Yes the study was WITH a bowel prep so it is needed to screen. Big disincentive. Also these patients were symptomatic and high risk, they excluded all IBD patients because it didn't work and 25% of patients had adenomas or cancer. This has very little to do with screening an average risk, asymptomatic population without a colon prep. Not a competitor to CG anytime in the near future.
Aetna updated their CRC screening guidelines 8/7/15 and unfortunately continued to state CG is experimental. Looks like they won't budge until they are forced by the USPSTF. Next update listed in 6/16. Market doesn't seem to mind.
I was just surfing the web at a non medical site and 2 Cologuard ads pop up that are directed to physicians only. Medical lingo and how to sign up. I guess it might not be tough to connect internet dots but I was pretty surprised they knew the ad would be seen by a Dr. I've never seen that before for any other medical device or drug. Cool !
You are right Oldguy - the EXAS story isn't complicated. Patients and docs love the test. The main issue now is commercial coverage and the fact that insurers don't get Quality Measure credit for using CG (per NCQA/HEDIS) and are not required to cover CG. Once USPSTF is A or B, both issues will be resolved. Stock will soar or get crushed with that decision. I think chances of A or B are 90% so I'm in.
What incentive? How about good patient care? It's illegal to get kickbacks for ordering tests. Don't have a very high opinions of Drs., do you? :)
less than 50 years old and the performance of CG. I'm sure someone is looking into it.
New study-Prev Chronic Dis. 2015;12(5)
ABSTRACT: Screening of first-degree relatives of CRC patients is recommended to begin at age 40 or 10 years before the age at diagnosis of the youngest relative diagnosed with CRC. CRC incidence has increased recently among younger Americans while it has declined among older Americans. The objective of this study was to determine whether first-degree relatives of CRC patients are being screened according to recommended guidelines.
CONCLUSIONS: Despite a 5-fold increase in colonoscopy screening rates since 2005, rates among first-degree relatives younger than the conventional screening age have lagged. Screening promotion targeted to this group may halt the recent rising trend of CRC among younger Americans.
Hmmm - 40 yr olds don't want a colonoscopy. Wonder if there is an alternative? :) Would be nice to see data of archived stool specimens on those
Good Aetna find Trader. Interesting that in their policy they approve screening African Americans at age 45 as medically necessary which is NOT a USPSTF recommendation so they obviously are not using USPSTF as there sole source of truth. Makes you wonder if they approve CG will they approve it for AA's at age 45 even though that would be off label?
Jim - it's not the cost of imaging that's the problem it's the lack of specificity. Only 4 out of a hundred suspected lesions turn out to be lung cancer and alot of follow up testing is needed to prove that (besides the radiation exposure to #$%$ on these lesions)
No doctors would not be successfully sued using CG - an FDA, CMS, American Cancer Society, American College of Gastroenterology approved test. Of course any discussion should include informed consent with the other options that are available. Without any other discussion the patient doesn't have informed consent.
After looking over the abstracts, there is some interesting and encouraging stuff but nothing earth shattering or imminent in terms of revenue or medical breakthroughs. I'm thinking this 10% move is due to something else - but not smart enough to know what.
Here's the SDNA FIT abstract
Prevalence of DNA Biomarkers in Fecal Immunochemical Test Positive and
Negative Colorectal Cancers
Theodore R. Levin, Chyke A. Doubeni, Christopher D. Jensen, Wei K. Zhao, Alexis
Zebrowski, Rebecca Oldham-Haltom, William R. Taylor, David A. Ahlquist, Hatim T.
Allawi, Graham P. Lidgard, Douglas A. Corley, Barry M. Berger
BACKGROUND: While fecal immunochemical test (FIT) screening identifies the majority
of patients with asymptomatic colorectal cancer (CRC), the addition of stool DNA biomarkers
to FIT has been shown to significantly improve detection. We sought to determine if
DNA biomarkers in CRC tumor tissue differ between FIT-positive and FIT-negative CRCs.
DNA biomarkers were present in the majority of CRCs, regardless of FIT-positive status.
These findings, if confirmed in stool testing, suggest that CRC screening with novel DNA
biomarkers in combination with fecal hemoglobin may further improve colorectal neoplasia
detection, although the impact on the false positive rate also needs to be evaluated.
identified markers detect EAC and ESCC with comparably high sensitivity, while others
accurately distinguish these subtypes. Given their high discrimination and ease of assay,
such markers merit further exploration for clinical application. .
Most Discriminate Markers on MSP Validation in Independent Tissues
Ssteph -it's long so I'll parts of the abstract:
Novel Epigenetic Markers for Detection of Esophageal Cancer: Selection by
Whole Methylome Sequencing and Tissue Validation
William R. Taylor, John B. Kisiel, Tracy C. Yab, Xiaoming Cao, Patrick Foote, Douglas W.
Mahoney, Navtej Buttar, Thomas C. Smyrk, David A. Ahlquist
Background: DNA methylation studies in esophageal adenocarcinoma (EAC) and squamous
cell carcinoma (ESCC) have primarily focused on known tumor suppressor genes. Such
efforts have yielded important mechanistic insights, but have provided few clinically useful
markers. Massively parallel sequencing technology applied across the methylome affords an
unbiased and comprehensive approach to the identification of discriminant markers for
potential application in cancer screening and diagnosis. Aims: 1) Conduct methylome-wide
discovery to identify EAC and ESCC-specific DNA methylation. 2) Select and validate top
candidate markers suitable for downstream clinical application.
Results: We identified 94 EAC
and 88 ESCC DMRs from over 25 million sequencing reads; 85% had cancer related
ontologies. From these, the top 68 (34 for each subset) were selected for MSP assay and
technical validation. After re-testing, 80% of the candidate markers matched or exceeded
their respective sequencing metrics. Several markers achieved almost perfect discrimination
for EAC. The most discriminant 18 markers were taken to biological validation; 12 achieved
superior AUC, fold change, and control group methylation (Table). Six markers demonstrated
high methylation in both tumor types; the other 6 appeared to target EAC preferentially
over ESCC. One marker in particular, FGF14, highly discriminated EAC from ESCC (Figure)
with an AUC of 0.87. Conclusion: Unbiased methylome-wide sequencing, with appropriate
filtering, yields outstanding candidate markers for detection of esophageal cancer. (next
Agree I'm surprised it's held up so well. After reading the report last night I was expecting a 10%+ drop. Although I think it may drift lower in coming weeks with the normal SVA news vacuum.
The one worthwhile question on the CC was on EV71 and competitors. I believe they said 4 total vaccine makers, one of whom got their inspection notification 2 months prior to SVA but no knowledge of others getting the notification. (I'll have to read the transcript)