Originally published Oct. 11.
By Turna Ray
Yonkers, NY-based Aureon Biosciences has ceased operations and laid off all 95 of its employees, according to a notice filed last week with the New York State Department of Labor.
Aureon markets two laboratory-developed prognostic tests for prostate cancer: Post-Op Px, a test that gauges patients' likelihood of post-prostatectomy disease recurrence by assessing cellular, clinical, and molecular factors; and Prostate Px+, a tissue-based test that assesses whether a patient's disease is likely to metastasize and therefore should be treated aggressively. Post-Op Px was launched in 2006, and Prostate Px+ became available as an LDT in 2008.
The company didn't respond to telephone requests for interviews and e-mails to a company official bounced back.
According to documents filed with New York's Worker Adjustment and Retraining Notification program, Aureon closed its office and lab in Yonkers on Oct. 4, citing "economic" reasons.
The privately held company has not disclosed its financial statements, but it appears that it may have faced difficulty securing reimbursement for its tests. For example, a medical policy document issued in March from Regence, a Blue Cross Blue Shield contractor, states that the "value" of the company's so-called "systems pathology approach" to determine prostate cancer recurrence risk "is not known based on currently available studies. Thus, the impact on clinical outcomes is not known and the clinical utility of this testing is not known."
Despite the financial roadblocks Aureon appears to have faced, a number of other companies have identified prostate cancer recurrence risk as a promising area for molecular diagnostics. For example, Iris International recently gained 510(k) clearance from the US Food and Drug Administration for its Nadia ProsVue test, which combines immunoassay and real-time PCR methodologies to determine the risk for recurrence of prostate cancer for eight years after prostatectomy.
Genomic Health is also developing a test, slated for launch in 2014, that has been shown in clinical studies to be a promising tool for identifying which prostate cancer patients have indolent disease and can be managed with surveillance, and those who have aggressive cancer and should receive surgery or radiation therapy.
Genomic Health has been among the most successful firms in the industry in gaining reimbursement for its tests, particularly for the Oncotype DX breast cancer recurrence test.
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