We are thrilled to announce the 2024 edition of the NGS DxBook, packed with updated data and expanded insights!
What’s New?
1) Expanded Dataset: We are increasing our lab sample size to 250 (up from 200) to enhance robustness, which now can be analyzed longitudinally vs. 2023 (for the lucky owners of last year’s dataset).
2) New Data: In response to user feedback, we have expanded our dataset to include several key areas. Noteworthy additions (but not limited to!) include cancer monitoring / MRD, how labs are preparing for upcoming regulatory changes (i.e, FDA proposed regulations, IVDR), factors influencing lab decisions (e.g., budget, decision-makers), and a quantitative scoring for various infrastructure adoption criteria.
Here are some findings from Rishikesh and Amal on MRD Testing:
1) Early Adoption Trends: About 35% of institutions in our NGS DxBook are currently conducting MRD tests, primarily using service providers. Adoption rates are similar for solid tumors and heme malignancies, though solid tumor volumes are 3x higher.
2) Reg. Momentum: While FDA approvals for MRD tests are still emerging, significant strides are being made. Notably, Natera is leading the way with its PMA submissions for Signatera in muscle-invasive bladder cancer, and FDA ODAC’s recent vote to recognize MRD as an endpoint for accelerated approval in multiple myeloma may boost heme MRD growth.
3) Reimbursement Landscape: Despite existing challenges, there are positive indicators that insurance providers are beginning to see the cost benefits of MRD testing.
4) Competitive landscape: While public figures / volumes don’t lie, and Natera remains the leader in the space, Natera and Guardant Health are neck and neck in our first surveyed batch!
Feel free to reach out to our team with any questions!
#NGSisUnstoppable
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