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Amarin Corporation plc Message Board

marsala1234 10 posts  |  Last Activity: 16 hours ago Member since: Jan 31, 2003
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  • Abstract and Introduction
    P G Vaughan-Shaw, M Aung, K Sahnan, P Rai, A Goodman
    Disclosures
    Frontline Gastroenterol. 2014;5(4):249-253.

    Abstract

    Objective An important marker of colonoscopy quality is detection of pathology and incidence of missed pathology. Back-to-back colonoscopies cannot ethically be performed for quality assurance alone yet may be required for clinical reasons. This study aims to investigate the incidence of new findings in colonoscopies repeated within a 12 month period and considers the role of such an analysis in the assessment of colonoscopy quality.

    Design All colonoscopies performed over a 3-year period at an endoscopy training unit were studied. Colonoscopies repeated within a 12-month period were analysed.

    Results 5747 colonoscopies were performed over the study period. 137 repeat colonoscopies were included with median interval from initial colonoscopy of 174 days. 19 (14%) repeat colonoscopies yielded new findings including one cancer, 234 days following a normal colonoscopy. Additional polyps were identified in 13 colonoscopies indicating a missed polyp rate of 9%. In these, a median number of two polyps per colonoscopy with median size 5.5 mm were found. There was no morbidity associated with repeat colonoscopy in this series. New findings on repeat colonoscopy appeared more likely following initial colonoscopy by non-consultant non-training grade endoscopists (23% vs 11%, p=0.09) yet small numbers involved preclude meaningful comparison.

    Conclusions Analysis of clinically indicated repeat colonoscopies and rate of detection of new pathology may offer utility in colonoscopy quality assurance and would offer a direct assessment of the most important aspect of colonoscopy quality.

    Funny- 14% is about the false +'s of Cologuard!

  • Reply to

    "Homie don't do dat"

    by u_fail_again Sep 3, 2014 2:33 PM
    marsala1234 marsala1234 Sep 3, 2014 4:49 PM Flag

    Scorekeeper - I think you meant to say there were only 8 African Americans with a diagnosis of Colon Cancer.
    There were 1,000 AA's enrolled in the study or 10.7% of the Deep C patients.

  • I'm going to give an honest opinion that some in the crowd may disagree with! This comes after extensive discussion with alot of docs and my own analysis.
    I'll start with a few assumptions:
    -Physician acceptance of CG will be a big driver in it's success
    -Physicians are becoming more cost conscious of the things they do than they were in the past (cost effectiveness is a bigger part of the education process)
    -Some physicians will see a cost of $500-$600 every 3 years as excessive compared to FIT (without understanding the big advantages of CG over FIT as they won't understand the nuances that some on this board do). Perception is reality for some.

    Therefore, I am actually thinking that the "sweet spot" of great margins combined with physician acceptance and use might be in the $350-$450 range. (averages out to around $133/year with q 3 year use).
    I am actually hoping for this range as an investor and a doc as giving the best long term returns.

    Long timers - What do you think? Crazy wish?

  • Reply to

    Affordable Care Act will be our friend in 2015

    by ranjovance Oct 14, 2014 8:53 PM
    marsala1234 marsala1234 Oct 14, 2014 11:59 PM Flag

    Ranjo - where did you get information that the USPSTF review of CRC will be in early/mid 2015? I thought KC said it would be end of 2015? Thanks

  • marsala1234 marsala1234 Sep 6, 2014 5:02 PM Flag

    Ssteph - You are correct there is no screening recommendations for average risk patients. High risk patients can be screened by:
    Endoscopic ultrasound (EUS), a minimally invasive imaging test that uses an endoscope (thin, flexible tube) to evaluate the pancreas for lesions or early cancers. If suspicious lesions are present, doctors obtain tissue biopsies during the same procedure.
    Magnetic resonance cholangiopancreatography (MRCP), a type of magnetic resonance imaging (MRI) test that focuses on the pancreas and bile duct.
    Computed tomography (CT) scans, another imaging test that can show some types of suspicious lesions. Here, our experts can offer high-resolution 3-D pancreatic CT imaging, which produces better, more detailed diagnostic images.
    Endoscopic retrograde cholangiopancreatography (ERCP), a test that combines the use of endoscopes and X-rays to visualize the pancreas and biliary tree. Biopsies can also be performed during ERCP.

    I would guess you would have to examine stool of patients with various stages of Pan-c and determine the proper markers and cutoffs like they did with Cologuard. (This is already happening). You might get approval to sell this to high risk patients while a prospective randomized control study of high risk patients without known Pan -c is in progress. This type of study would likely take several years since Pan-c is much less common than colon ca. I imagine one or a combination of the above screening tools would be used to try and catch the cancer as early as possible.

  • marsala1234 marsala1234 Sep 26, 2014 1:25 PM Flag

    I heard the Osgood file on the way into work today. It was basically a redo of the AOL video spot with the same 2 doctors talking. What amazed me was that Charles sounded like a walking advertisement for Exact. It was almost like he was being paid to run the spot. (that couldn't possibly happen :) )

  • Reply to

    AMAZING conference call… EXAS is a winner!

    by sleepyeye55 Oct 27, 2014 10:55 AM
    marsala1234 marsala1234 Oct 27, 2014 2:41 PM Flag

    Yeah lots of good stuff Ranjo. I was surprised by the # of orders already. 1000 between fda approval and CMS decision and 1150 since. I know orders don't necessarily = revenue but that would be $1 million in orders already and they are accelerating - very nice.

  • Reply to

    Medscape article

    by marsala1234 16 hours ago
    marsala1234 marsala1234 16 hours ago Flag

    He was hopeful that the new test "will stimulate discussions between patients and their healthcare providers. Colonoscopy is still the preferred strategy, but for anything that raises the awareness of screening and acceptability of screening, I am all in."

  • Reply to

    Medscape article

    by marsala1234 16 hours ago
    marsala1234 marsala1234 16 hours ago Flag

    The new test was welcomed by experts when it was approved, even though they warned that it would be more expensive than traditional stool tests.

    The new test does more: "We are looking for DNA changes, methylation changes, and fecal blood, all in one test," commented John Marshall, MD, professor of medicine and director of clinical research at the Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, in his Medscape Oncology videoblog.

    It performed better than FIT in terms of detection, but it was slightly less accurate, he noted. "This means that we will see a few more false positives with this test, but nonetheless, it is a useful test."

    "I believe the role ― the niche ― for this technology will be in that group of patients who refuse colonoscopy or cannot have colonoscopy. There probably will be some crossover with colonoscopy, and this test will be used along with that. Regardless, whatever it takes to get people to undergo screening to keep them out of my office is valuable," he said.

    "It is a test that should be offered to patients who refuse colonoscopy," agreed another expert, David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, in Norfolk, in a Medscape Gasteroenterology videoblog. He also warned that the test will be expensive, but argued that "it is money well spent if it brings the people who refuse colonoscopy into a screening program." He added, however, that "cost analysis and cost-effectiveness remain to be defined."

    But Dr Johnson was adamant that "no screening is not an option. Any screening is better than nothing. We have a screening gap of approximately 20%; we are going to need to increase screening rates from 60% to 80% by 2018."

    (cont)

  • High Price Tag for Cologuard Confirmed, but Test Is Welcomed

    Zosia Chustecka
    November 26, 2014

    A final price decision has been announced for Cologuard (Exact Sciences), the first stool DNA colorectal cancer (CRC) screening test, which was approved in the United States earlier this year.

    The Centers for Medicare & Medicaid Services (CMS) has issued its final payment decision regarding Cologuard and will reimburse it at $502 per test, the company announced.

    The final payment decision follows a comprehensive evaluation by the agency as part of a joint FDA and CMS parallel review pilot program, the company said, and noted that Cologuard is the first technology to gain approval through this program.

    The price is hugely more than that of traditional stool tests for CRC screening, which home in on hemaglobin in blood in the stool samples. There are various such tests available, with the simpler fecal occult blood test (FOBT) costing around $4 per test and the more sophisticated fecal immunochemical test (FIT) costing around $8 per test, according to a 2012 article. The same article gives an average cost for colonoscopy, which is considered to be the best method for CRC screening, at $ 6345 per procedure.

    Improvement on Traditional Tests?

    When it was approved, the FDA pointed out that Cologuard detected more cancers than the commonly used FIT.

    The clinical data come from a pivotal trial that compared the two tests in nearly 10,000 individuals (N Engl J Med. 2014;370:1287-1297. Abstract). Cologuard detected 92% of colorectal cancers and 42% of advanced adenomas; by contrast, FIT screening detected 74% of cancers and 24% of advanced adenomas.

    However, Cologuard was less accurate than FIT at identifying patients who tested negative for colorectal cancer or advanced adenomas, giving a negative screening result for 87% of the cohort vs 95% for FIT.

    (cont)

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