This urinary molecular test is conceived to help urologists in taking a enlightened decision towards the treatment of prostate cancer and to determine if a second biopsy is required for the patient who has already obtained a negative result from an initial biopsy. A way, therefore, to reduce the number of useless and costly biopsies for the healthcare systems.
For DiagnoCure, it was the third diagnotic test - following bladder and colon cancers - to succeed in reaching its way in the labyrinths of regulatory approvals and to acceed to the paying phase of commercialization. Seldom are small life sciences companies to achieve such a goal.
According to experts, the market targeted by the PCA3 test is more than 1 billion dollars US. Competition is barely inexistant, for the moment, for this test that bridges the gap between the 45 million PSA tests that are administered annually - in conjunction with rectal touching - to measure the specific antigen level of the prostate and repeated biopsies.
It is useful to recall that prostate cancer is the most frequent cancer amongst men. One American on six is subject to it and one man on 46 will die of it.
EXCEPTIONAL "Agreement"
One month later, DiagnoCure always see the way of this promise land. The waiting of it seems however much more complicated than planned.
The present situation is very frustrating and totally out of our control, says Dr. Fradet, co-founder, president and chief - medical affairs of the company, listed on the stockmarket (TSX : CUR, 0,30 $).
On August 1, 2012, DiagnoCure's partner Gen-Probe - who invested more than 50 million $ since 2003 to achieve clinical studies and to pay the costs linked to PCA3 - was acquired my multinational Hologic for 3.7 billion $US.
This American giant makes its fortune in the products related to the health of women. It is namely a supplier of Pap tests for the cancer of the uterus and mammographies equipments.
In an interview with LE SOLEIL (newspaper), Dr. Fradet indicates that Hologic relays very little information to its Quebec partner in regard to the commercialization strategy of PCA3. We are not in the secrets of God and Hologic does not inform us of their plan, confides Dr. Fradet, who assures that there was a "strong interest" in the medical community for the use of the PCA3 test already commercialized in Europe.
Doctors know that the PCA3 exists. We must nowon convince them to use it. All what it take, is a some investment and a bit of commercialization.
The actual situation is further more deceptive that DiagnoCure believes it has an exceptional agreement with its partner (Hologic).
Indeed, the Agreement provides that the Quebec biotech - which saw the day in 1994 - will receive royalties of 8% on the sales of PCA3 tests until they reach 62 million US$. Once the sales reaches above this amount, the percentage of royalties will rise to 16%. In February 2012, the sales were already at 27 million US$.
The financial situation of DiagnoCure is not catastrophic but it is obvious that it would largely benefit of a more agressive PCA3 commercialization on the part of Hologic.
At the end of the third quarter, on July 31, 2012, the company had a net loss of $600,000.00 compared to a net loss of $900,000.00 for the same period in 2011.
DiagnoCure recorded revenues of nearly $710,000.00 compared to a little over $290,000.00 for the same period in 2011. Revenues stemming from royalties paid by its partners for the sale of diagnostic tests et installment payments allowed the company to have 6.4 million $ in treasury.
Obviously, precaution is at stake in current circumstances. We preserve our cash while still being active. And we must keep a minimum of employees. We now have 13 employees. We are at the ADN stage for DiagnoCure, concludes Dr. Yves Fradet.