Hi Gary,
"the company's new gene-based molecular diagnostic test for prostate cancer,which has successfully completed it’s Phase III double-blind clinical trial and is now ready for commercialization by Clarient."
I've been scratching my head in regard to this report. As much as I would like it to be true, it doesn't stand up to my DD & personal experience.
The Clarient's tissue test has already been validated as a Lab Developed Assay (LDA) at the end of 2008, but according to my two discussion with Clarient and one with HDC, it's not available yet. HDC admitted that Clarient wasn't their best choice of partners. I agree with that. It's a great small niche anatomical pathology lab with the type of leadership I would invest hard earned money on, but they don't have the resources - only a handful a sales reps. Also, they've only been profitable for a year.
According to Clarient, they are too small to vet this new technology (hello Quest and Abbott) and need to stick to their core testing (K-ras and EFRG was mentioned). This "space" is very competitive and small players need to stick to the old stalwart testing.
Now, the report might indicate that Clarient is finally ready to commit to its launch, but the terminology seemed to be from an old press release, so the rational part of me says "nah."
I really hope this move isn't related to that report, but the knowledge of an announcement of Quest (and/or a leak) is forthcoming. I've said multiple times that the Quest LDA should be out by Q1 2010 based on my industry experience and the FDA another year after that (if not more). The Quest LDA will be absolutely industry-shattering. More so that the OVA1, since the HDC test is "routine" and shooting for "standard of care," and the Prostate is a much larger market than Ovarian cancer (again, I always feel sleazy monetizing cancer). The Abbott FDA kit will be another windfall for HDC since it could than be sold to every commercial, hospital outreach and research laboratory in the world.
And we still have other irons in the fire. One that is really under the radar is the DCL collaboration; DCL being the "jewel cytology lab in the Midwest." Nothing clinical-lab-related generates more revenue than cervical cancer (Cytology - Imaged Guided/Computer Enhance Liquid Based Pap Smears & histology).
Either way, should be an interesting week.