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DiagnoCure Q1 Revenues Fall 12 Percent on Weak Sales of Hologic-marketed Prostate Cancer Assay

NEW YORK (GenomeWeb News) – Cancer diagnostics firm DiagnoCure said on Friday that revenues for the first quarter of its fiscal year 2014 decreased 12 percent year over year.

DiagnoCure's revenues are derived completely from royalties from the sale of the Progensa PCA3 assay for prostate cancer, marketed by Hologic, and the Quebec City-based company attributed the year-over-year revenue drop on Hologic's failure to promote and market the test.

Gen-Probe, acquired by Hologic in 2012, licensed the PCA3 gene from DiagnoCure in 2003 and developed the Progensa test. DiagnoCure said it is working to regain the rights to the PCA3 gene.

For the three months ended Jan. 31, the company's total revenues fell to C$146,969 ($133,000) from C$167,916 in the year-ago quarter. Revenues for both quarters were composed completely of license and royalty revenues.

DiagnoCure said in a statement that "quarterly worldwide sales of less than $2 million are not meeting [DiagnoCure's] expectations for a test whose value is supported by an ever-increasing number of clinical studies and publications."

The company added that "more resources need to be put into the sales and marketing of the Progensa test, and the product needs to be made available on an instrument platform more suitable to the prostate cancer diagnostic and screening market.".

Progensa is a urine-based molecular diagnostic assay that uses transcription-mediated amplification and runs on Hologic's family of Direct Tube Sampling systems. Canada cleared the assay for marketing in August 2011, while the US Food and Drug Administration approved it in early 2012.

DiagnoCure is pursuing the purchase of Hologic's entire prostate cancer business unit, and by regaining the rights to PCA3, it seeks to leverage its internal expertise to develop and commercialize a PCR-based version of the PCA3 test.

The firm said that it has generated data that demonstrates the PCR-based PCA3 test performs similarly to the current Progensa test.

"DiagnoCure's board of directors is pressing to resolve the current situation with Hologic to ensure that PCA3 gets the attention we believe it deserves," DiagnoCure Chairman Yves Fradet said in a statement.

In the meantime, the company saw its net loss in Q1 narrow to C$529,739, or C$.01 per share, from a net loss of C$788,237, or C$.02 per share, a year ago.

Its R&D costs decreased 41 percent to C$239,803 from C$404,859. Its general and administrative expenses were down 21 percent to C$403,001 from C$509,323.

DiagnoCure exited the first quarter with C$3.5 million in cash, cash equivalents, and short-term investments.