Company: VCYT
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0001384101-25-000014
Chunk: 9

Company: VERACYTE, INC.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 9
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 Medicare for patients with bladder cancer.

Interstitial Lung Disease - Envisia Genomic Classifier

The Envisia classifier was the first test of its kind for improving the diagnosis of interstitial lung diseases without the need for surgery. We obtained Medicare coverage for the Envisia classifier through the Molecular Diagnostic Services Program, or MolDX program, in 2019. As of December 31, 2024, we have paused offering the Envisia test.

Investing in Innovation to Drive Durable Growth

Expanding Into Minimal Residual Disease

In February 2024, we acquired C2i, an MRD company, or the C2i Acquisition, adding whole-genome MRD capabilities to our novel diagnostics platform and positioning us to serve physicians and their patients further along the care continuum, in combination with our diagnostic and prognostic tests. MRD is a large emerging market, currently estimated at a total addressable market, or TAM, of $20 billion annually. We believe we can leverage our specialist commercial channels while also building relationships with medical oncologists to partner early in a patient’s care, using our indication-specific focus and expertise to drive adoption from the first diagnostic test onward. MRD testing will expand the value we provide to clinicians to inform whether a patient’s intervention was successful or if management escalation is required. 

Our whole-genome, AI-powered approach generates broad signatures from blood more quickly and efficiently than bespoke tumor informed panels. Our MRD solution requires less than a tube of blood (as little as 3-4 ml blood, or 1-2 ml plasma), can go from sample to result in just two weeks, and delivers improved performance compared to imaging and other molecular tests. We believe this ability will enable physicians to track a tumor’s progression as it evolves from early diagnosis through patient treatment and follow-up.

We expect our first application of our MRD technology will be a muscle-invasive bladder cancer, or MIBC, MRD test, where we plan to leverage our strong urology commercial channel and have a clear pathway to expected reimbursement. We also plan to utilize our MRD platform to offer additional MRD tests in several other indications. We have submitted a tech 

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assessment to MolDx, who administers Medicare reimbursement in our lab jurisdiction, and subject to a positive response, expect to launch our first MRD test in the first half of 2026. 

Driving Global Growth with Distributed IVD Tests 

Once we have developed robust clinical evidence and physician adoption of our tests in the