Partnership to Promote Multi-Ancestry PRS Breast Cancer Testing
Genomics software developer Allelica to collaborate with Taiwanese precision medicine firm to develop a multi-ancestry breast cancer test.
Genomics software developer Allelica has been a leader in expanding access to polygenic risk score (PRS) tests for predicting an individual’s genetic risk of developing certain diseases. On Feb. 22, Allelica unveiled its newest strategic venture: a collaboration with Taiwanese precision medicine firm SP BioMED to develop a multi-ancestry PRS breast cancer test.
The Promise of PRS Technology
Genetic factors play a crucial role in the development of many common diseases, including diabetes, cancer, and heart disease. Genome-wide association studies (GWAS) have identified genetic variants that can significantly increase an individual’s risk. PRS tests calculate a person’s risk for a particular disease by adding the number of genetic risk variants an individual has, weighted by the size of the variant’s effect. By combining PRS with physical and social environmental risk factors, risk can be stratified more effectively.
However, there’s currently not strong evidentiary support for the routine use of PRS tests in medical practice. Stated simply, nobody has yet figured out how best to integrate PRS testing into health care. In addition, genomic databases allowing for the development, validation, and implementation of PRS tests have historically been limited to mostly European ancestry populations.
The Allelica-SP BioMed Collaboration
With offices in New York City, London, and Rome, Allelica was founded to promote wider use of PRS for precision medicine by making the technology more scalable, affordable, and accessible to a wider population of ancestries. To that end, Allelica is partnering with SP BioMED on a PRS breast cancer study to determine the optimal genotyping technology for genome-wide data generation.
The plan is to come up with a PRS breast cancer calculation for the Taiwanese population by using PREDICT, a software for applying PRS across multiple ancestries that Allelica developed in collaboration with Invitae last year, to analyze 856 Taiwanese breast cancer samples genotyped by SP BioMED using three different platforms: the Thermo Fisher Axiom Genome-Wide TPM 2.0 Array Plate (Taiwan Precision Medicine V2.0), whole-genome sequencing (WGS) at 30X coverage, and WGS at 2X coverage.
“Working together with local providers like SP BioMed to identify the most appropriate technology to drive the development of better medicine across diverse populations is one of Allelica’s top priorities,” noted Allelica chief scientific officer George Busby in a statement.1
Allelica will add the study samples it analyzes to its Federated Learning Initiative (FLI) program that the company created to enable its various collaborators to develop more inclusive PRS models without having to share their data. Allelica will use the FLI to launch the PRS Alliance, an organization dedicated to developing accurate PRS that works for any individual, regardless of ancestry or ethnicity.
Last November, Allelica partnered with the University of Alabama at Birmingham (UAB) Cardiogenomics Clinic to furnish multi-ancestry PRS testing for a study evaluating the real-world value of PRS in helping to prevent coronary artery disease (CAD). In addition to breast cancer and CAD, the firm offers multi-ancestry PRS analysis for prostate cancer, type 2 diabetes, and Alzheimer’s disease.
Multi-ancestry PRS testing is a small but growing market thanks to recent advances in genomic research and PRS clinical validation. In addition to Allelica, key players in the space include Myriad Genetics, which launched its PRS breast cancer RiskScore test in 2017 and has since made several refinements, and personalized genomics company MyOme, which recently rolled out its own multi-ancestry breast cancer PRS test.
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Here’s a summary of other key strategic diagnostic deals announced in February 2023:
Strategic Alliances, Partnerships, & Collaborations
| Partner 1 | Partner(s) 2+ | Deal Summary |
| Roche | Janssen Biotech | · Objective: Create companion diagnostics for Janssen Biotech targeted therapies · Dynamic: Expansion of existing collaboration to new technologies, including immunohistochemistry, digital pathology, next-generation sequencing, PCR, and immunoassays |
| Roche Diagnostics | Jana Care | · Objective: Develop blood tests for chronic kidney disease and heart failure · Dynamic: Roche to distribute Jana Care’s at-home testing platform, which allows patients to self-administer blood tests using fingerstick samples and clinicians to remotely review the tests |
| Guardant Health | AnHeart Therapeutics | · Objective: Develop and commercialize Guardant360 CDx and Guardant360 TissueNext assays as companion diagnostics for use of taletrectinib in adults with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) · In 2022, FDA granted breakthrough therapy designation for taletrectinib along with premarket approval for use of Guardant360 CDx as a companion diagnostic to Enhertu (trastuzumab deruxtecan), also for NSCLC |
| Guardant Health | Lunit | · Objective: Create Guardant360 TissueNext PD-L1 test integrating Lunit’s AI-based PD-L1 scoring algorithm into Guardant Health’s tissue testing offering · Dynamic: Integration augments Guardant’s existing biomarker assessment for NSCLC patients with improved detection of PD-L1 positive tumors |
| M2GEN | Zephyr AI | · Objective: Advance target and drug discovery for precision oncology treatments · Dynamic: Multiyear agreement with M2GEN to license its real-world longitudinal cancer patient dataset to Zephyr AI, allowing Zephyr to apply its AI and machine learning technologies to data |
| GenScript | Indee Labs | · Objective: Develop and comarket a DNA knock-in kit using Indee’s Hydropore non-viral intracellular delivery technology · Dynamic: Indee to optimize the technology for use with GenScript single-strand and double-strand constructs by evaluating functional differences between T cells processed with Hydropore and electroporation · Kit to be used for large transgene inserts for non-viral CRISPR gene editing in immune and other cells |
| Quest Diagnostics | Cleveland Diagnostics | · Objective: Expand access to Cleveland’s IsoPSA prostate cancer test · Dynamic: Tests ordered via Quest network to be processed in the Cleveland lab with patients to provide blood samples at a Quest patient service center for Quest to transport to the Cleveland lab |
| LetsGetChecked | Jeffrey Modell Foundation | · Objective: Test thousands of children worldwide for primary immunodeficiency disorders · Dynamic: Allow the more than 900 physician members who are part of Jeffrey Modell Centers Network to offer genomic sequencing services from Veritas (a company that LetsGetChecked acquired last year) to patients suspected of having a primary immunodeficiency to identify possible genetic mutations |
| Genomenon | Flagship Biosciences | · Objective: Optimize clinical trials and treatment selection and advance precision medicine and drug discovery · Dynamic: Leverage Genomenon’s MastermindTM knowledgebase of disease-specific genomic datasets to bolster Flagship’s genomic profiling services, resulting in accelerated biomarker discovery and companion diagnostics development solutions |
| Bio-Rad | Element Biosciences | · Objective: Demonstrate the Bio-Rad SEQuoia RNA sequencing library preparation portfolio on Element’s AVITI benchtop sequencer · Dynamic: Adapt Element AVITI sequencing platform’s chemistry for use with the Bio-Rad SEQuoia Complete Stranded RNA Library Prep Kit and SEQuoia Express Stranded RNA Library Prep Kit to obtain RNA sequencing accuracy and repeatability among samples and different RNA inputs |
| Personalis | Moderna | · Objective: Advance Moderna Phase IIb KEYNOTE-942 trial to develop an mRNA-based cancer vaccine · Dynamic: Trials to use Personalis NeXT platform to sequence patient tumor DNA to identify genetic mutations most likely to generate a tailored antitumor immune response |
| NanoString Technologies | Weill Cornell Medicine | · Objective: Create multiomic spatial maps of healthy human tissues from multiple organs · Dynamic: 3-year project to map 250 million cells using both of NanoString’s spatial transcriptomics platforms: the GeoMx Digital Spatial Profiler and the CosMx Spatial Molecular Imager · Undisclosed amount of funding to be provided by Weill Cornell, the Gastro-Intestinal Research Foundation, and WorldQuant Foundation · NanoString to provide in-kind reagent support |
| Beckman Coulter Diagnostics | MeMed | · Objective: Develop and commercialize host immune response diagnostic test · Dynamic: Beckman Coulter to develop and co-promote MeMed BV test for use with Beckman Coulter’s Access line of immunoassay analyzers |
| Biological Dynamics | Perlmutter Cancer Center at New York University Langone Health | · Objective: Validate Biological Dynamics’ exosome-isolation platform for detecting pancreatic cancer · Dynamic: Test retrospective samples from over 200 patients using the ExoVerita platform to validate platform’s application for the early detection of pancreatic ductal adenocarcinoma |
Distribution, Sales, & Marketing Agreements
| Product Owner | Distributor | Deal Summary |
| MedMira | Maternova | · Products: MedMira’s Reveal, Multiplo, and Miriad lines of point-of-care infectious disease immunoassays · Territory: Latin America (exclusive), US (nonexclusive) |
| Mainz Biomed | Marylebone Laboratory | · Products: Mainz Biomed’s ColoAlert colorectal cancer early detection test · Territory: UK |
| Mainz Biomed | Instituto de Microecologia | · Products: Mainz Biomed’s ColoAlert colorectal cancer early detection test · Territory: Spain |
| Salignostics | Abingdon Health | · Products: Salignostics’ Salistick saliva-based pregnancy test · Territory: UK and Ireland · Test to be cobranded under Abingdon Simply Test menu, and offered via Abingdon’s e-commerce platform |
Licenses
| Licensor | Licensee | Deal Summary |
| Arima Genomics | Pierian (part of Velsera) | Comarketing and licensing agreement allowing Velsera to integrate Arima Genomics’ targeted NGS testing pipelines into cloud-based Pierian Clinical Genomics Workspace |
Government Contracts
| Contractor | Govt. Agency | Contract Summary |
| SeqLL | US Federal Bureau of Investigation (FBI) | 2-year Cooperative Research and Development Agreement (CRADA) to develop an assay for forensic body fluid identification using the company’s True Single Molecule Sequencing platform |
| BioFire Defense (BioMérieux subsidiary) | U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) | Contract to support expansion of BioMérieux subsidiary Specific Diagnostics’ SPECIFIC Reveal Rapid AST System test menu to include panels for gram-positive and gram-negative bacterial, fungal, and streptococcal blood infection samples and isolates |
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