Biohit new-generation fecal immunochemical test (ColonView-FIT) is superior to traditional guaiac test in colorectal cancer screening

Biohit Oyj Press release 18.01.2019 at 9.30 local time (EEST)

Biohit ColonView test is a new-generation fecal immunochemical test (FIT) designed for detection of fecal occult blood (FOB) in subjects participating in colorectal cancer (CRC) screening.

ColonView-FIT has been compared with a traditional guaiac-based FOB test in a head-to-head study setting conducted in a leading cancer hospital in Brazil (Barretos Cancer Hospital); BCH) between 2014-2018. The results of this study were published in the latest issue of Anticancer Research, in January 2019 (1), and ColonView-FIT showed a sensitivity far superior to the comparison test in detecting FOB in patients referred for colonoscopy as a part of CRC screening program at BCH.

This new study had a similar design as the ColonView-FIT comparison study conducted in St. Petersburg and published in 2015 (2). Also the results of the two studies are very similar, confirming the superior sensitivity of ColonView-FIT as compared with the traditional guaiac test (HemoccultSENSA). Interestingly, the difference between the two tests was even more striking in the Barretos study (1) than in the first study (2).    

Between 2014-2018, BCH received fecal samples (ideally taken at 3 consecutive days) from 368 colonoscopy-referral patients, examined by i) ColonView-FIT quick test and ii) Hemoccult SENSA (Beckman Coulter, USA). Each subject underwent diagnostic colonoscopy with biopsy confirmation, used as the Gold standard to calculate the sensitivity (SE) and specificity (SP) of the two tests for three different endpoints: adenoma (A), advanced adenoma (AA) and adenocarcinoma (AC).

The principal investigator of the Barretos study, Professor Kari Syrjänen: "For the carcinoma (AC) endpoint, the ColonView-FIT test had 94.6% SE and 65.1% SP, while the HS test had SE of 75.7% and SP of 84.3% (1). For the adenoma (A) endpoint, the difference in sensitivity between ColonView-FIT and Hemoccult SENSA was even more pronounced; 44.2% and 19.2%, respectively (p<0.0001). The authors concluded that the sensitivity (94.6%) of ColonView-FIT for the most reproducible endpoint (invasive cancer) far exceeded the pooled sensitivity (79%) estimated in a recent meta-analysis for 8 common FIT brands (4).”

CEO Semi Korpela, Biohit Oyj: "On the basis of a recent meta-analysis (4), ColonView-FIT belongs among the topmost new-generation FIT tests on the market, and as the domestic (Finnish) innovation (5,6), should be the natural test-of-choice also for the upcoming CRC screening program in Finland. As one of its most distinct feature, Biohit test detects both hemoglobin (Hb) and hemoglobin-haptoglobin complex (Hb/Hp) 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 (2).      

References

1.Guimarães DP, Fregnani JH, Reis RM, Taveira LN, Scapulotempo-Neto C, Matsushita M, Silva SR, Oliveira CZ, Longatto-Filho A, Eklund C,  Paloheimo LI, Mauad E, Syrjänen K. A new-generation fecal immunochemical test compared with guaiac fecal occult blood test for colorectal neoplasia detection in colonoscopy referral patients. Anticancer Res 2019;39:261-269.

2.Vasilyev S, Smirnova E, Popov D, Semenov A, Eklund C, Hendolin P, Paloheimo L, Syrjänen K. A New-generation fecal immunochemical test (FIT) is superior to guaiac-based test in detecting colorectal neoplasia among colonoscopy referral patients. Anticancer Res 2015;35:2873-2880.

3. Pitkäniemi J, Seppä K, Hakama M, Malminiemi O, Palva T, Vuoristo MS, Järvinen H, Paimela H, Pikkarainen P, Anttila A, Elovainio L, Hakulinen T, Karjalainen S, Pylkkänen L, Rautalahti M, Sarkeala T, Vertio H, Malila N. Effectiveness of screening for colorectal cancer with a faecal occult-blood test, in Finland. BMJ Open Gastroenterol. 2015;2(1):e000034. doi: 10.1136/bmjgast-2015-000034.

4. Lee JK, Liles EG, Bent S, Levin TR and Corley DA: Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med 2014;160:171-183.

5. www.biohithealthcare.com/additional-information

6. Immunoassay for fecal human hemoglobin; patent/US4427769: https://urly.fi/18ez

Additional information:

CEO Semi Korpela, Biohit Oyj
tel. +358 9 773 861
investor.relations@biohit.fi

www.biohithealthcare.com

Biohit in brief

Biohit Oyj is a globally operating Finnish biotechnology company. Biohit’s mission is "Innovating for Health” – we produce innovative products and services to promote research and early diagnosis. Biohit is headquartered in Helsinki, Finland, and has subsidiaries in Italy and the UK. Biohit's Series B share (BIOBV) is quoted on Nasdaq Helsinki in the Small cap/Healthcare group.

www.biohithealthcare.com