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Amarin Corporation plc Message Board

marsala1234 395 posts  |  Last Activity: Jul 5, 2016 10:52 AM Member since: Jan 31, 2003
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  • Reply to

    reason for todays drop UNH

    by marsala1234 Jul 5, 2016 10:23 AM
    marsala1234 marsala1234 Jul 5, 2016 10:52 AM Flag

    While looking at the site I saw this:

    Computed tomographic colonography is proven and medically necessary for any of the following:
    • As a diagnostic tool for symptomatic patients who are unable to undergo a complete colonoscopy (such as individuals with an obstructive tumor and others who may be unable to tolerate the procedure)
    • Patients on anticoagulation therapy who cannot safely discontinue treatment and would be at risk of bleeding from a more invasive procedure
    • As a screening test for colon cancer

    So CT colonography is OK for screening even though it wasn't recommended by USPSTF and there is no evidence it reduces the likelihood of reducing CRC mortality - the reasoning they gave for not supporting CG. Sounds political or that Exact and UNH haven't had the best of negotiations. Doesn't make much clinical sense.

  • marsala1234 by marsala1234 Jul 5, 2016 10:23 AM Flag

    July 1 2016: form UHC provider medical policy site
    Fecal DNA testing for colorectal cancer screening and/or monitoring is unproven and not medically necessary.
    There is insufficient published evidence in the clinical literature supporting the diagnostic accuracy of fecal DNA tests to screen for colorectal cancer in asymptomatic, average-risk patients. The gold standard for colorectal cancer screening is optical colonoscopy. There is insufficient published evidence comparing fecal DNA testing to optical colonoscopy. In fact, there is insufficient published clinical evidence that fecal DNA testing reduces the likelihood of mortality from colorectal cancer
    The National Comprehensive Cancer Network (NCCN) states that emerging technologies such as stool DNA have shown increasing evidence as a reasonably accurate screening test, but there is limited data to determine the optimal testing interval. Stool DNA testing is not recommended as a primary screening modality at this time (NCCN, 2015).The U.S. Preventive Services Task Force (USPSTF) recommendation on screening for colorectal cancer (CRC) concludes that evidence remains insufficient to assess benefits or harm for fecal DNA testing as a screening modality for CRC (USPSTF, 2015).

    Very interesting that they don't include the new USPSTF guidelines in their review. This is OLD info and they will be obligated to cover in the next 12 months.

  • Reply to

    CDC press release 6/24

    by marsala1234 Jun 29, 2016 3:24 PM
    marsala1234 marsala1234 Jun 29, 2016 3:37 PM Flag

    Sorry-Actually 4.7 million every 3 years (or yearly if 30% of fit market)

  • marsala1234 by marsala1234 Jun 29, 2016 3:24 PM Flag

    CDC researchers estimate that U.S. health care facilities have the capacity to meet the National Colorectal Cancer Roundtable’s goal of screening at least 80% of adults aged 50 to 75 years for colorectal cancer by 2018.
    The model showed that if a program using FIT as the primary screening method was implemented, 47 million FITs and 5.1 million colonoscopies would be needed each year by 2024. If a program using colonoscopy as the only screening method was implemented, 11 to 13 million colonoscopies would be needed per year.

    So lets say conservatively CG could get 10% of the FIT tests in this model. I'll take 4.7 million tests a year x an average of $400+ test.

  • marsala1234 marsala1234 Jun 9, 2016 12:47 PM Flag

    You might be right that 240k is built in, but I don't think the street believes KC's estimates to start growing 30% quarter over quarter after the relatively flat past 3 quarters. Personally, I'd be happy to see 240K at this point.

  • marsala1234 marsala1234 Jun 9, 2016 11:59 AM Flag

    Buyer - the fact that they have maintained the 240K test expectation when the street is around 210K is in my mind guidance that testing is accelerating, because to meet 240K testing will have to hit around 150K for Q3 and Q4 combined vs 90K the first half of the year. They must have some visibility they are not specifically sharing yet. (I hope!)

  • Gastroenterology. 2016;150(2):396-405.

    Methods: We collected data from 438 men who underwent screening or surveillance colonoscopies and then repeat colonoscopy examinations within 60 days by a different blinded endoscopist (1161 colon segments total) at the West Haven Veterans Affairs Medical Center from January 2014 to February 2015. Missed polyps were defined as those detected on the second examination of patients with the best possible bowel preparation (colon segment BBPS score of 3) on the second examination.

    Results: The adjusted proportion with missed adenomas greater than 5 mm was noninferior for segments with BBPS scores of 2 (5.2%) vs those with BBPS scores of 3 (5.6%) (a difference of -0.4%; 95% confidence interval [CI], -2.9% to 2.2%). Of study subjects, 347 (79.2%) had BBPS scores of 2 or greater in all segments on the initial examination. A higher proportion of segments with BBPS scores of 1 had missed adenomas larger than 5 mm (15.9%) than segments with BBPS scores of 3 (5.6%) (a difference of 10.3%; 95% CI, 2.7%–17.9%) or 2 (5.2%) (a difference of 10.7%; 95% CI, 3.2%–18.1%). Screening and surveillance intervals based solely on the findings at the first examination would have been incorrect for 16.3% of patients with BBBPS scores of 3 in all segments, for 15.3% with BBPS scores of 2 or 3 in all segments, and for 43.5% of patients with a BBPS score of 1 in 1 or more segments.

    Conclusions: Patients with BBPS scores of 2 or 3 for all colon segments have adequate bowel preparation for the detection of adenomas larger than 5 mm and should return for screening or surveillance colonoscopy at standard guideline-recommended intervals. Colon segments with a BBPS score of 1 have a significantly higher rate of missed adenomas larger than 5 mm than segments with scores of 2 or 3. This finding supports a recommendation for early repeat colonoscopic evaluation in patients with a BBPS score of 0 or 1 in any colon segment.

  • marsala1234 marsala1234 Jun 2, 2016 11:30 PM Flag

    Ranjo- could be an exciting (or punishing) end of summer with a USPSTF decision and Reduce It results - good luck long timer!

  • Early results from a European trial of colonoscopy has two important lessons for the practice

    The lessons from the NordICC study, preliminary results on practical points of performing colonoscopy, were published online May 23 in JAMA Internal Medicine. (However, data on the primary end points of colorectal cancer mortality and incidence will not be available for another 8 years or so.)
    The study involved 94,959 patients identified as eligible from population registries in Norway, Poland, Sweden, and the Netherlands;
    The study showed that colonoscopy could be performed successfully without sedation, and that insufflation with carbon dioxide rather than air could significantly reduce postprocedure abdominal pain.

    2 thoughts:
    1) CG is way simpler and less painful
    2) Nordic folks and Pols are way tougher than your average American who won't go without a Propofol cocktail!!

  • Reply to

    DDW Presentations....

    by sailingaway82 May 25, 2016 11:28 AM
    marsala1234 marsala1234 May 25, 2016 1:58 PM Flag

    Sailing - can you supply details or a link to find it? Can't see it on DDW site for some reason. Thanks

  • Reply to


    by ivangreenberg May 18, 2016 4:32 PM
    marsala1234 marsala1234 May 18, 2016 4:36 PM Flag

    you are probably aware that home FOBT is not Cologuard?

  • Reply to

    My PCPs Comment

    by marvls_one May 17, 2016 1:27 PM
    marsala1234 marsala1234 May 17, 2016 2:00 PM Flag

    Marvis- you make a very good point. The harder it is for a busy doctor to order CG the less likely it will be done. Maneesh talked about that in the last earnings call. They are trying to allow CG to be ordered from a dropdown menu on the EHR so it can be electronically processed (as well as the result). This will be a big improvement but it's a long haul as there are so many different EHR's to work with.

  • Reply to

    What will make their revenue per test increase 12%

    by acasmaker May 17, 2016 11:14 AM
    marsala1234 marsala1234 May 17, 2016 1:23 PM Flag

    acas-" If tests do not grow by at least 20% they will never come close to meeting guidance"
    That's true. But they had 40k in Q1 and KC already said they will hit 48K in Q2 - that's 20%. You can count on that as they have good visibility already being in Q2. It's Q3 which is key as we will need to see growth around 30% for the next 2 quarters to hit 240k.

  • Reply to

    Easily the most important earning call to date.

    by sstephanc May 3, 2016 2:01 PM
    marsala1234 marsala1234 May 3, 2016 3:41 PM Flag

    Martin - the docs like CG. Most docs don't know AHRQ from HEDIS to NCQA from a hole in the wall. What they do know is that a patients insurance may or may not cover CG and that is a barrier to ordering. Insurers care about HEDIS because they get rewarded or punished based on HEDIS scores. So, they are reluctant to cover a test if it doesn't "count" towards a "hit" on the HEDIS measure. Once CG is included in the NCQA HEDIS measurement more insurers will come on board and therefore more providers will order the test. This whole process is moving slower since the USPSTF decision but I believe we will get there.

  • Reply to

    Easily the most important earning call to date.

    by sstephanc May 3, 2016 2:01 PM
    marsala1234 marsala1234 May 3, 2016 3:12 PM Flag

    Agree Highscorer. 40k first quarter. I predict they beat by a little so 50K 2nd qtr. That means they have to average 75k for the 3rd and 4th qrt. to hit 240k. (maybe 65k and then 85k). That's a heavy lift. The street doesn't think they can do it. If they do it would be quite an accomplishment and we will be rewarded.

  • Reply to

    new meatanalysis FIT/FOBT

    by marsala1234 Apr 27, 2016 3:26 PM
    marsala1234 marsala1234 Apr 27, 2016 3:50 PM Flag

    Sorry the Meta-analysis conclusion was cut off:

    "Conclusion Faecal occult blood tests, both guaiac- and immunochemical-based, show better diagnostic performance for the relative detection of colorectal cancer in the distal colon than in the proximal bowel."

    Nothing new to us but the more folks know this problem with FIT and that CG gets proximal lesions as well as distal lesions the better.

  • marsala1234 by marsala1234 Apr 27, 2016 3:26 PM Flag

    Aliment Pharmacol Ther. 2016;43(7):755-764.

    Abstract and Introduction


    Background The performance of faecal occult blood tests (FOBTs) to screen proximally located colorectal cancer (CRC) has produced inconsistent results.

    Aim To assess in a meta-analysis, the diagnostic accuracy of FOBTs for relative detection of CRC according to anatomical location of CRC.

    Methods Diagnostic studies including both symptomatic and asymptomatic cohorts assessing performance of FOBTs for CRC were searched from MEDINE and EMBASE. Primary outcome was accuracy of FOBTs according to the anatomical location of CRC. Bivariate random-effects model was used. Subgroup analyses were performed to evaluate test performance of guaiac-based FOBT (gFOBT) and immunochemical-based FOBT (iFOBT).

    Results Thirteen studies, with 17 cohorts, reporting performance of FOBT were included; a total of 26 342 patients (mean age 58.9 years; 58.1% male) underwent both colonoscopy and FOBT. Pooled sensitivity, specificity, positive likelihood ratio and negative likelihood ratio of FOBTs for CRC detection in the proximal colon were 71.2% (95% CI 61.3–79.4%), 93.6% (95% CI 90.7–95.7%), 11.1 (95% CI 7.8–15.8) and 0.3 (95% CI 0.2–0.4) respectively. Corresponding findings for CRC detection in distal colon were 80.1% (95% CI 70.9–87.0%), 93.6% (95% CI 90.7–95.7%), 12.6 (95% CI 8.8–18.1) and 0.2 (95% CI 0.1–0.3). The area-under-curve for FOBT detection for proximal and distal CRC were 90% vs. 94% (P = 0.0143). Both gFOBT and iFOBT showed significantly lower sensitivity but comparable specificity for the detection of proximally located CRC compared with distal CRC.

    Conclusion Faecal occult blood tests, both guaiac- and immunochemical-based, show better diagnostic performance for the relative

  • Reply to

    Blood test approved by the FDA

    by biostigg Apr 13, 2016 7:09 AM
    marsala1234 marsala1234 Apr 14, 2016 5:15 PM Flag

    From the FDA:
    "Regarding whether or not the test is effective, five panel members voted yes, and six, no. Regarding whether or not its benefits outweigh its risks, five panel members voted yes; four, no; and one abstained.

    At the time, several panel members voiced concern about use of the Epi proColon test for screening, especially insofar as the test failed to perform better than the fecal immunochemical test (FIT)."

    Quite the overwhelming endorsement- not.

  • Reply to

    FDA approval of Epi proColon

    by sstephanc Apr 13, 2016 9:52 AM
    marsala1234 marsala1234 Apr 13, 2016 5:35 PM Flag

    Like minds Sailing LOL!

  • Reply to

    FDA approval of Epi proColon

    by sstephanc Apr 13, 2016 9:52 AM
    marsala1234 marsala1234 Apr 13, 2016 5:31 PM Flag

    They already shot it down - it was reviewed in the research plan but not included in the guidelines. Dead.

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