MedAccess volume guarantee for SD Biosensor Standard G6PD Test

Related program: Diagnostics

Frequently Asked Questions

What is a volume guarantee?

The volume guarantee ensures that an agreed-upon volume of tests is procured from SD Biosensor each year, regardless of market conditions. This helps SD Biosensor to stabilize production planning and operations around their STANDARD(TM) G6PD tests while also maintaining the supply of a regulatory approved quantitative point-of-care G6PD test for use in ongoing pilots and implementation programs.

Does this volume guarantee change how we use and/or procure G6PD tests?

No. The procurement process for SD Biosensor’s G6PD tests will not change. If you are currently procuring tests from a local distributor, you will continue to do so.

Is the volume guarantee an endorsement that SD Biosensor's STANDARD G6PD tests are considered the industry standard?

No. The volume guarantee is not an endorsement. However, MedAccess and PATH are confident in the quality and the value of SD Biosensor’s STANDARD G6PD tests. Many malaria programs are making significant efforts to increase the adoption of G6PD testing, and this volume guarantee will ensure continued availability.

What does this volume guarantee mean for the other G6PD products?

The SD Biosensor G6PD test is a regulatory approved, quantitative point-of-care test with specific use cases. Other types of G6PD tests already on the market, or available soon, will not be impacted by this volume guarantee. Users should continue to make informed decisions around which tests are most appropriate for their specific needs.

Will this volume guarantee make it difficult for my company to launch our G6PD product into the market?

MedAccess will provide a four-year volume guarantee to SD Biosensor, to secure supply of their G6PD test. There are currently no other regulatory approved quantitative POC G6PD tests on the market. It is anticipated that a volume guarantee will assist companies presently developing a quantitative POC G6PD test by ensuring that the market continues to exist and grow.

Is this volume guarantee going to affect the price of G6PD tests?

While a price reduction was negotiated between SD Biosensor and MedAccess, user pricing will not be solely determined by the prices offered by SD Biosensor. End user pricing will differ based on shipping costs, import and distribution regulations, global economic circumstances, and other influences. Please contact your local distributor for the most up-to-date information on test pricing.

What was PATH's role in the volume guarantee?

PATH supported MedAccess and SD Biosensor in collecting market intelligence and advising on the structure of the volume guarantee deal to ensure impact, fairness, and sustainability for the overall market.

How will PATH support this guarantee?

During the volume guarantee period, PATH will support MedAccess and SD Biosensor in monitoring demand to support the deal's implementation. However, PATH will also continue to support various product developers in advancing high-quality G6PD tests to ensure a healthy market.