Labs Partner with Pharma Companies to Develop New CDx Tests

There is often a significant lag between the launch of novel drugs and treatments and their adoption for actual clinical use. After all, it takes time for new products to gain the recognition of providers, patients, and payors. Pharmaceutical companies have sought to speed up the cycle by forming strategic alliances with diagnostics companies. The objective of these companion diagnostics (CDx) collaborations is for the lab company to develop and commercialize new lab tests that can identify individuals who may benefit from the use of the novel therapeutic drugs and treatments created by the pharma company partner.

The CDx model appears to be a win-win, with pharma companies seeing a return of at least $30 in therapeutics revenues for every dollar invested in diagnostics, according to a study from precision medicine analysis firm Diaceutics (cited in Diagnostic Testing and Emerging Technologies, August 17, 2017).¹ Pharma firms actively involved in precision medicine CDx collaborations include AstraZeneca, Amgen, Novartis, Roche/Genentech, Pfizer, Bristol Myers Squibb, and Merck.

Meanwhile, the diagnostics companies are responsible for discovering, validating, commercializing, and supplying the CDx test. They typically have little to no business stake in the drug but instead receive hefty payments from the pharma company, which may be in the form of front-loaded payments for development, royalties on each drug sold as a result of the CDx, or a combination of both.

There were three notable CDx alliances announced in January 2023.

Thermo Fisher Scientific + AstraZeneca for NSCLC Drug CDx

AstraZeneca’s keen interest in CDx partnerships isn’t hard to understand given that precision medicine treatments make up over 90 percent of its clinical pipeline—including drugs for cancer, cardiovascular, renal, metabolic, and respiratory diseases. In 2021, AstraZeneca enlisted Thermo Fisher Scientific to codevelop next-generation sequencing-based (NGS) companion diagnostics for its personalized medicine drug products.

As part of that long-term agreement, the firms announced on January 24, 2023, a new partnership to develop a CDx test for AstraZeneca’s non-small cell lung cancer (NSCLC) drug Tagrisso (osimertinib). The plan calls for leveraging Thermo Fisher’s Oncomine Dx Express Test on the Genexus Dx System, a fully integrated NGS platform to create a solid tissue, blood-based test to screen for NSCLC patients who may be eligible for Tagrisso treatment by identifying tumors that exhibit epidermal growth factor receptor (EGFR) alterations.

“By leveraging the Genexus Dx System’s unprecedented turnaround time, we can help ensure molecular testing results are more readily available to inform vital treatment decisions,” noted Garret Hampton, Thermo Fisher’s president of clinical next-generation sequencing and oncology in a statement.²

Foundation Medicine + Boehringer Ingelheim for Biliary Tract Cancer Drug CDx

Having secured FDA approval for a pair of CDx tests for all solid tumors—FoundationOneCDx and FoundationOneLiquid CDx—Roche subsidiary Foundation Medicine has been a go-to for pharma companies seeking to commercialize new cancer therapies. On Jan. 19, Foundation Medicine unveiled its latest CDx venture, a collaboration with Boehringer Ingelheim (BI) to develop the tissue-based FoundationOne CDx test as a companion diagnostic to BI’s biliary tract cancer drug BI 907828. The investigational oral drug is currently being evaluated for treatment of patients with certain forms of advanced or metastatic biliary tract cancer marked by amplifications of small molecule MDM2 antagonists in a Phase IIa/IIb multicenter clinical trial.

“High quality, well-validated genomic testing is critical to identify biliary tract cancer patients with complex alterations like MDM2 amplifications,” according to Foundation Medicine chief biopharma business officer, Sanket Agrawal, in the press statement announcing the deal.³

Foundation Medicine + Karyopharm for Endometrial Cancer Drug CDx

Earlier in the month, Foundation Medicine announced that it was partnering with fellow Massachusetts firm Karyopharm Therapeutics to turn FoundationOneCDx into an NGS-based CDx test to identify patients who would be eligible to enroll in a Phase III clinical trial evaluating Xpovio (selinexor), the pharma firm’s experimental drug for treating advanced or recurrent TP53 wild-type endometrial cancer. The companies pointed out that endometrial cancer is the most common female reproductive cancer in the US, and that about 50 percent of patients who have advanced or recurrent forms of the disease have p53 wild-type tumors. Xpovio is an exportin 1 (XPO1) inhibitor that would be used as a maintenance therapy after systemic therapy for the cancer.⁴

References:

1. https://www.g2intelligence.com/companion-diagnostics-driving-new-model-for-pharma-dx-partnerships/
2. https://www.businesswire.com/news/home/20230124005356/en/Thermo-Fisher-Scientific-Partners-with-AstraZeneca-to-Develop-Solid-Tissue-and-Blood-Based-Companion-Diagnostic-Test-for-Tagrisso
3. https://www.businesswire.com/news/home/20230118006003/en/Foundation-Medicine-Announces-Global-Collaboration-with-Boehringer-Ingelheim-to-Advance-Biliary-Tract-Cancer-Care
4. https://www.businesswire.com/news/home/20230110005421/en/Foundation-Medicine-Announces-Collaboration-with-Karyopharm-Therapeutics-to-Develop-FoundationOne%C2%AECDx-as-a-Companion-Diagnostic-for-XPOVIO%C2%AE-selinexor

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Here’s a summary of key strategic diagnostic deals announced in January 2023:

STRATEGIC ALLIANCES, PARTNERSHIPS, & COLLABORATIONS

Partner 1	Partner(s) 2+	Deal Summary
Quest Diagnostics	Agilent Technologies	• Objective: Have Quest offer Agilent's liquid biopsy test to guide non-small cell lung cancer (NSCLC) treatment • Dynamic: Give Quest customers access to Agilent's Resolution ctDx FIRST next-generation sequencing-based companion diagnostic to determine which patients are likely to benefit from Mirati Therapeutics' Krazati (adagrasib) to treat adults with KRAS G12C-mutated locally advanced or metastatic NSCLC
Thermo Fisher Scientific	AstraZeneca	• Objective: Develop solid tissue and blood-based companion diagnostic test for AstraZeneca’s Tagrisso (osimertinib) NSCLC drug • As part of 2021 global, multiyear CDx agreement, use Thermo Fisher’s Oncomine Dx Express Test on the Genexus Dx System to help screen for NSCLC patients eligible for Tagrisso treatment
C2i Genomics	AstraZeneca	• Objective: Evaluate C2i Genomics' whole-genome minimal residual disease (MRD) assay and cancer-monitoring platform for use in clinical research and drug development • Dynamic: Extension of a previous collaboration in which firms evaluated C2i Genomics' MRD test across multiple solid cancers using artificially generated samples
Tempus	AstraZeneca	• Objective: Identify biomarkers of response in small cell lung cancer (SCLC) patients • Dynamic: Perform study, called Sculptor, pulling from Tempus' line of molecular profiling services to detect individuals who might benefit from an emerging therapy or targets for development of a new SCLC therapy
Laboratory Corporation of America	VieCure	• Objective: Further utilization of precision diagnostics and personalized treatment plans for cancer in community health settings • Dynamic: Integrate VieCure’s AI-backed clinical decision support software with Labcorp’s menu of next-generation sequencing tests for cancer diagnosis
Foundation Medicine (Roche subsidiary)	Boehringer Ingelheim (BI)	• Objective: Develop companion diagnostic for BI’s biliary tract cancer drug • Dynamic: Turn tissue-based FoundationOne CDx test into a companion diagnostic for BI 907828 in US, Japan, and EU
Foundation Medicine	Natera	• Objective: Launch early access program for the investigational and clinical use of FoundationOne Tracker, a personalized circulating tumor DNA (ctDNA) monitoring assay • Dynamic: Combine genomic information from FoundationOne CDx with Natera's personalized assay design and ctDNA analysis to allow physicians to serially monitor cancer patients' response to immunotherapy and other treatments using a simple blood draw, and then use findings to optimize treatment decisions
Foundation Medicine	Karyopharm Therapeutics	• Objective: Develop companion diagnostic for Karyopharm's experimental drug Xpovio (selinexor) for patients with advanced or recurrent TP53 wild-type endometrial cancer • Dynamic: Use FoundationOne CDx next-generation sequencing test to help identify patients with TP53 wild-type tumors so they can be enrolled into Karyopharm's Phase III clinical study on use of Xpovio, an exportin 1 (XPO1) inhibitor, as a maintenance therapy following systemic therapy
Guardant Health	Royal Marsden NHS Foundation Trust	• Objective: Evaluate use of circulating tumor DNA to guide chemotherapy treatment decisions after curative-intent surgery in early-stage colorectal cancer patients • Dynamic: Multicenter, prospective, randomized trial to assess if the company's Guardant Reveal assay can accurately identify patients that can be spared unnecessary chemotherapy and side effects based on a negative blood test result after tumor is surgically removed
Atomo Diagnostics	NG Biotech	• Objective: Manufacture and distribute blood-based pregnancy tests for use in homes and clinical settings • Dynamic: Test to combine NG Biotech's assay for human chorionic gonadotropin (hCG) levels with Atomo's integrated Pascal blood testing instrument • 5-year deal with Atomo to provide NG Biotech exclusive license to use Pascal devices to manufacture rapid pregnancy tests • Atomo gets exclusive rights to distribute the tests in Australia, Canada, New Zealand, and US
Freenome	Geisinger	• Objective: Perform Sanderson Study assessing Freenome’s multi-cancer screening technology in certain high- or elevated-risk populations • Dynamic: Study to validate Freenome’s test combining tumor and non-tumor signals with machine learning to detect cancer in its earliest stages from a standard blood draw
Paige	Microsoft	• Objective: Develop AI technology clinical applications and computational biomarkers for digital pathology images • Dynamic: Scale Paige’s technology globally and accelerate the adoption of AI in digital pathology by using Microsoft Azure as cloud provider for Paige Platform • Paige to Paige will become a Microsoft Cloud for Healthcare partner enabling Microsoft to expand its healthcare offerings • Microsoft to also make a strategic investment in Paige
Bionano Genomics	Nvidia	• Objective: Create platform to improve data processing speed to cut the time and cost of secondary data analysis for Bionano’s optical genome mapping (OGM) workflow • Dynamic: Combine Nvidia’s RTX 6000 Ada Generation GPU with Bionano’s OGM products to develop on-premise and cloud-based solutions to keep pace with anticipated data generation needs of high-throughput OGM workflows
SOPHiA GENETICS	Memorial Sloan Kettering Cancer Center	• Objective: Provide new testing and analytical capabilities to cancer researchers and clinicians • Dynamic: Combine predictive algorithms as part of larger collaboration for predictive tumor analysis and clinical decision support • Sophia to also help commercialize MSK-ACCESS clinical liquid biopsy assay, which will be first ctDNA panel to be integrated with Sophia’s flagship DDM analytics platform • Sophia to also build a new cloud-based clinicogenomics module for its CarePath multimodal analytics platform and pair it with MSK’s comprehensive genomic panel sequencing tests
Caris Life Sciences	ConcertAI	• Objective: Create translational and clinical development research platform to support molecular oncology R&D in biopharma • Dynamic: Combine Caris’ multiomic work on tumor biology and molecular biomarkers with ConcertAI’s collection of multimodal clinical data in oncology and hematology to offer unified platform for uncovering novel signatures, targets, and therapeutics
Helix	Mayo Clinic Laboratories	• Objective: Provide lab R&D services to biopharma customers • Dynamic: Build upon the partners’ co-sponsored Tapestry study, an ongoing clinical genomics study of the impact of genetic testing on individual's short- and long-term health care
Helix	Qiagen	• Objective: Develop and commercialize companion diagnostics for hereditary diseases • Dynamic: Exclusive global partnership to leverage Helix's whole-exome sequencing platform to develop companion diagnostics and early-stage assays in the US for clinical trials • Qiagen to use its QiaSeq Human Exome Kits in the rest of world and incorporate its biopharma relationships, next-generation sequencing capabilities, and global regulatory expertise
Agilent Technologies	Akoya Biosciences	• Objective: Develop multiplex-immunohistochemistry diagnostic solutions for tissue analysis and commercialize end-to-end workflow tools for multiplex assays for biopharma companies • Dynamic: Combine Agilent's Dako Omnis autostaining instrument with Akoya's PhenoImager HT imaging platform for multiplex chromogenic immunohistochemistry and immunofluorescent assays • Includes value-added reseller agreement allowing Akoya to distribute and resell Agilent's Dako Omnis
Lucira Health	Sesame	• Objective: Provide COVID-19 test-to-treat services • Dynamic: Partnership to enable people who purchase Lucira's molecular COVID-19 test to access telehealth consultations from Sesame • Consultation to be offered via Lucira Connect web-based virtual care platform
Prostatype Genomics	Life Genomics	• Objective: Commercialize Prostatype gene-based prostate cancer test • Dynamic: Nonexclusive deal with Life Genomics to manage the test process in all Nordic countries

DISTRIBUTION, SALES, & MARKETING AGREEMENTS

Product Owner	Distributor	Deal Summary
Caris Life Sciences	Juniper Biologics	• Products: Caris’ comprehensive molecular profiling services, including whole-exome and transcriptome sequencing • Territory: Southeast Asia
S2 Genomics	Bonsai Lab	• Products: S2 Genomics’ Singulator 100 and Singulator 200 tissue dissociation systems • Territory: Spain and Portugal
ProtonDx	Katalyst Laboratories	• Products: ProtonDx’s Dragonfly rapid in vitro diagnostic system • Territory: Undisclosed • Exclusive

LICENSES

Licensor	Licensee	Deal Summary
UCB	Pheno Therapeutics Limited	Pheno gets exclusive worldwide license to develop, manufacture, and commercialize a preclinical-stage program of novel small molecules designed to promote remyelination
Synaffix	Hummingbird Bioscience	Synaffix to provide Hummingbird Bio access to its antibody drug conjugate (ADC) technologies for the unnamed licensed target in exchange for up to $150 million in upfront and milestone payments plus potential royalties

GOVERNMENT CONTRACTS

Contractor	Govt. Agency	Contract Summary
Quidel + Access Bio + iHealth Labs + Orasure Technologies	U.S. Department of Defense	One-year, $803 million indefinite-delivery/indefinite-quantity contract to produce over-the-counter rapid antigen COVID-19 test kits, with the four companies to split the proceeds