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
69: SAMBA EID and viral load assays submitted to WHO PQ by abbreviated pathway; WHO site inspections completed for both US and UK facilities.
70: Additional automation of production successfully achieved leading to price reduction of all SAMBA assays from $37.40 to $28.80 (22.9% reduction with price including all necessary blood collection materials: gloves, alcohol swabs, lancet etc). Additional price reduction of 15% anticipated by mid 2020.
71: SAMBA II Dash Board to be launched at ICASA 2019 with pilot scale implementations in Kenya, Uganda & Zimbabwe.
72: SAMBA HCV assay development completed. Clinical trials in progress; aim for CE mark by Q2 2020. Continued menu expansion on SAMBA systems with HIV/HCV duplex assay showing high sensitivity/specificity and clinical trial in Q1 2020.
73: Accelerated WHO-PQ applications initiated for 3 SAMBA assays.
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.