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.
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
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.
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.
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.
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.
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.