History & Major Events

The Rise of White-Label and Generic Test Strips

The diabetic test strip market has shifted from a high-margin monopoly to a price-competitive landscape driven by the Medicare Competitive Bidding Program, which slashed reimbursement rates by over 70% in 2013. This economic pressure fueled the rise of two distinct non-branded categories:

1. White-Label (Store Brands): Authorized products manufactured by companies like Trividia Health and AgaMatrix for retailers (CVS, Walgreens), offering FDA-cleared reliability at lower costs.

2. Third-Party Compatibles: Generic strips (e.g., GenUltimate, UniStrip) reverse-engineered to function in popular branded meters (like OneTouch), bypassing the "razor-and-blades" lock-in.

While ISO 15197:2013 standards eliminated low-quality generics by enforcing stricter accuracy, major OEMs continue to combat this trend through patent litigation and technological lock-outs (proprietary coding and impedance checks) to prevent third-party strips from functioning in newer meter generations.

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[Diabetic Test Strips](/sell-diabetic-supplies): A New Era

The diabetic test strip market is changing fast. Medicare's Competitive Bidding Program sparked this shift in 2013, slashing reimbursement rates by over 70% [1].

What's Driving the Change?

Two new players have emerged:

  • White-Label Brands: Companies like Trividia Health and AgaMatrix make reliable, FDA-cleared products for retailers like CVS and Walgreens.
  • Generic Strips: Brands like GenUltimate and UniStrip offer affordable alternatives that work with popular meters like OneTouch.

Quality Matters

The ISO 15197:2013 standards ensure generics meet strict accuracy requirements [2]. But major manufacturers fight back with patent litigation and technological lock-outs.

The Future

The rise of white-label and generic test strips has transformed the market. It's now more competitive and price-driven. As technology evolves, manufacturers must adapt to stay ahead.

References

  1. Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and SuppliesSource
  2. FDA Guidance: Blood Glucose Monitoring Test Systems for Prescription Point-of-Care UseSource

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