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.

54. Continue development of a blood-based assay for TB.

55. Continue the work on the stool sample validation with FIND for MTB/RIF assay with an estimated launch in 2021.

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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:

Surcharge price for service and maintenance - have signed agreements with 5 countries and in discussion with 3 others

Commitment 65:

Responded to PEPFAR RFP which has the potential to shape the market with a price-volume scale included in the document.

Commitment 66:

GenExpert EDGE prequalified in March through a change request approval and HCV whole blood finger-prick assay is now under PQ review

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 22:

Strong commitment to stay in the EID market.

Commitment 23:

Pricing are published and consistent across LMICs.

Commitment 25:

SLAs signed as part of Cepheid AccessCare.

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.

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.

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.

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.

34. Ensure diagnostic studies include children and alternative (non-sputum-based) sample types.

35. Expedite development of point-of-care biomarker-based tests for infants and children.

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.

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.

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