients with ambiguous PSA tests needs a prostate biopsy.