Quote from jimmyjazz:
I did my due diligence, but it apparently wasn't diligent enough. I am amazed at how often I learn just how much I don't know.
I have been a long-term investor in shares of EXAS since 2007 and have listened to every quarterly conference call since. The new management team that came in in March of 2009 has worked miracles and completely optimized this non-invasive stool DNA screening test for colon cancer. (the previous Clowns that ran the Company had no clue what they were doing and tried to back-door the FDA by developing an LDT "Lab Only" test which is basically worthless because you are not able to obtain CMS reimbursement and you are not allowed to advertise or market it).
Cologuard by EXAS will not only detect colon cancer at a very high sensitivity and specificity ( low false positive rate ) but it will also identify pre-cancerous polyps as well.
It is downright mind-boggling to see the lack of knowledge base about EXAS, with people here comparing it to DNDN and other drug/pharma concerns.
This is a medical DIAGNOSTICS company that is about to complete it's clinical trial.... running 10,800 samples thru 3 labs in a blinded study. This is not a company that is developing a DRUG and having to go through Phase 1, 2, or 3.
CMS (Medicare) has also invited them to enter a parallel pilot program that allows EXAS to obtain CMS reimbursement within 90 days of FDA approval. This is a HUGE advantage given that the normal process usually sees CMS reimbursement 18-24 months AFTER FDA approval.
The Company expects to launch in Q1 of next year.
They had $108 million in cash on the balance sheet at the end of 2012 and have one of the sharpest management teams around. The CEO/CFO's last company (Third Wave Technologies) developed an HPV screening test that they wound up selling to HOLX 10 months before FDA approval for $580 million. That test, called Cervista has since gained 40% market share and is highly complimentary to the Pap Smear, given that the majority of cervical cancer comes from the HPV virus.
There is a tremendous amount of info that can be learned by just listening to the recent quarterly conference call from late February.
It only takes about 30 minutes if you aren't lazy.
There was also a good article in early October 2012 in Barron's that highlighted the company.
I believe that the FDA has stated that they only need to show 78% or greater sensitivity for detecting cancer. There is no threshold for detecting pre-cancers. The Company has gone thru 3 different validation studies and the last one that included 1003 samples had sensitivity well over 90% with a specificity set at 90%. Corporate guidance has been > 85% for cancer detection and >55% for pre-cancers.
Their partner is the Mayo Clinic and Dr. David Ahlquist.
His team is also working on DNA methylation markers to detect pancreatic cancer.
Last year, a basic blood screening company that screens for STD's and Hepatitis called GenProbe was bought out for $3.5 BILLION by HOLX. Much of the diagnostic testing that was developed there was done by none other than current EXAS senior research scientist, Graham Lidgard.
If you were to put a $3.5 Billion dollar market cap on EXAS, you are close to $55 per share.
I believe that this Company is going to be one of the greatest stories (ever) in Medical Diagnostics.... and will go an awful long way to eradicating the #2 killer of Americans over the age of 50, that costs Medicare $14 BILLION annually!
The Cologuard test from EXAS will undoubtedly replace the FOBT/FIT test that does nothing but detect blood in one's stool. If you have blood in your stool AND it's from cancer, you are probably already in Stage 2.
By the way, there are 10.4 million annual FOBT/FIT tests undertaken annually. Multiply that by the $300-$500 price tag for Cologuard (which will be recommended once every 3 years) and you can see that this is a Company that will be generating BILLIONS in sales in the US alone.
Don't be so f-ing lazy.
Do your own due-diligence and listen to a few of the corporate presentations on the EXAS website and/or their most recent earnings call in late February.
The Big Boys aren't even involved in this stock yet.
The "back of the napkin" numbers are off the charts.
Cologuard is going to be a "game-changer".
Hope this helps.
