Exact Sciences Ends Cologuard Co-promotion Partnership with Pfizer

One of the most dynamic and significant marketing arrangements in the genetic cancer lab testing market over the last few years is coming to an end. On Nov. 30, Exact Sciences told investors it is ending its collaboration with Pfizer to co-promote the firm’s flagship Cologuard colorectal cancer screening test. Not only will Pfizer stop co-promoting Cologuard to labs and other health care providers, but will also stop selling the test.

The Rise & Fall of the Cologuard Collaboration

In 2014, Cologuard became the first FDA-approved non-invasive DNA screening test for colorectal cancer. The American Cancer Society included the product in its 2018 colorectal cancer screening guidelines and many payors cover it. While it now has competition, Cologuard remains the clear leader in the at-home colorectal cancer screening market with over 254,000 providers having ordered the test since its launch. Cologuard has also benefited from highly successful marketing. A turning point came in August 2018 when Exact Sciences announced that it had enlisted Pfizer to co-promote the test. The agreement, which ran through the end of 2021, enabled Exact to work with Pfizer’s seasoned sales force and promotion network to persuade providers and health systems to use Cologuard. Exact maintained responsibility for all aspects of Cologuard manufacturing and lab operations, while Pfizer paid a share of the marketing expenses and received 50 percent of gross profits above an agreed baseline. Although the collaboration has been largely successful, it remained unclear whether the arrangement would be renewed when it expired at the end of this year. In announcing its Q3 2021 earnings, Exact noted that Cologuard sales for the quarter grew less than expected, attributing the disappointing sales to rising COVID-19 cases and “actions taken by Pfizer” in pulling its sales reps out of the field in late July and then reducing the size of its internal medicine team in mid-September. “Combined, the Delta variant and our partner Pfizer's decision caused our in-person sales calls to decrease 70 percent during this time period,” according to Kevin Conroy, Exact’s chairman and CEO. A month earlier, Exact announced that it had nearly doubled its field sales team to 850 by hiring approximately 400 new sales representatives, many of whom were former Pfizer sales reps assigned to promoting Cologuard that had lost their jobs. Exact also let it be known that it was in talks with Pfizer about making significant changes to the co-promotion agreement up for renewal. But instead of renewing, Exact has decided to end the co-promotion agreement. The firms will work together to wind down the arrangement over the first three quarters of 2022. In its recent SEC Form 8-K, Exact disclosed that it will pay Pfizer $35.9 million in three installments during 2022, and that it will no longer be obligated to pay the pharmaceutical giant royalties or other fees (other than certain media and advertising fees) for promoting Cologuard before Nov. 30. Pfizer will also continue to purchase advertising for Cologuard on Exact's behalf through the third quarter of 2022, while supporting the transition of ad purchasing responsibilities to Exact. Here’s a summary of some of the other key strategic diagnostic deals announced in December 2021:

Strategic Alliances, Partnerships & Collaborations

Partner 1	Partner(s) 2+	Deal Summary
SkylineDx	VIB (Belgian life science research institute)	Objective: Develop new molecular diagnostics for unmet medical needs Dynamic: Three-year partnership to combine VIB’s single-cell analysis and biomarker discovery expertise with SkylineDx’s global network of clinical centers and physicians
LumiraDx	Audere	Objective: Offer at-home COVID-19 specimen collection kit for use with LumiraDx’s SARS-CoV-2 test Dynamic: Integrate Audere’s testing solution, HealthPulse@home into lab systems using LumiraDx’s SARS-CoV-2 RNA STAR Complete test
Illumina	Gretel (data privacy firm)	Objective: Generate artificial genomic data for use in medical research Dynamic: Firms to provide researchers statistically accurate, artificial versions of genomic datasets that meet GDPR, CCPA and other privacy laws
Qiagen	Denovo Biopharma	Objective: Develop companion diagnostic (CDx) test to identify diffuse large B-cell lymphoma (DLBCL) patients expressing a biomarker Dynamic: Qiagen to develop test capable of detecting the Denovo Genomic Marker 1 (DGM1) in DLBCL patients, as well as a PCR CDx for use on its Rotor-Gene Q MDx instrument and seek FDA premarket approval for new test
Mainz Biomed	Ganzimmun Diagnostics	Objective: Commercialize Mainz Biomed’s ColoAlert colorectal cancer detection test Dynamic: Mainz Biomed to co-brand ColoAlert with Ganzimmun and sell its customized PCR assay kits to German stool lab on an on-demand basis
BostonGene	NEC	Objective: Offer BostonGene’s Tumor Portrait tests outside US for first time Dynamic: Provide test to hospitals in NEC’s home country of Japan and expand to other, unspecified international markets later In 2020, firms began collaboration to analyze molecular profiles and tumor microenvironments of cancer patients enrolled in NEC’s clinical trials
OncoHost	Heidelberg University Hospital (Germany)	Objective: Discover new lung cancer biomarkers Dynamic: OncoHost to collaborate with Lung Biobank Heidelberg to collect and analyze blood samples to identify novel biomarkers and therapeutic targets for lung cancer
Akoya Biosciences	PathAI	Objective: Identify and validate biomarkers for predicting patient response to cancer immunotherapies Dynamic: Combine Akoya's Phenoptics spatial biology platform and Advanced Biopharma Solutions (ABS) services with PathAI's artificial intelligence tools to identify predictive biomarkers
Pacific Biosciences	University of California, Los Angeles	Objective: Sequence patients with rare, undiagnosed pediatric diseases Dynamic: Study the effect of combining PacBio's HiFi long-read whole-genome sequencing and RNA isoform sequencing (Iso-Seq) on diagnostic yield in rare disease cases
Caris Life Sciences	Redx Pharma	Objective: Clinical trial recruitment Dynamic: Leverage Caris’ whole-transcriptome and whole-exome sequencing platform and right-in-time clinical trial solutions to boost US patient accrual for Redx’s Phase II trial of RXC004 investigational Porcupine inhibitor in colorectal cancer
Biodesix	Spesana	Objective: Automate use of molecular diagnostics in clinical workflows for lung cancer Dynamic: Spesana to integrate electronic ordering of Biodesix tests, including Nodify Lung and IQlung and provide clinical education and virtual engagement platform
LabCorp	ConcertAI	Objective: Optimize precision oncology clinical trials Dynamic: LabCorp to use ConcertAI’s artificial intelligence and real-world data platforms to design more effective and inclusive trials
Siemens Healthineers	Freenome	Objective: Identify blood-based biomarkers for breast cancer detection Dynamic: Use epigenetic, proteomic, genomic, immunologic, and other data to identify blood markers to complement current imaging technologies for early diagnosis
Genetron	AstraZeneca R&D	Objective: Jointly develop next-generation sequencing-based tumor-informed minimal residual disease tests for various solid tumor types in China Dynamic: Firms to invest capital to support validation of these personalized MRD assays for cancer monitoring and recurrence assays
GE Healthcare	Cambridge and Cambridge University Hospitals (UK)	Objective: Develop artificial intelligence-based app for precision cancer care Dynamic: Integrate clinical, imaging and genomic data from multiple sources into single interface for use by oncologists, surgeons, radiologists, pathologists and clinical nurse specialists to create personalized treatment plans for each patient
Radiomics	OncoDNA	Objective: Improve the biological understanding and treatment of non-small cell lung cancer (NSCLC) Dynamic: Combine firms’ expertise in machine learning-enabled analysis of medical images and molecular biomarker evaluation within the prospective Measure Lung Cancer Biology and Treatment Response via Imaging trial, dubbed SALMON, to validate Radiomics’ artificial intelligence-based medical imaging analysis technology and create a "radiomics atlas of oncogenic biomarkers"

Distribution, Sales & Marketing Agreements

Product Owner	Distributor	Deal Summary
DnaNudge	DAM Health	Products: DnaNudge’s COVID-19 PCR test Territory: UK, Spain, Mexico
Dotz Nano	ScienceVision	Products: Dotz Nano’s point-of-care SARS-CoV-2 testing platform, the Dotz Mega-Diagnostic Platform Territory: Malaysia
Dotz Nano	World Siam Group	Products: Dotz Nano’s point-of-care SARS-CoV-2 testing platform, the Dotz Mega-Diagnostic Platform Territory: Thailand
Cytena	Applitech Pharmaceutical Equipment Technology	Products: Cytena’s single-cell isolators Territory: China Two-year deal

Licenses

Licensor	Licensee	Deal Summary
Fred Hutchinson Cancer Research Center	EpiCypher	Co-exclusive license to CUT&RUN (Cleavage Under Targets and Release Using Nuclease) and CUT&Tag chromatin profiling technologies

Government Contracts

Contractor	Govt. Agency	Contract Summary
Yourgene Health	UK Department of Health and Social Care	Yourgene Genomic Services business to provide COVID-19 winter surge testing in UK through March 31, 2022