Company: ADPT
Filing Date: 2025-03-03
Form Type: 10-K
Source: 0000950170-25-030913
Chunk: 19

Company: Adaptive Biotechnologies Corp
Filing Date: 2025-03-03
Form: 10-K
Item: Item 1
Chunk 19
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 PLA code was published on Medicare’s CLFS with a price of $2,007, effective January 2025. This price represents a 17% increase over our previously determined Medicare rate. Correspondingly, our Medicare episode rate for clonoSEQ was increased from $6,870 to $8,029.

We continue to enhance our average selling price (“ASP”) for clonoSEQ as we are increasing our investments in revenue cycle management to improve claims collection such as prior authorizations and the appeals process. Further, we will continue to sign new contracts with private payors who are not currently contracted with us and improve contracted rates for existing contracted private payors over time.

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We also maintain a patient support program, Adaptive Assist, to facilitate access to clonoSEQ testing services for patients who could benefit from the clinical insights provided by clonoSEQ Clinical Testing. Patients can call to discuss their individual circumstances with one of our dedicated patient support representatives in order to better understand their coverage prior to clonoSEQ testing and to navigate the insurance process, including appeals for denied claims. We also offer financial assistance for qualified uninsured and under-insured patients who cannot afford their patient financial responsibility for clonoSEQ.

MRD Pharma

MRD Pharma focuses on offering our clonoSEQ assay to biopharmaceutical partners to advance drug development efforts. Through 2024, clonoSEQ was being used by over 40 biopharmaceutical companies in more than 170 active clinical trials and is used as a clinical endpoint in over 85 of these studies. Penetration of active industry sponsored clinical trials in lymphoid cancers as of December 31, 2024 varied per indication, with penetration in MM trials being the highest at over 40%.

In April 2024, FDA’s Oncologic Drug Advisory Committee (“ODAC”) voted unanimously in favor of the use of MRD as a primary endpoint to support the accelerated approval of new therapies for patients with MM. ODAC’s recommendation has the potential to accelerate MM patient access to novel therapies and to reduce drug development costs. clonoSEQ is the only FDA-cleared MRD assay for patients with MM, it is also the singular assay that can consistently deliver the sensitivity and standardization needed to meet the FDA’s performance standards. We believe these considerations distinguish clonoSEQ as a leading assay for MM drug developers.

Immune Medicine Business

The goal of our IM business is to scale our target discovery and drug discovery efforts to bring transformative therapies into the clinic either on our own or with a partner. The engine