Guaiac Fecal Occult Blood Test (FOBT) kits

Guaiac kits were developed starting in the late 50s by Dr. Mueller.   A strip of filter pre-coated paper saturated with purified dried Guaiac was smeared with fecal matter and then developed by applying a drop of alcohol/hydrogen peroxide solution on the filter paper to look for blue color in the sample area opposite the sample indicating a hemoglobin reaction.

Once the process was refined by a company and the Guaiac paper put in a cardboard “matchbook”, the gFOBT kit has remained structurally the same now for about 40 years.  Smith Kline widely established the Hemoccult brand widely (now owned by Beckman Coulter).  The primary advances in the last 2 decades have been increased sensitivity, specificity and advanced Positive & Negative Control dot chemistry for the paper kits.

The volumes of kits used in the U.S. by hospitals & clinics are estimated from various sources as ranging from 200-550 million kits per year.  Various estimates of Beckman’s market share of the US FOBT market range from 65%-85% & Beckman sells their kits worldwide.  Well over a dozen brands of paper gFOBT kits are sold in the US market.

ColonTest-Sensitive was required by the FDA to match or exceed the chemistry for the sensitivity and specificity used by Beckman Coulter in their most sensitive gFOBT kits.

Existing cardboard Guaiac FOBT kit design is accepted by FDA regulations, only because they were "Grandfathered" as acceptable since the kits were available before the FDA Device Legislation became law.  No new test kit using volatile and corrosive open bottles of developer fluid that could be misused and become contaminated easily would be allowed to receive FDA clearance today.

Early History of Guaiac FOBT kits

1958 Dr. Mueller impregnated Guaiac resin on filter paper & commercial distribution started:  was a medical advisor to Schieffeiin & Co. in NYC. 

1960s Schieffelin sold Hemoccult to Laboratory Diagnostics Inc. in Roselle, NJ. but LDC did not do the marketing & clinical trials to turn Hemoccult into a mainstream product.

1967 article in JAMA by Dr. David Greegor raised awareness of Hemoccult from his clinical report

1969, SmithKline acquired the rights to the Hemoccult by chance when it bought Clinicult for physicians to culture specimens, and SK started to do better clinically controlled trials of Hemoccult in 1970.

1973 SKD created from SK & French Labs to market Hemoccult heavily.

1979 SKD sales = $6 million on 30 million slides = $.20/slide

Late 1980s Beckman-Coulter buys SKD

1990s Cenogenics/LDI create the highest sensitivity Guaiac FOBT

2002 BC est. sale price per slide by BC ≈ $.35/slide x 120 million/yr est. distributed by Allegiance (Now Cardinal).

Summary data above from page 13+ of file located at

www.fas.org/ota/reports/8123.pdf