Biohit upbeat on recent tests of ColonView product

Biohit updated the market on its ‘ColonView’ test on Friday, which it described as a new-generation fecal immunochemical test (FIT) designed for the detection of fecal occult blood (FOB) in subjects participating in colorectal cancer (CRC) screening.

The Finnish diagnostic product manufacturer said ColonView-FIT had been compared to a traditional guaiac-based FOB test in a head-to-head study setting, conducted at the Barretos Cancer Hospital (BCH) in Brazil between 2014 and 2018.

It said the results of the study were published in the most recent issue of Anticancer Research in in January 2019, with ColonView-FIT reportedly showing a sensitivity “far superior” to the comparison test in detecting FOB in patients referred for colonoscopy as a part of CRC screening programme.

The new study had a similar design as the ColonView-FIT comparison study conducted in St Petersburg and published in 2015, Biohit said.

It also reported that the results of the two studies were “very similar”, confirming the “superior sensitivity” of ColonView-FIT when compared to the traditional guaiac test - HemoccultSENSA.

It said that interestingly, the difference between the two tests was even more striking in the Barretos study than in the first study.

Between 2014 and 2018, BCH received fecal samples - ideally taken at three consecutive days - from 368 colonoscopy-referral patients, examined by both a ColonView-FIT quick test and the Hemoccult SENSA.

Each subject underwent diagnostic colonoscopy with biopsy confirmation, used as the “gold standard” to calculate the sensitivity and specificity of the two tests for three different endpoints - adenoma, advanced adenoma, and adenocarcinoma.

“For the carcinoma endpoint, the ColonView-FIT test had 94.6% sensitivity and 65.1% specificity, while the HS test had sensitivity of 75.7% and specificity of 84.3%,” said Barretos study principal investigator Professor Kari Syrjänen.

“For the adenoma endpoint, the difference in sensitivity between ColonView-FIT and Hemoccult SENSA was even more pronounced - 44.2% and 19.2%, respectively.

“The authors concluded that the sensitivity of ColonView-FIT for the most reproducible endpoint - invasive cancer - far exceeded the pooled sensitivity estimated in a recent meta-analysis for eight common FIT brands.”

Biohit chief executive officer Semi Korpela added that, on the basis of a recent meta-analysis, ColonView-FIT belonged “among the topmost” new-generation FIT tests on the market, and should be “the natural test-of-choice” for the upcoming CRC screening programme in Finland.

“As one of its most distinct feature, Biohit test detects both hemoglobin and hemoglobin-haptoglobin complex, that makes ColonView-FIT test different from almost all other commercial FIT tests using Hb as the stand-alone marker.

“Adding the Hb/Hp complex in the test increases the sensitivity by 40-50% as compared with Hb alone.”