Exact Sciences Corp.

Company Overview

Exact Sciences Corp. founded in 1995, develops and markets cancer screening and diagnostic assays globally. Key assays include Cologuard (colorectal cancer), Oncotype DX (breast, prostate and colorectal cancers) and Oncotype DX AR-V7 Nucleus Detect (prostate cancer). Exact Sciences has two of the strongest brands in cancer diagnostics: Cologuard and Oncotype.

Cologuard is a noninvasive stool-based DNA screening test to detect colorectal cancer and precancer. Oncotype DX is a gene expression test for breast, prostate and colon cancers. Oncotype DX AR-V7 Nucleus Detect is a liquid-based test for advanced stage prostate cancer.

Exact Sciences is working on the development of additional tests for other types of cancer, with the goal of becoming a leader in cancer screening and diagnostics.

In November 2019, Exact Sciences acquired Genomic Health. Genomic Health Inc., founded in 2000, develops and markets genetic diagnostic tests for cancer; these are intended for physicians to make treatment decisions using patients’ individual genetic profiles.

Genomic Health’s first commercial product, Oncotype Dx, was launched in 2004 for patients with early-stage, node negative (N-), estrogen receptor positive (ER+) breast cancer who will be treated with tamoxifen.

The test uses RT-PCR to provide information about how likely a patient’s cancer will recur, the likelihood the patient will survive for 10 years following treatment and if the patient will benefit from chemotherapy.

Genomic Health launched Oncotype Dx tests for colon cancer (2010) and prostate cancer (2013). The company is also developing molecular diagnostics for renal cell carcinoma, NSCLC, ductal carcinoma, and melanoma.

In March 2020, Exact Sciences acquired Paradigm Diagnostics and Viomics. Paradigm provides a therapy selection test for late-stage cancer patients. Viomics provides critical sequencing and biomarker discovery capabilities. These two acquisitions strengthened Exact Sciences’ position in the advanced cancer diagnostics industry.

Paradigm Diagnostics’ lead product is PCDx (Paradigm Cancer Diagnostic).

The PCDx test is an NGS-based cancer test that provides information about the genomic and proteomic nature of a patient’s cancer, and gives guidance on the best course of treatment. The test analyzes cancer-related variants in more than 40 genes and copy number variants in 26 genes. It also measures mRNA expression of 50 genes and uses IHC to measure protein expression of 20 genes. This test runs on the Illumina NextSeq platform.

PCDx testing is certified under the CLIA, and Paradigm has achieved accreditation by the College of American Pathologists. In prospective clinical studies, PCDx has helped guide treatment decisions and been clinically proven to significantly increase progression-free survival.

In October 2020, Exact Sciences entered into a definitive agreement to acquire Thrive Earlier Detection, a developer of pan-cancer liquid biopsy tests.

In October 2020, Exact Sciences acquired Base Genomics, a DNA methylation analysis company.

With these acquisitions, Exact Sciences is positioned to make pan-cancer blood screening a part of standard medical care, boosting the market for these tests. Thrive’s CancerSEEK test is a multi-cancer detection assay supported by large-scale clinical data. This test is different from other early detection assays because it is designed to be combined with a full body PET-CT scan for a complete diagnosis.

In October 2020, Exact Sciences extended its previous relationship with Pfizer to promote the Cologuard test. Pfizer agreed to continue to provide marketing and related support for Cologuard and join Exact Sciences’ efforts to educate patients, physicians and health systems about Cologuard.

Financial Highlights (FY 2023)

Company's Business Segments

• Screening : This segment includes the Cologuard test, a noninvasive, stool-based DNA (cDNA) screening test, and Clinical Genetic testing, which provides more than 5,000 predefined genetic tests for all genes, additional custom panels, and comprehensive germline, whole exome (PGxome ), and whole genome (PGnome) sequencing tests.
• Precision Oncology : This portfolio provides better genomic insights to inform prognosis and cancer treatment after a diagnosis. This test includes the Oncotype DX Breast Recurrence Score, Oncotype DX Breast DCIS Score, and OncoExTra tests.
• COVID-19 Testing