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MedTech Outlook | Monday, August 07, 2023
Molecular diagnostics investments are necessary for universal health coverage, cancer care equity, and contextually appropriate technology endorsements.
FREMONT, CA: As national cancer control strategies are being integrated, access to cancer medications in low- and middle-income countries (LMICs) is growing. This improvement can be attributed partly to the WHO's enlargement of the list of essential medicines (EMLs) and the formation of multisectoral alliances that have reduced the cost of cancer medications in developing nations. The inability to effectively adapt current medications is still severely hampered by the restricted availability of cancer diagnoses. There have been further requests to align the EML with the List of Essential In Vitro Diagnostics (EDL) and the List of Priority Medical Devices for Cancer Management (PMDL) to connect investments in cancer diagnostics with those in cancer treatments.
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The few initiatives made to date to advance cancer diagnoses in LMICs have centered on essential pathology services. Molecular diagnostics are still underutilized despite being a standard component of cancer management in high-income nations. Worries about pricing, technological capability, and inadequate diagnostic and clinical infrastructure have mostly brought about this slow adoption. But with the development and use of smaller, more effective point-of-care tools and higher awareness for molecular technologies in the context of the COVID-19 pandemic, the landscape of molecular diagnostics is quickly changing in health care. With the help of molecular diagnostics and experience with the GeneXpert (GX) platform, the world's cancer pathology void can be filled.
The development of molecular diagnostics has helped control infectious diseases worldwide for the past two decades. Novel molecular diagnostics can improve LMIC cancer programs like they do infectious illness control.
On-site CML tests have proven that molecular technology can improve LMIC cancer care. The question is how much. Implementation evaluation, context-appropriate endorsement, and multisectoral investment in relevant technology might leverage molecular diagnostics in global oncology, drawing on infectious disease experiences.
The molecular diagnoses should be extensively validated in-country after clinical confirmation. Stakeholders can utilize the Implementation Outcomes Framework to analyze how contextual factors affect technological effectiveness.
Additionally, the WHO should recommend novel cancer molecular diagnostic tools as diagnostic and implementation studies demonstrate their benefit. Cancer molecular diagnostics may be too expensive for LMIC WHO endorsement. As with Xpert MTB/RIF, endorsements and inclusion in the EDL or PMDL can spur differential pricing programs and multisectoral partnerships that make applicable technology more accessible. The EDL includes immunohistochemistry testing for solid and liquid tumor markers, BCR-ABL transcript, HPV, and epidermal growth factor receptor testing. The EDL and PMDL do not endorse molecular diagnostic technology for these examinations. Xpert HPV and other HPV molecular diagnostics are on the WHO list of prequalified in vitro diagnostics, although none are recommended assays.
LMIC cancer molecular diagnostics will benefit most from multisectoral, continuous funding. Authorized diagnostic technology can be prepurchased in bulk to lower prices and increase access.
Molecular diagnostics are necessary but only affect patient outcomes if matched molecular therapies are inexpensive. Without molecular aberration confirmation, molecularly targeted medicines can be harmful. Thus, therapeutic and molecular diagnostic investments must be made together.
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