INDIVIDUAL COMMITMENTS - 2018 DIAGNOSTICS

41. Strengthen and expand case-finding through developing nurturing and enabling environments, integrating testing into orphans and vulnerable children (OVC) programs, adapting and localizing case management tools, and promoting social services.

40. Improve case-finding approaches through religious services.

42. Support POC EID as well as case-finding through enhanced testing in inpatient, TB, and nutrition wards through the development of clear policies as well as program and operational guidance, and through implementation support.

43. Promote broader uptake of new sample types for laboratory systems and multiplex testing to improve cost efficiencies.

44. Invest in data management to provide more visibility to optimized laboratory networks for faster corrective actions and better quality testing.

45. Support Country Governments with 1) the latest data on performance and regulatory status of new diagnostics; 2) implementation of global guidance on product approvals and post market surveillance; and 3) once the WHO Collaborative Procedure for IVDs is established, promote rapid adoption, shifting the focus of quality assurance to post-market instead of pre-market.

46. Support the development of programmatic and operational guidance on POC VL for children, adolescents, and pregnant and breastfeeding women including by building evidence to support these policies.

47. Support POC EID as well as case-finding through enhanced testing in inpatient, TB, and nutrition wards.

48. Support broader uptake of new sample types for laboratory systems and multiplex testing to improve cost efficiencies.

49. Support case-finding through contact tracing and testing, including at the community level.

50. Support the near term mapping of diagnostics services in pediatric HIV with a view to optimising their use, alongside TB, HCV and adult HIV services.

51. Mobilize communities to reduce stigma and create demand for point of care diagnostics in order to improve early infant diagnosis.

52. Work with communities, civil society partners, including organizations of people living with HIV and faith partners, to address barriers of stigma and lack of information and increase the uptake of HIV testing among children and families, including advancing family-based testing in West and Central Africa, with linkage to appropriate care and treatment.

Support POC EID as well as case-finding through enhanced testing in inpatient, TB, and nutrition wards.

53. Support POC EID as well as case-finding through enhanced testing in inpatient, TB, and nutrition wards.

54. Promote family HIV testing as a strategy for identifying children with HIV.

55. Provide additional investments and support in West and Central Africa through Bridge to Scale POC diagnostics (including optimizing multiplexing) to close the diagnostic and paediatric ART treatment gaps.

56. Support the expansion of the WHO-led Collaborative Registration Process to diagnostics, and leverage existing projects in diagnostics to support the roll out of the procedure for key diagnostics.

57. Remove duplicative in-country performance evaluations from operational budgets of ongoing investments and grants.

58. Support implementing partners (including CHAI) to address outstanding barriers on diagnostics optimal uptake and scale.

59. Reclassify HIV diagnostic devices from class III PMA to class II 510(k) to expedite patient access to these tests per the July 19, 2018 Blood Products Advisory Committee recommendation.

60. Move to a new pricing model for the Point of Care (POC) m-PIMA molecular diagnostic system for EID and VL assays that is an all inclusive price (including instrument, data services, connectivity, service and maintenance) of $30 per test, moving down to $15 per test with sufficient aggregate EID and VL volumes.

61. To complement existing HIV, viral hepatitis, TB, haemorrhagic fever and other important infectious disease assays, Abbott will to continue to develop additional assays of strategic importance across the platforms.

62. Commit to coordinate across business divisions to provide the most comprehensive solution of centralized and decentralized molecular platforms for each country.

63. Continue to implement consistent and transparent pricing, communicating openly on volume requirements for pricing levels.

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.

69. Submit finger-prick based leuco-depleted HIV viral load and EID assay to WHO PQ.

70. Propose volume-based, bundled pricing for EID and viral load assays and instrument platforms, including service and maintenance costs, in order to reduce cartridge and instrument prices.

71. Launch SAMBA Dash Board for easy data tracking, instrument and assay performance monitoring and stock counts at POC sites.

72. Continue menu expansion of SAMBA I near-POC system and SAMBA II true POC system to include TB, Hepatitis B, Hepatitis C, HPV etc.

73. Work with WHO re consideration and implementation of indeterminate range for SAMBA assays

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.

79. Complete the actions necessary to expand the product claim originally submitted to and listed by WHO PQ for the use of the professional use product to allow caregivers to test children 24 months and older by end Q1 2019.

80. Develop and execute a study by end Q2 2019 to verify usability in adult caregivers testing children with OraQuick HIV Self-Test.

81. Work with partners to develop and execute a more comprehensive study to assess social consequences of the use of the OraQuick HIV Self-test in testing children by parents or caregivers for consideration by WHO in self-testing guidelines

82. Support development of optimized laboratory networks and introduction of new, innovative solutions to the marketplace.

83. Develop additional assays for current laboratory technologies, including TB, hepatitis, and HPV to support multiplex testing.

84. Closer collaboration with countries, partners, and donors for better forecasting.

85. Include the EID indeterminate range into new systems.

86. Provide pricing transparency through Global Fund collaboration.

87. Support development of key performance indicators.