Home 5 Lab Industry Advisor 5 Laboratory Industry Report 5 Deals-lir 5 Dx Deals: Exact Sciences Makes Big Moves to Maintain Leadership of Cancer DNA Testing Market

Dx Deals: Exact Sciences Makes Big Moves to Maintain Leadership of Cancer DNA Testing Market

by | Aug 1, 2023 | Deals-lir, Essential, Laboratory Industry Report

Release of second-generation Cologuard test data and recently announced partnerships aim to position company well for the future.

This was a good month to be an Exact Sciences shareholder. Already a Wall Street darling, the genetic cancer screening innovator further buoyed investors by not only releasing data showing the strong performance of its second-generation Cologuard test, but also entering into a pair of strategic research collaborations to bolster its future position in two other key segments of the cancer testing market.

The Potential of Cologuard 2.0

Though it offers a full portfolio of DNA tests for early cancer screening, Exact Sciences’ flagship is Cologuard. Cleared by the FDA in August 2014, the noninvasive, stool-based test is recommended by clinical testing guidelines and covered by Medicare and most other major payers in the US.1 Last month, Exact Sciences announced new study data suggesting that the next generation of Cologuard may be even more effective than the highly respected original, with a lower risk of false positives.2

The data come from BLUE-C, a multicenter clinical trial whose more than 20,000 participants make it one of the largest clinical trials ever performed to assess a colorectal cancer screening test. Study participants, all adults over age 40, received either the updated Cologuard test or a fecal immunity test (FIT) that detects blood in stool. After comparing the results to participants’ colonoscopies, the researchers found that the new Cologuard test had a specificity of 91 percent and sensitivities of 94 percent for cancer and 75 percent for high-grade dysplasia. These results compare favorably to those of the 2014 DeeP-C study assessing the original Cologuard, which ultimately led the American Cancer Society (2018) and US Preventive Services Task Force (2021) to include stool DNA testing in their colorectal cancer screening guidelines.3,4,5

The Business Impact

Although the scientific community will likely want to see more data, the reported high specificity and sensitivity of next-generation Cologuard dazzled some in the financial industry. “In our view, the next-generation Cologuard results should support the company’s long-term path to 50 percent market share (or above),” noted Canaccord Genuity financial analyst Kyle Mikson in a report quoted in Investor’s Business Daily. However, others in the sector take a more conservative view.6 “The strength of these results has made investors hopeful that Cologuard will be able to fend off upcoming competition in the colorectal cancer screening market, but we still believe blood-based liquid biopsies hold significant promise versus the stool-based options,” wrote Julie Utterback, a senior equity analyst for financial services firm Morningstar. She adds that, due to the potential for increased competition in the colorectal cancer screening market, Exact Sciences shares “remain moderately overvalued.”7

Exact Sciences stock has been on a steady climb since October.8 In May, it received a further boost when the company announced a 24 percent increase in year-over-year Q1 revenues and raised its full-year guidance.9 The BLUE-C study report added even more momentum, with next-generation Cologuard expected to launch in 2024.

More Strategic Moves

On the same day it released the next-generation Cologuard data, Exact Sciences announced that it had entered into strategic research agreements to boost its position in two of the cancer market’s most dynamic sectors: molecular residual disease and multi-cancer early detection (MCED).

The first deal is a five-year sponsored research agreement with the Broad Institute of MIT and Harvard giving Exact Sciences an exclusive license to MAESTRO (Minor Allele Enriched Sequencing Through Recognition Oligonucleotides), Broad’s circulating tumor DNA detection technology. MAESTRO uses minimal sequencing and advanced biometrics capable of detecting thousands of different patient-specific mutations.

The company also advanced its nascent MCED test by partnering with Texas healthcare system Baylor Scott & White (BSW). Together, they agreed to establish the Texas Multicancer Early Detection Registry program, under which BSW will offer the test to thousands of patients, enabling Exact Sciences to gather real-world evidence to support its efforts to win acceptance for the test from regulatory agencies, payers, and organizations like the American Cancer Society that develop testing guidelines.10


  1. https://www.cologuard.com/faq/is-cologuard-fda-approved
  2. https://www.exactsciences.com/Pipeline-and-Data/next-generation-cologuard
  3. https://www.nejm.org/doi/full/10.1056/nejmoa1311194
  4. https://acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21457
  5. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening
  6. https://www.investors.com/news/technology/exas-stock-has-surged-since-october-why-this-news-could-stoke-it-again/
  7. https://www.morningstar.com/stocks/xnas/exas/quote
  8. https://ca.finance.yahoo.com/quote/EXAS
  9. https://investor.exactsciences.com/investor-relations/press-releases/press-release-details/2023/Exact-Sciences-Announces-First-Quarter-2023-Results/default.aspx
  10. https://www.exactsciences.com/newsroom/press-releases/exact-sciences-advances-innovative-cancer-technologies-and-approaches-through-visionary


Here’s a summary of other key diagnostic deals announced in late June through July 2023:

Strategic Alliances, Partnerships, and Collaborations

Partner 1 Partner(s) 2+ Deal Summary
Quest Diagnostics Envision Sciences ·       Objective: Develop and launch biomarker test to identify and differentiate potentially aggressive cases of prostate cancer
·       Dynamic: Intellectual property license agreement gives Quest right to use Envision’s biomarker and immunohistochemistry technology to develop and validate test
·       Quest has completed test and launched it via its AmeriPath pathology business
Beckman Coulter Fujirebio ·       Objective: Develop blood-based tests for Alzheimer’s disease
·       Dynamic: Fujirebio to develop tests on Beckman Coulter’s Access immunoassay analyzers, with initial focus on Dxl 9000 Access Immunoassay Analyzer
·       Fujirebio to validate clinical performance of neurodegenerative markers in blood and bring them through regulatory processes in US, Europe, and Japan
AccuStem Sciences EmeritusDx ·       Objective: Jointly develop AccuStem’s StemPrintER recurrence predictor assay for breast cancer patients
·       Dynamic: Further validate assay in guiding breast cancer treatment, including surgical intervention, with firms to jointly manage scientific and R&D operations for AccuStem’s product portfolio, including StemPrintER
Tempus AstraZeneca ·       Objective: Create multiomics dataset to support future research involving biomarkers, precision medicine, and diagnostic development
·       Dynamic: Perform GEMINI Non-small Cell Lung Cancer (NSCLC) study, with Tempus to use its solid tumor test, liquid biopsy, and investigational minimal residual disease assay to analyze molecular profiles of NSCLC patients
Tempus TScan Therapeutics ·       Objective: Develop companion diagnostic test to prospectively assess human leukocyte antigen loss in patient tumors
·       Dynamic: TScan to enroll patients with solid tumors including non-small cell lung cancer, melanoma, head and neck cancer, ovarian cancer, and cervical cancer; Tempus to use its xT assay, a 648-gene sequencing panel, to select most appropriate immunotherapies for patients
Cumulus Neuroscience University of Bath + University of Bristol ·       Objective: Develop “Fastball” electroencephalogram (EEG) test for early detection of Alzheimer’s disease (AD)
·       Dynamic: Carry out largest AD study to date on over 1,000 patients
·       Collaboration funded by £1.5m ($1.9m) Invention for Innovation (i4i) grant from UK National Institute for Health and Care Research
Mainz Biomed Fugene Genetics ·       Objective: Launch Mainz’s ColoAlert at-home colorectal cancer test in Israel
·       Dynamic: Market test via Fugene’s commercial network and relationships with leading labs in Israel
·       Mainz signed similar deals this year to market test in Germany, UK, and Spain
Massive Bio CureMatch ·       Objective: Use respective AI decision platforms to eliminate disparities and improve access to cancer clinical trials and precision oncology treatments
·       Dynamic: Combine CureMatch’s decision support platform for molecular tumor profile-based cancer treatment selection with Massive Bio’s AI platform to process data from CureMatch reports and match patients to clinical trials
BPGBio Grupo Terralpe ·       Objective: Commercialize pstateDx prostate cancer test in Mexico
·       Dynamic: Filamin A blood test helps physicians differentiate between benign prostatic hyperplasia and aggressive prostate cancer
Tasso United BioSource ·       Objective: Simplify, facilitate, and improve sample collection and analysis for patients taking part in clinical trials
·       Dynamic: Leverage Tasso’s at-home blood sampling solutions in collaboration with United BioSource’s evidence development and participant support services and its real-world data infrastructure and analytics software
Cardio Diagnostics Holdings (CDH) RiverRock Medical ·       Objective: Add CDH’s Epi+Gen CHD and PrecisionCHD epigenetic heart disease risk and detection tests to RiverRock’s concierge health offerings
·       Dynamic: Make CDH’s tests available to RiverRock Medical patients and its Actionable Clinical Intelligence platform available to RiverRock’s healthcare providers
DiamiR Biosciences JADBio ·       Objective: Develop predictive models of Alzheimer’s disease and Rett syndrome
·       Dynamic: DiamiR can use JADBio’s automated machine learning platform and services to develop predictive models based on DiamiR’s microRNA panels
Exact Sciences Baylor Scott & White (BSW) ·       Objective: Launch Exact’s new multicancer early detection test
·       Dynamic: Texas health system BSW to establish Texas Multicancer Early Detection Registry program offering the Exact test to some of its primary care clinics to generate real-world evidence to gain support for the test from regulatory agencies, payers, and guideline bodies
Diatech Pharmacogenetics Janssen Pharmaceuticals ·       Objective: Improve access to precision medicine for bladder cancer patients
·       Dynamic: Janssen to support Diatech’s efforts to develop in vitro diagnostic assay to guide use of precision medicine therapies for bladder cancer based on tumor molecular profiling
GeneDx Prognos Health ·       Objective: Improve ability to match newly diagnosed rare disease patients with FDA-approved medications
·       Dynamic: Integrate GeneDx whole genome and whole exome sequencing data into Prognos Marketplace, where pharma companies, providers, and researchers purchase custom patient cohorts

Distribution, Sales, and Marketing Agreements

Product Owner Distributor Deal Summary
Vela Diagnostics Eurobio Scientific ·       Products: Vela’s NGS panels for oncology, microbiology, and virology, as well as qPCR workflow with 31 tests
·       Territories: UK, France, Germany, Belgium, Netherlands, Luxembourg
BioSkryb Genomics BIOKÉ ·       Products: BioSkryb Genomics’ ResolveDNA and ResolveOME™ system for whole genome and whole transcriptome analysis in individual cells
·       Territories: Netherlands, Belgium, Luxembourg, Denmark, Norway, Sweden, Finland
Twist Bioscience MyBio ·       Products: Twist’s synthetic DNA and next-generation sequencing products
·       Territories: Ireland
·       Exclusive distribution agreement
INOVIQ Promega ·       Products: Combined offering of INOVIQ’s EXO-NET® exosome capture technology and Promega’s nucleic acid purification systems
·       Territories: Global
·       Three-year joint co-marketing agreement with automatic one-year renewals unless terminated by either company, with expectation to expand agreement to additional exosome isolation tools, characterization and analysis kits, and instruments
Congenica NoorDx ·       Products: Congenica’s sample-to-report services, including sequencing data analysis and interpretation and geneticist support
·       Territories: Middle East
Genomic Vision CliniSciences ·       Products: Genomic Vision’s molecular combing technology, products, and services
·       Territories: 15 European countries
·       Exclusive distribution agreement


Licensor Licensee Deal Summary
Broad Institute Exact Sciences Five-year sponsored research agreement giving Exact Sciences exclusive license to proprietary molecular residual disease testing technology
Twist Bioscience Cancer Research Horizons Translational arm of Cancer Research UK licenses entire Twist Biopharma Solutions “Library of Libraries” in exchange for library access fee and ability to receive annual maintenance fees, share of revenue from any assets sold or transferred

Government Contracts

Contractor Govt. Agency Contract Summary
Advanced BioScience Laboratories US National Institutes of Health’s National Institute of Allergy and Infectious Diseases Seven-year contract worth up to $12 million for development, documentation, and production of custom recombinant proteins and monoclonal antibodies for use in in vitro diagnostic assays

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