2020 HIV DIAGNOSTICS

27. Offering access pricing for technologies that are transparent, consistent, and applicable across assays and donors/procurers and working with donors/procurers to further refine pricing details and transparency.

28. Offer all assays, including HIV, HCV, HBV, HPV and TB on all platforms, including the cobas 4800, 6800, and 8800. (The TB assay is not available on the 4800)

29. Continue to support and strengthen a shared and integrated diagnostic network as well as multi-assay capability on current instrumentation for further optimization and utilization of platform capacity and access to testing.

30. Ensure the plasma separation card is affordable.

Updates

Commitment 30:

April 2021

  • Roche is exploring the use of the cobas® Plasma Separation Card (PSC) as a sample collection device for HCV screening and confirmatory testing. 

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.

36. Consider moving from separate instrument, consumable, and service procurement towards more consolidated, all-inclusive pricing models.

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.

 

72. Prioritize attainment of WHO guidelines for both cobas MTB and cobas MTB-RIF/INH assays

73. Prioritize higher-throughout, multi-disease platforms to enable HIV, MTB and hepatitis testing at larger scale.

74. Offer access pricing and prospective reductions based on global volume thresholds.

Updates

Commitment 72:

April 2021

  • Roche is exploring the use of the cobas® Plasma Separation Card (PSC) as a sample collection device for virological diagnosis of Hepatitis C Virus infection in combination with the cobas® HCV viral load and cobas® HCV genotyping tests.

 

With regards to WHO Prequalification / guidelines :

  • Received WHO Pre-qualification for our cobas® HIV-1 test for use on the cobas® 6800/ 8800 Systems, along with use of the cobas® Plasma Separation Card (PSC)

  • Received WHO Pre-qualification for our cobas® HCV Tests for use on the cobas® 6800/ 8800 Systems

  • Received WHO guidelines for cobas® MTB and cobas® MTB RIF/INH Tests for use on the cobas® 6800/ 8800 Systems


Roche is still pursuing WHO Prequalification of the following tests:

  • cobas® HIV-1/2 qualitative test for use on the cobas® 6800/ 8800 Systems

  • cobas® HIV-1 test on the cobas® 4800 System, including the use of the cobas® Plasma Separation Card (PSC) and the use of DBS for EID 

  • cobas® HPV test for use on the cobas® 4800/ 6800/ 8800 Systems

2018 HIV DIAGNOSTICS

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.

Updates

Commitment 83

June 2021

Roche has expanded the Global Access Program to include the SARS-CoV-2 PCR test.

April 2021

Roche has expanded the Global Access Program to include its tests for Tuberculosis, hepatitis and HPV for cervical cancer screening. All of these tests are currently available and run on cobas 6800 and 8800, which is also used for HIV viral load and EID testing. Submitted its HPV tests for WHO PQ, and they have been accepted for approval via the abridged route.

Commitment 84

Collaboration for better forecasting is ongoing; have had meetings with Global Fund and USAID/Chemonics; we have been advised about the new guidance on shelf life from WHO and are awaiting confirmation on some of the details, once confirmed we will then work with the procurement organizations (Chemonics and PFSCM) to implement. 

Commitment 85

EID indeterminate range - exists already on Cobas system; discussing with WHO on how to implement on newer platforms.

Commitment 86

The pricing breakdown details have now been provided to the Global Fund. 

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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