This past Wednesday DiagnoCure (TSX:CUR), along with its US-based partner Gen-Probe, received FDA approval for its lead prostate cancer diagnostic biomarker PCA3, which will be branded as Progensa.
Byron Capital Healthcare and Biotech analyst Douglas Loe says this news signals a new era in Diagnocure’s history. In a research update last week, Loe upgraded Diagnocure to Buy from Speculative Buy because he says the company is no longer as subject to clinical or regulatory risk. The Byron analyst also raised his target price to $2.75 from $2.00, which he says he arrived at by reducing his valuation discount to 25% from 40%.
Sainte-Foy’s Diagnocure, which was founded in 1994, thinks molecular diagnostics tests can detect irregular gene or protein activity patterns associated with cancer. The company says PCA3 gene testing may help urologists identifying prostate cancers. In the clinical study, the Progensa PCA3 predicted a negative prostate biopsy with 90% accuracy. Blood-based PSA testing for prostate cancer is nowhere near as accurate, says Loe, and this leads to a a high rate of unnecessary, and costly, biopsies.
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Loe believes that, because US diagnostic and regulatory standards are higher than other regions, the FDA approval could almost immediately mean approval in more markets. He thinks Diagnocure will sell just under 19,000 tests this year at (US)$85 dollars per test. He believes PCA3-based revenue will bring Diagnocure to profitability in 2013, and that revenue will nearly triple, to $22.2 million, by 2016.
The American Cancer Society says prostate cancer is the second most common type of cancer found in American men, after skin cancer, and the second-leading cause of cancer death in men, after lung cancer. One in six American men will get prostate cancer during his lifetime and one in thirty-six will die from it. Diagnocure management says the market for molecular diagnostic testing is forecast to grow at more than 30% per year, reaching (US) $4 billion by 2014.
Shares of Diagnocure closed Friday down 5% to $.95 cents.
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