Translating research into cancer molecular diagnostics and patents

In terms of the Diamond Jubilee celebration of the Journal of Clinical Pathology (JCP), it is evident that molecular pathology is still a relatively young field. Thus, one of the most notable papers published in the journal in this area appeared not 60 years ago, but only 15 years ago. In November 1990, in an article entitled “Monoclonality in B cell lymphoma detected in paraffin wax embedded sections using the polymerase chain reaction”, Alec Morley’s group described the application of the polymerase chain reaction (PCR) to detect B cell monoclonality in formalin fixed, paraffin wax embedded material.¹ This was based on the use of consensus primers for the variable and joining regions of the IGH (immunoglobulin heavy chain) gene, as illustrated in figure 1 of that paper, which has been reproduced here (fig 1). The sensitivity of the approach was documented by positive PCR results in 24 of 26 B cell lymphomas, and its specificity was established by the negative results obtained in 28 other samples. The authors concluded that: “this technique is likely to be of value in routine diagnosis, because of its speed, simplicity, and applicability to fixed, embedded material”. This has proved to be an understatement, because some form of this method has been adopted by almost …