How does the program work?

The aim of the iCMLf Diagnosis & Testing Program is to build local capacity for CML diagnostics. In this way we can improve patient outcomes. Diagnosis & Testing grants are available to physicians, scientists and hematology laboratory staff working in a hospital or research institution. Building local capacity and resource sustainability are important criteria for this iCMLf funding.

The emphasis will be on finding partners in emerging regions who can implement a local solution and leverage local support on top of the limited iCMLf funds. The iCMLf will provide seeding grants to assist in funding tests, reagents, sample transport and the logistics to conduct the program.

To ensure successful implementation of the projects there is a need to establish strong links between local centres and CML centres of excellence. This will provide the technical and clinical support necessary for result interpretation and clinical follow up longterm.



To facilitate this, the iCMLf will offer a limited number of grants to hematology centres in Emerging Regions. These grants will be awarded on evaluation of submitted proposals that clearly demonstrate how the funded activity will improve access to CML diagnosis and testing. The grants will provide funding of up to a maximum of US $20,000 per grant along with additional support from a partnering CML centre of excellence. This model, with the iCMLf as facilitator of locally driven enterprises, rather than as a controller of the program will allow the local sites the flexibility to run the program according to their local situation with the support of a CML centre of excellence.

What is the need for diagnostic testing?

It could be argued that the diagnosis of CML can be made with a moderate level of confidence by clinical and morphological studies alone without the need to BCR-ABL mRNA testing or detection of the Philadelphia (Ph) chromosome in marrow metaphases. However this assumes a level of experience and training that will not always be available. Detection of BCR-ABL or the Ph chromosome provides a definite diagnosis in the right clinical context. Many hospitals and clinics in developing countries do not have the capability to confirm the diagnosis of CML either by cytogenetics or by molecular tests, which results in patients not being able to access the medication available to enhance and extend their quality of life. To increase access to these tests for patients in emerging regions the iCMLf aims to set up facilities at a local level to either bring high quality testing to the patient, or to develop a low cost strategy for sending patient samples to a central laboratory for testing.



What is the need for monitoring?

Many patients who are able to access imatinib through the Glivec International Patient Assistance Program (GIPAP), or other national programs do not have access to regular molecular or cytogenetic monitoring. This means that the first sign of poor drug adherence, drug resistance or disease progression is often frank hematological relapse or blast crisis. Salvage therapy in these settings is often ineffective so that the opportunity to intervene at an early stage when a switch in therapy or an allogeneic transplant may have been effective is lost. Reliable, sensitive monitoring is important to evaluate the effect of treatment, provided that the tests are performed on a regular basis. It is also critical that the treating physician is able to interpret the result appropriately. It may not be realistic to aim for ongoing 3-6 monthly testing in all patients so our initial focus will be on achieving early molecular screening 6 and 12 months after therapy begins. We know that patients who are not below 10% BCR-ABL (IS) by these time points have a high risk of progression. Identifying these patients within the first year may provide the opportunity for an effective intervention such as an increased dose of imatinib, a switch to another TKI or consideration for allogeneic transplant.

Further information and the application form can be downloaded here:

• iCMLf Diagnosis and Testing Program 2018 information
• iCMLf Diagnosis and Testing Program 2018 application form
• WHO list of countries considered as emerging economic countries for this iCMLf program