24th February 2014 Roche launched the CINtec Plus (p16/Ki67) cervical ICC assay1. This was long awaited after Roche had spent approximately 200 million Euros nearly three years ago for MTM laboratories, the originators of the technology and IP2. The question was; how would this fit within the cervical cancer offering from Roche given their already strong PCR portfolio? Last week’s launch shows it appears to have found elbow room, but how things evolve from here will be interesting. There are proponents of screening by PCR, making PAP redundant but now Roche are offering ICC in this space.

Could CINtec Plus be made redundant by PCR? It will ultimately come down to cost and the question of whether the healthcare economics balance. Both ICC and PCR are considerably more expensive than PAP cytology as a service, however, the added costs of false negatives by PAP may outweigh the overall costs of using more expensive screening assays. The press release refers to 500,000 cases of cervical cancer globally1 with approximate death rates of half of this number. However, these incidence and death rates include countries where no cervical screening occurs. The effect of screening is extremely significant, about 85% of the incidences of cervical cancer and subsequent deaths occur in the less developed world according to the WHO3. In the USA there were approximately 12,000 cases last year, with approximately 4000 deaths associated with cervical cancer4. In the UK the figures are approximately a quarter of the USA’s respectively5. Screening with PAP has been effective in reducing mortality significantly over the last thirty to forty years5. How much further can CINtec Plus and/or PCR reduce these mortality figures and how would the overall cost compare to the current costs? This may well be the tipping point for the success of the Roche assays.

What this does reinforce is that Roche is firmly interested in the diagnosis rather than the prevention. Roche pulled out of vaccine development three years ago when it parted company with Transgene after a 3-4 year partnership6. It was clearly a strategic move. While vaccines are available, the mixed uptake and strategies by governments only to vaccinate females, means there will always be a reservoir of virus in the population generally. Along with the other (comparatively limited) risks of developing cervical cancer the need to screen will remain paramount but in an ever decreasing funding climate can these more expensive approaches replace PAP cytology or will they only ever be a reflex assay for the indeterminate cases? Time and economics will tell.