HIV TREATMENT
2020
Action 27. Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 34. Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.
Paediatric HIV & TB : Rome Action Plan
53. Support further decentralization of testing through release of the GeneXpert Omni technology in 2021 in a limited set of countries; broader market release in 2022.
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54. Continue development of a blood-based assay for TB.
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55. Continue the work on the stool sample validation with FIND for MTB/RIF assay with an estimated launch in 2021.
Commitment 53:
June 2022
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WHO has issued an updated guidance on management of TB in children and adolescents in April. It includes the use of stool as a sample type.
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October 2021
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After many years of investment in the GeneXpert Omni platform, Cepheid made the decision that this was not a sustainable technology and decided to stop the development. This is the reality for both Cepheid's HBDC and commercial markets. This has to be seen also in light of commitment 66, as Cepheid will use the GeneXpert EDGE platform to respond to the need for further decentralization. Xpert HIV Qual (EID) is already on EDGE (as is Xpert MTB/RIF Ultra) and Cepheid is in the process of validating HIV VL.
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Commitment 54:
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October 2021
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The development is actively continuing. There will be a Cepheid symposium during the upcoming Union meeting on 19th October 18:15-19:45pm CET
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Commitment 55:
June 2022
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WHO has issued an updated guidance on management of TB in children and adolescents in April. It includes the use of stool as a sample type.
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October 2021
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KNCV has published on stool sample process to be used on Xpert MTB cartridges.
64. Include a small additional surcharge price (ideally with a maximum of $1.50, but volume dependent) to cover the service level agreement in 2019.
65. Evaluate the potential for further price reductions with increased volumes of all virology molecular assays (HIV, HCV, HBV, HPV) in 2019.
66. Support further decentralization through launch of EDGE technology and HCV testing through finger-prick assay development and submission to regulatory bodies and WHO PQ in 2019.
67. Work with WHO on the potential inclusion of a clinical indeterminate range for the EID assay in 2019.
68. Improve comprehensive connectivity solution.
Commitment 64
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October 2021
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There are 9 countries under the AccessCare program, and discussions with several more are under way.
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Commitment 65
October 2021
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Our virology assay price $14.90.
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October 2020
Commitment 64: Cepheid has 6 countries with agreements fully signed and up and running; 2 countries in the signature phase (signed by one party); 3 countries in advanced negotiation stages.
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Previous
Commitment 64:
Surcharge price for service and maintenance - have signed agreements with 5 countries and in discussion with 3 others
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Commitment 65:
Responded to PEPFAR RFP which has the potential to shape the market with a price-volume scale included in the document.
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Commitment 66:
GenExpert EDGE prequalified in March through a change request approval and HCV whole blood finger-prick assay is now under PQ review
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22. Make every effort to stay in the EID market to ensure there is a sufficient testing capacity to reach and maintain accelerated Fast Track targets (95% of HEI tested by 2020 and beyond).
23. Ensure consistent reagent pricing across partners within countries and within regions, and provide a transparent breakdown of pricing for the products and services sold.
24. Consider moving from separate instrument, consumable, and service procurement towards more consolidated, ideally all-inclusive pricing models.
25. Provide service level agreements that clearly spell out key performance indicators POC, near POC, and high-throughput laboratory instruments, including target up-times and failure rate threshold (with consideration for different causes), plus a mitigation plan when the threshold is exceeded.
26. Consider the inclusion of a clinical indeterminate range in test result reports for more accurate diagnosis of infants per WHO guidelines.
27. Rapidly communicate stock shortages with major buyers and work on joint mitigation strategies.
Commitment 24
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October 2021
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Cepehid has launched an all-inclusive approach for its GX XVI instrument @ $14.90, with a 3-year commitment of 10k virology cartridges per year per instrument
Commitment 25 :
October 2020
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Cepheid has developed a standard SLA template with the IDC that countries can readily use.
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Previous
Commitment 22:
Strong commitment to stay in the EID market.
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Commitment 23:
Pricing are published and consistent across LMICs.
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Commitment 25:
SLAs signed as part of Cepheid AccessCare.
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24. Launch an all-inclusive ceiling price (including instrument, cartridges, service and maintenance, etc) of $14.90 for virology tests, including HIV, HBV, HCV, and HPV, in January 2021.
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25. Reduce the price per test for HIV, HBV, HCV, HPV molecular tests in 2021 for those countries unable or not yet ready to access the all-inclusive program.
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32. Prioritize the pediatric TB diagnostic space to ensure there are improved tools for pediatric TB infection and disease detection to reach and maintain targets.
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33. Develop quality-assured, affordable, less invasive alternative specimen processing methods or products (not based only on sputum) that can be used for the pediatric population, such as urine, stool or saliva.
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34. Ensure diagnostic studies include children and alternative (non-sputum-based) sample types.
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35. Expedite development of point-of-care biomarker-based tests for infants and children.
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36. Consider moving from separate instrument, consumable, and service procurement towards more consolidated, all-inclusive pricing models, for both laboratory-based and point-of-care technologies.
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37. Provide service level agreements that clearly spell out key performance indicators for all technology types and their offered service plans, plus a mitigation plan when the threshold is exceeded.
October 2021
Commitment 24
Cepehid has launched an all-inclusive approach for its GX XVI instrument @ $14.90, with a 3-year commitment of 10k virology cartridges per year per instrument