Precision diagnostics for CML now available through the ATOM Coalition
HIGHLIGHTS
- The ATOM Coalition partner Cepheid has made its first mRNA precision diagnostics for chronic myeloid leukaemia (CML) monitoring available to low- and lower-middle-income countries via the NCD connect procurement platform.
- Designed for fast, automated testing using existing laboratory infrastructure, the tests allow for CML monitoring to help inform clinical decisions, at an access price of around USD 50.
- The availability of CML diagnostics complements expanded access to nilotinib and represents a key step in closing diagnostic gaps, ensuring patients can be treated and monitored over time to optimise disease management.
The diagnostics can be purchased in all ATOM Coalition countries via NCDconnect, an online procurement platform led by Coalition partner IDA Foundation.
Designed for automated, timely testing that can be performed locally using existing laboratory infrastructure and equipment, these diagnostics reduce delays and enable timely and reliable clinical decision-making.
The tests are available at a global access, ex-factory price of approximately USD 50. They are part of a broader portfolio, which also includes tests for HPV and bladder cancer. These will also be made available through NCDconnect.
The availability of CML tests marks an important step in the ATOM Coalition’s efforts to close critical gaps in cancer care in LMICs. Limited diagnostic capacity remains a major barrier to ensuring that cancer medicines are used safely and effectively.
For people living with CML, access to precision diagnostics is essential, not only to confirm diagnosis, but also to monitor treatment response over time.
"Access to medicines without diagnostics leaves patients underserved. Through the efforts of several ATOM Coalition partners, we’re helping countries ensure that people not only have access to quality-assured medicines, but also to the diagnostics and monitoring needed, closer to where people live.”
- Amy Israel, Senior Advisor Access to Medicines, the ATOM Coalition.
The newly available diagnostics directly complement the expanded access to nilotinib, a life-saving treatment for CML. They help ensure that patients who gain access to the medicine can also be effectively monitored, which is an important step for assessing treatment efficacy over time.
While the voluntary licence facilitated through the ATOM Coalition in 2022 has enabled quality-assured generic nilotinib to become available in multiple countries, access to diagnostics is critical to turning this progress into meaningful, long-term patient outcomes.
“At Cepheid, we’re proud to work with the ATOM Coalition and its partners to expand access to molecular tools that support the ongoing management of cancer. By making these monitoring tests available alongside medicines, we’re helping strengthen continuity of care for patients, no matter where they live.”
- Iain Sharp Paul, Vice President, EMEA & APAC Marketing, Cepheid.
Last update
Thursday 30 April 2026
