2020 HIV DIAGNOSTICS

26. Continue all-inclusive access program across HIV, HBV, HCV, and HPV assays.

Updates

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2020 TB DIAGNOSTICS

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.

 

64. Prioritize the development of a TB assay for the Aptima technology.

65. Incorporate a future TB assay into the all-inclusive, transparent price of $12 across molecular assays.

Updates

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2018 HIV DIAGNOSTICS

74. Enter the EID market through application for CE-IVD mark and WHO prequalification of the dual claim assay with whole blood/dried blood spot.

75. Implement the indeterminate range guidance within the EID product insert in Q1 2019.

76. Maintain the multiplex availability on the Panther system with continued support for the HCV, HBV, and HPV assays.

77. Maintain the all-inclusive, transparent price of $12 across molecular assays (HIV EID and VL, HCV, HBV, HPV assays).

78. Jointly develop and implement KPIs with our partners in country including instrument uptime and mean time to respond/repair.

Updates

October 2020

74 : Hologic has received WHO PQ for the DBS sample type in early August. 

Previous

74. Received CE-IVD certification for dried blood spot for VL and EID. Currently under review by WHO PQ. Hologic got CE/IVD approval with new algorithm and just finishing up final questions with WHO.

75. Implemented indeterminate range for EID product completed.

76. The ability to mulitplex different diseases on their platforms exists already.

77. All inclusive pricing already exists.

78. Have been establishing service level agreements in all countries they are active in with MoHs to establish KPIs, which are fairly consistent across all countries.

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.

Updates

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