We currently offer two proprietary tests: MammaPrint and BluePrint. MammaPrint is a 70-gene prognostic test that stratifies a specific patient’s recurrence risk and provides a prognostic marker to help inform a patient’s risk along with other clinicopathologic factors. BluePrint is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer tumor and classifies the tumor to provide information about its behavior, long-term prognosis and potential response to systemic therapy. These two tests form a combined platform that is designed to enable accurate classification of personalized breast cancer types, as observed in clinical studies comprising over 30,000 patient samples and reported in over 120 peer-reviewed publications. In pre- and post-operative settings, our platform provides clinically actionable insights that help guide optimal treatment decisions along the continuum of care. To engage breast cancer patients across this journey, we are developing and working to clinically validate a breast cancer-specific liquid biopsy test for minimal residual disease, or MRD, to monitor circulating tumor DNA, or ctDNA, for cancer clearance or recurrence. Our objective with serial liquid biopsy monitoring is to intercept cancer recurrence early and reduce the burden of metastatic disease. We are also developing a Smart Pathology solution to help guide the physician’s treatment decisions for metastatic breast cancer patients. We continue to advance our solutions with innovative analytical modalities such as whole genome arrays, next generation sequencing, or NGS, and digital AI pathology.

Our commitment to advancing diagnostic and laboratory solutions for breast cancer, inclusion in top-tier medical guidelines, and broad coverage and reimbursement, together with our operational and commercial excellence, has accelerated revenue and gross margin to $43.9 million and 73% for the nine months ended September 30, 2021 and $57.9 million and 74% for the year ended December 31, 2020, respectively, resulting in a total comprehensive loss of $24.1 million and $21.3 million, respectively. We believe these are durable business attributes that have enabled us to impact the lives of patients with breast cancer around the world.

Breast cancer is the most common cancer and the leading cause of cancer death in women globally. In 2020, 2.3 million women worldwide were newly diagnosed with breast cancer, while there were 685,000 deaths attributed to the disease. A complex and highly heterogeneous disease, breast cancer encompasses at least 20 known clinical subtypes featuring differential growth profiles and response to therapy. Historically, physicians have used tumor pathology, grade and stage to predict breast cancer recurrence and to guide therapy. Tumor pathology is heavily dependent on the quality of tissue staining, and morphological and protein-based testing often do not fully reflect the true biology of a breast cancer tumor. Physicians may therefore make treatment decisions based on information which does not account for the molecular or functional nature of the patient’s cancer. Unlike many other cancers that are defined by DNA mutations, the functional gene expression profile of breast cancer is fundamental to understanding its cause and etiology, critical growth pathways, differential response to treatments and likelihood of recurrence and metastasis. Clinical decision making based on pathology or imaging alone—and without a complete functional profile of the tumor—may lead to incorrect treatment decisions for patients, resulting in over or under treatment, suboptimal care management, and adverse outcomes. Consequently, we believe there is a critical unmet medical need to functionally profile a woman’s breast cancer throughout the patient journey, including for risk scoring at initial diagnosis, guiding treatment selection in a neoadjuvant (pre-surgical) or adjuvant (post-surgical) setting, longitudinal monitoring post-operatively for disease clearance or early recurrence of metastatic disease. We are developing a suite of proprietary testing solutions that empower physicians to accurately diagnose the disease drivers and predict the progression of a woman’s breast cancer. We estimate the total addressable market for our platform and solutions to exceed $12 billion globally.