ADDED
"Veracyte," "Afirma," "Percepta," "Envisia," "Prosigna," "Lymphmark," "Decipher," "GRID," "C2i", "C2i Genomics" and the Veracyte logo are registered trademarks, and "TrueMRD" is a pending trademark application, of Veracyte, Inc.
Our international distribution of IVDs is currently focused on our Prosigna test and, in the future, we intend to offer Decipher Prostate as an IVD.
In the near-term, we are focused on continuing to expand Decipher Prostate's penetration and leadership position while also sustaining strong growth for Afirma.
In particular, we are prioritizing the following growth drivers: the launch of TrueMRD, our minimal residual disease, or MRD, platform to expand our reach further across the cancer care continuum and the launch of Prosigna as an LDT for the U.S.
market to be able to serve more patients in the United States who face a breast cancer diagnosis.
In addition, we are focused on longer term growth drivers like the launch of IVD products for patients globally, and solving new cancer challenges, with tests such as our novel Percepta Nasal Swab test for patients identified with a lung nodule.
We currently take a whole-transcriptome approach to our diagnostic, prognostic and predictive tests and with our MRD technology will add a whole-genome approach for treatment effectiveness, monitoring, and disease recurrence detection.
The Decipher Prostate test uses whole-transcriptome analysis and machine learning to assess tumor biology and estimate the risk of developing metastatic disease in localized prostate cancer and the risk of metastatic progression in patients with metastatic disease, helping guide treatment planning.
Decipher Prostate is performed on prostate tissue obtained from biopsy or surgical specimens and is used to inform clinical decision-making across the spectrum of prostate cancer, including active surveillance decisions; selection among active surveillance, focal therapy, and definitive treatment; use of androgen deprivation therapy (ADT) with primary radiation therapy, including ADT duration; and the timing and intensity of treatment following radical prostatectomy, including treatment intensification with androgen receptor pathway inhibitors (ARPIs) or chemotherapy.
To our knowledge, Decipher Prostate is the only genomic test used across the full continuum of prostate cancer, supported by evidence from more than 115 peer-reviewed, published studies.
REMOVED
When used in this report, all references to "Veracyte," the "company," "we," "our" and "us" refer to Veracyte, Inc., together with its consolidated subsidiaries, unless otherwise noted.
Immunoscore is the registered trademark of Institut National de la Sant et de la Recherche M dicale, or Inserm, in the United States and selected countries and used by Veracyte under license.
Additionally, our Percepta Nasal Swab test is currently being run in our CLIA labs in support of clinical studies.
Our international distribution of IVDs is currently limited to our Prosigna test, however, in the future, we intend to offer Decipher Prostate and Percepta Nasal Swab as IVDs.
In the near-term, we are focused on continuing to expand Decipher Prostate's market size, penetration, and leadership position while also sustaining strong growth for Afirma.
In particular, we are prioritizing the following three growth drivers: first to serve more of the patient journey through our expansion into minimal residual disease, or MRD, testing; second, to launch IVD products for patients globally; and, third, solve new cancer challenges, such as with our novel Percepta Nasal Swab test for patients identified with a lung nodule.
While we currently take a whole-transcriptome approach to our diagnostic, prognostic and predictive tests, we believe our MRD technology will add a whole-genome approach for treatment effectiveness, monitoring, and disease recurrence detection.
Many of these patients receive indeterminate results (i.e., not clearly benign or malignant) based on traditional cytopathology evaluation.
Historically, most of these patients were referred to diagnostic surgery, even though 70% to 80% of the time, the nodules proved to be benign.
The test was developed with whole-transcriptome RNA sequencing and machine learning to provide physicians with clinically actionable results from the same FNA biopsy used for initial cytopathology.