Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
And what "evidence" do you have to support your claim that Exact Sciences "managed to cherry pick the best possible results for the so-called Validation Study?
Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
News Alert!
The peer-reviewed medical journal "Gut" showed disappointing Septin 9 sensitivity, reducing the competitive threat to EXAS.
The publication entitled "Prospective Evaluatoin of Methylated SEPT9 in Plasma for Detection of Asymptomatic Colorectal Cancer" (availiable online Feb. 13th) showed:
Sensitivity for Cancer Stages 1-4: 35%, 63%, 46%, and 77.4% respectively.
Sample Size: 7,941 men (45%) and women (55%), mean age 60 years.
From the "Gut" publication:
"Our study using the blood based mSEPT9 test showed that CRC signal in blood can be detected in asymptomatic average risk individuals undergoing screening. However, the utility of the test for population screening for CRC will require improved sensitivity for detection of early cancers and advanced adenomas.
We believe that tests must show at least 50% sensitivity to meet guidelines published by the ACS and the Multi-Society Task Force on Colorectal Cancer."
Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
Your claims above regarding "cherry-picking" selected Cut Offs is completely bogus. It's called SPECIFICITY my friend and the SPECIFICITY for the FDA clinical trial is set at 90%.
You seem to be totally oblivious of the 1003 sample Validation Study that was presented at the American Molecular Pathology conference in Texas back in November of 2011 in which Cologuard showed 96% sensitivity for Stages 1-3 colon cancer overall, at a SPECIFICITY of 90%.
Try tuning into their quarterly conference call tomorrow morning at 10am in order to increase your knowledge base. You might learn something.
Biopharma Catalyst Trades To Watch For This Week [View article]
For example, the "Cut-Off" study conducted by EXAS was done with 1,003 samples, not 900 as the author states. It demonstrated a 98% Sensitivity (overall Stages 1-4) for CANCERS, not pre-cancers.
Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
PS. According to a 12/20 press release, Epigenomics will be conducting a rights issue against cash contributions for the amount of just under 5 million Euros (which allows them to be exempt from having to publish a "Prospectus" as is required by German securities laws). According to ECX, this "aims to extend the cash runway of the Company at least into Q4-2012."
One day later . . . the Company issued a press release stating that during the annual financial accounting review, the Executive Board of Epigenomics had recongized that a "cumulative loss of more than half of the nominal share capital of the company has been incurred. This is mainly attributable to budgeted losses from regular business operations but as well to higher than expected expenses in connection with the recently completed clinical study."
Question: If Epigenomics is such an attractive candidate to be acquired by the likes of a Big Pharma company like Abbott or Roche (as the author claims), then why do they have to institute yet another capital raise on their own, instead of attracting a capital injection from an interested partner?
Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
I would agree.
It's interesting to note that the author fails to highlight the fact that EXAS has published a "Cut-Off" study (to set their specificity at 90% for their current FDA clinical trial) at a recent AACR conference in which the results of a 1,003 patient case control study were presented. At a nominal specificity of 90%, the Exact Sciences test detected 98% of colorectal cancers and 83% of pre-cancers with high grade dysplasia. The test also demonstrated 57% sensitivity in the detection of advanced pre-cancers equal to or larger than 1 centimeter. The test's sensitivity increased with the size of pre-cancers, rising to 83% for pre-cancers larger than 3 centimeters.
It's puzzling why the author would leave out such a significant study - - - especially one that was standardized for general population screening unlike some of the Epi studies that we have seen in the past which showed substantial variability with no differentiation as to stage or adenoma size or dysplasia, not too mention a random general screening population study like that of Exact's current FDA clinical trial ("Deep C") which is using 12,700 samples.
What truly makes the Epi Pro test a non-starter for me is the fact that it has suffered from poor SPECIFICITY - - - high false positives.
The most recent Epi Pro Colon study showed only 71% sensitivity at 81% specificity. Good luck trying to get CMS reimbursement on a test that generates a false positive in 1 out of 5 tests. Meanwhile, that high false positive rate severely underperforms when compared to 98% for FIT!
Specificity is the probability of reporting negative when there is no cancer. So, for every 100 screening tests, FIT recommends only 2 unnecessary (and very expensive) colonoscopies for healthy patients, versus 19 for Epi, a huge difference.
This difference is magnified greatly when viewed as part of a program. For Epi, about half of healthy patients would be recommended for unnecessary colo after 3 screenings, and about two thirds after 5 screenings. This is not remotely economically viable, even ignoring looming competition from ColoGuard, which is vastly superior. It's unfortunate, but the author above seems to "gloss" over just how poor Epi performs when it comes to Specificity.
Interestingly enough, the author also fails to note the precarious cash position that Epi finds itself in. At the end of Q3 of 2012, Epigenomics had cash on its balance sheet of 6.2 million Euros, down from 14.0 million at the end of 2011. In fact, Epigenomics issued the following disclosure regarding their capital position on 07.11.2012
"Epigenomics’ current financial resources are not sufficient to support the company’s operations beyond the first quarter of 2013 and will force management to secure additional funds in the near future to remain operational in 2013 and beyond. Since it is not anticipated that the companywill be able to generate sufficient cash flows from licensing income or from product sales in the short term, Epigenomics is evaluating its options to raise capital in the markets before the end of 2012 using all means it has at its disposition, including issuance of shares and convertible bonds."
Meanwhile, Exact Sciences (http://bit.ly/Y9v9Tl) ended Q3 of 2012 with $118.6 million of cash on its balance sheet.
Top-Line FDA clinical trial results for their 12,700 patient "Deep C" study are due out in March.
9 High-Growth Healthcare Stocks With Bearish Stock Trends [View article]
The author doesn't have his stats straight.
EXAS does not have a float of 58.27 million shares. That is erroneous information. The Company did a 5.5 million share secondary back in August that raised another $53 million in cash. As a result, the current float is 63.77 million shares.
The shorts have been wrong about EXAS from $4.00 all the way up to the recent high at $12.30 The Company will announce FDA Clinical Trial Data for their Cologuard colon cancer screening test in March.
5 Healthcare Companies With Insider Buying During November 2012 [View article]
Don't let the paltry insider buys by the CEO and CFO of EXAS fool you. The CEO of EXAS owns 2.5 million shares via options. He's basically sending a "message" to shareholders with he and his CFO's purchase. The FDA clinical trial results have been pushed out by a mere 30-45 days ( to March ) in order to test all "normal" samples (roughly 12,000) during their clinical trial; thus the sell-off in the stock.
Way overdone in my mind, especially since the FDA need only see greater than 78% sensitivity to detection of colon cancer. Late last month, EXAS presented a study at the AACR conference in Anaheim that essentially sets the false positive rate (10%) for their upcoming cliical trial. The sensitivity to detect colon cancer on 1003 samples was 98%
Exact's non-invasive stool DNA test for the #2 killer of American's over the age of 50 that costs MediCare $14 BILLION per year, is a total "game-changer" in my opinion. It's a win-win for everyone, from the insurance companies to MediCare to the gastro doctors that perform colonoscopies.... who will see more business given that Exact's non-invasive test "Cologuard" will be getting more people screened, and more "positive" results will increase referrals for colonoscopy.
The management team at Exact Sciences is proven. Their last company (Third Wave Technologies) was acquired in 2007, ten months before FDA approval for the HPV screening test, Cervista.
Only Cervical cancer has essentially been eradicated in this Country (from 35,000 deaths annually to 4,000). Cologuard has a great opportunity at doing the same for colon cancer!
Waiting On Coal: Dynamics And Theory [View article]
Crude oil needs to drop substantially in order for Nat-Gas to get a better bid underneath it. 25% of nat-gas production comes from the drilling of OIL wells in the United States.
Waiting On Coal: Dynamics And Theory [View article]
You seem to be ignorant of the fact that the majority of China's iron ore producers have production costs of $100 per tonne, while the current iron ore Benchmark is trading at $90.00
That is a huge problem for this sector.
And it's interesting to note that (thus far) China has not done anything to re-stimulate. They are taking a wait and see game because they don't want to fan the fire of inflation and price the middle class right out of the real estate market... a market that has TONS of supply right now. And of course, there is the change in power occurring at year end too.
For Exact Sciences, Approval May Be The Easy Part [View article]
Cruelsister, thank you for the FACTUAL information. As opposed to the author, your brief presentation was most specific... especially in terms of potential competitors to Cologuard and their relative performance.
Again, I would hope that the author ( who claims to be bullish on Exact Sciences ) would present much more specific and factual data in the future on this Company. To simply throw out a "claim" that Exact "may have to surrender as much as 50% of the list price to the lab" without any supporting facts is just plain poor journalism. In fact, I don't know of any medical diagnostic test on the market today that has to give up 50% of its list price to a lab. That's just plain ludicrous, and has no basis in fact.
Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
Please be specific.
Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
The peer-reviewed medical journal "Gut" showed disappointing Septin 9 sensitivity, reducing the competitive threat to EXAS.
The publication entitled "Prospective Evaluatoin of Methylated SEPT9 in Plasma for Detection of Asymptomatic Colorectal Cancer" (availiable online Feb. 13th) showed:
Sensitivity: 48.2%
Advanced Adenoma Sensitivity: 11.2%
Specificity: 91.5%
Sensitivity for Cancer Stages 1-4:
35%, 63%, 46%, and 77.4% respectively.
Sample Size: 7,941 men (45%) and women (55%), mean age 60 years.
From the "Gut" publication:
"Our study using the blood based mSEPT9 test showed that CRC signal in blood can be detected in asymptomatic average risk individuals undergoing screening. However, the utility of the test for population screening for CRC will require improved sensitivity for detection of early cancers and advanced adenomas.
We believe that tests must show at least 50% sensitivity to meet guidelines published by the ACS and the Multi-Society Task Force on Colorectal Cancer."
Game over for Epigenomics.
Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
You seem to be totally oblivious of the 1003 sample Validation Study that was presented at the American Molecular Pathology conference in Texas back in November of 2011 in which Cologuard showed 96% sensitivity for Stages 1-3 colon cancer overall, at a SPECIFICITY of 90%.
Try tuning into their quarterly conference call tomorrow morning at 10am in order to increase your knowledge base. You might learn something.
Biopharma Catalyst Trades To Watch For This Week [View article]
Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
One day later . . . the Company issued a press release stating that during the annual financial accounting review, the Executive Board of Epigenomics had recongized that a "cumulative loss of more than half of the nominal share capital of the company has been incurred. This is mainly attributable to budgeted losses from regular business operations but as well to higher than expected expenses in connection with the recently completed clinical study."
Question: If Epigenomics is such an attractive candidate to be acquired by the likes of a Big Pharma company like Abbott or Roche (as the author claims), then why do they have to institute yet another capital raise on their own, instead of attracting a capital injection from an interested partner?
Epigenomics AG Vs. Exact Sciences: Who Wins The CRC Early Detection Fight? [View article]
It's interesting to note that the author fails to highlight the fact that EXAS has published a "Cut-Off" study (to set their specificity at 90% for their current FDA clinical trial) at a recent AACR conference in which the results of a 1,003 patient case control study were presented. At a nominal specificity of 90%, the Exact Sciences test detected 98% of colorectal cancers and 83% of pre-cancers with high grade dysplasia. The test also demonstrated 57% sensitivity in the detection of advanced pre-cancers equal to or larger than 1 centimeter. The test's sensitivity increased with the size of pre-cancers, rising to 83% for pre-cancers larger than 3 centimeters.
It's puzzling why the author would leave out such a significant study - - - especially one that was standardized for general population screening unlike some of the Epi studies that we have seen in the past which showed substantial variability with no differentiation as to stage or adenoma size or dysplasia, not too mention a random general screening population study like that of Exact's current FDA clinical trial ("Deep C") which is using 12,700 samples.
What truly makes the Epi Pro test a non-starter for me is the fact that it has suffered from poor SPECIFICITY - - - high false positives.
The most recent Epi Pro Colon study showed only 71% sensitivity at 81% specificity. Good luck trying to get CMS reimbursement on a test that generates a false positive in 1 out of 5 tests. Meanwhile, that high false positive rate severely underperforms when compared to 98% for FIT!
Specificity is the probability of reporting negative when there is no cancer. So, for every 100 screening tests, FIT recommends only 2 unnecessary (and very expensive) colonoscopies for healthy patients, versus 19 for Epi, a huge difference.
This difference is magnified greatly when viewed as part of a program. For Epi, about half of healthy patients would be recommended for unnecessary colo after 3 screenings, and about two thirds after 5 screenings. This is not remotely economically viable, even ignoring looming competition from ColoGuard, which is vastly superior. It's unfortunate, but the author above seems to "gloss" over just how poor Epi performs when it comes to Specificity.
Interestingly enough, the author also fails to note the precarious cash position that Epi finds itself in. At the end of Q3 of 2012, Epigenomics had cash on its balance sheet of 6.2 million Euros, down from 14.0 million at the end of 2011. In fact, Epigenomics issued the following disclosure regarding their capital position on 07.11.2012
"Epigenomics’ current financial resources are not sufficient to support the company’s operations beyond the first quarter of 2013 and will force management to secure additional funds in the near future to remain operational in 2013 and beyond. Since it is not anticipated that the companywill be able to generate sufficient cash flows from licensing income or from product sales in the short term, Epigenomics is evaluating its options to raise capital in the markets before the end of 2012 using all means it has at its disposition, including issuance of shares and convertible bonds."
Meanwhile, Exact Sciences (http://bit.ly/Y9v9Tl) ended Q3 of 2012 with $118.6 million of cash on its balance sheet.
Top-Line FDA clinical trial results for their 12,700 patient "Deep C" study are due out in March.
9 High-Growth Healthcare Stocks With Bearish Stock Trends [View article]
EXAS does not have a float of 58.27 million shares. That is erroneous information. The Company did a 5.5 million share secondary back in August that raised another $53 million in cash. As a result, the current float is 63.77 million shares.
The shorts have been wrong about EXAS from $4.00 all the way up to the recent high at $12.30 The Company will announce FDA Clinical Trial Data for their Cologuard colon cancer screening test in March.
4 Reasons Amarin Will Keep Tanking [View article]
Adam F already bashed CLSN.
Seems like an awful lot of risk there.
5 Healthcare Companies With Insider Buying During November 2012 [View article]
Way overdone in my mind, especially since the FDA need only see greater than 78% sensitivity to detection of colon cancer. Late last month, EXAS presented a study at the AACR conference in Anaheim that essentially sets the false positive rate (10%) for their upcoming cliical trial. The sensitivity to detect colon cancer on 1003 samples was 98%
Exact's non-invasive stool DNA test for the #2 killer of American's over the age of 50 that costs MediCare $14 BILLION per year, is a total "game-changer" in my opinion. It's a win-win for everyone, from the insurance companies to MediCare to the gastro doctors that perform colonoscopies.... who will see more business given that Exact's non-invasive test "Cologuard" will be getting more people screened, and more "positive" results will increase referrals for colonoscopy.
The management team at Exact Sciences is proven.
Their last company (Third Wave Technologies) was acquired in 2007, ten months before FDA approval for the HPV screening test, Cervista.
Only Cervical cancer has essentially been eradicated in this Country (from 35,000 deaths annually to 4,000). Cologuard has a great opportunity at doing the same for colon cancer!
Will 3M's Puzzling Acquisition Of Ceradyne Change Its Dividend Policy? [View article]
The author of this article doesn't seem to have a good grasp of what CRDN actually does.
Waiting On Coal: Dynamics And Theory [View article]
5 Cheap Basics With Vast Upside Due To Triple Whammy Of Good News [View article]
Waiting On Coal: Dynamics And Theory [View article]
Waiting On Coal: Dynamics And Theory [View article]
That is a huge problem for this sector.
And it's interesting to note that (thus far) China has not done anything to re-stimulate. They are taking a wait and see game because they don't want to fan the fire of inflation and price the middle class right out of the real estate market... a market that has TONS of supply right now. And of course, there is the change in power occurring at year end too.
For Exact Sciences, Approval May Be The Easy Part [View article]
As opposed to the author, your brief presentation was most specific... especially in terms of potential competitors to Cologuard and their relative performance.
Again, I would hope that the author ( who claims to be bullish on Exact Sciences ) would present much more specific and factual data in the future on this Company. To simply throw out a "claim" that Exact "may have to surrender as much as 50% of the list price to the lab" without any supporting facts is just plain poor journalism. In fact, I don't know of any medical diagnostic test on the market today that has to give up 50% of its list price to a lab. That's just plain ludicrous, and has no basis in fact.