Lab Companies Team with Nonprofits on Test Development, Access, & Awareness
April was among the busiest months, in recent memory, in terms of both deal volume and significance in the diagnostics industry.
While merger and acquisition deals continue to lag, strategic alliances in the diagnostics space are running at a torrid pace. April was among the busiest months, in recent memory, in terms of both deal volume and significance. Continuing recent trends, several biotech and diagnostics companies announced new collaborations with nonprofit organizations aimed at developing new tests or expanding testing awareness and access among historically underserved populations.
Alpenglow Teams with Mayo Clinic for 3D Imaging of Immunotherapy Response
Examples of the former include the collaboration between Seattle-based biotech Alpenglow Biosciences and Mayo Clinic to advance clinical diagnostics and drug development. The plan is for Alpenglow (which used to be called Lightspeed Microscopy) to integrate its AI-based imaging and analysis platform for nondestructive 3D imaging of tissues at subcellular resolution with Mayo Clinic’s multiomics approaches. That includes combining the AI platform with multiplex immunofluorescence, single-cell sequencing solutions, and biospecimen repositories to predict therapy response and patient prognosis. Mayo Clinic will then analyze lung cancer samples from patients treated with immunotherapy to correlate 3D spatial data with treatment response.1
Mayo Clinic has a financial stake in the Alpenglow platform but plans to use any revenues it makes from the collaboration to support its nonprofit patient care, education, and research activities.
Illumina Partners with Henry Ford Health for Cardiac Care WGS Testing
Another newly announced partnership involves Illumina and Henry Ford Health. Under the collaboration, researchers at the Lisa and Christopher Jeffries Center for Precision Medicine and the Center for Individualized and Genomic Medicine Research at Henry Ford Health in Detroit, MI, will carry out clinical studies evaluating the clinical utility of next-generation sequencing and whole genome sequencing (WGS) in cardiac care. That research includes a 1,500-patient study called CardioSeq designed to use a WGS-based test developed by Illumina to create a “comprehensive cardiovascular genomic profile.”2
“What we’re initially most interested in is the rate of the change in medical management due to the genetic information, but eventually we will be looking at differences in cost and clinical outcomes, as well,” said David Lanfear, vice president of clinical and translational research at Henry Ford Health and leader of the CardioSeq study, in the statement.2
Illumina is hoping that data from the study will support the use of WGS testing for managing and treating cardiovascular disease. Last March, the San Diego-based provider of WGS cardiac tests formed a cardiac testing alliance with Fulgent Genetics, GeneDx, Invitae, and PerkinElmer.3
23andMe Teams with Morehouse to Promote Sickle Cell Disease Awareness
Diagnostics company/nonprofit ventures aimed at expanding access to testing include 23andMe’s collaboration with the Morehouse School of Medicine and Sickle Cell Foundation of Georgia. The partnership aims to promote awareness of sickle cell disease among genetic carriers of the condition that affects one of 13 Black people in the US, according to Morehouse.4
To carry out the venture, 23andMe will provide free Health+Ancestry DNA test kits—a product authorized by the FDA—that include a sickle cell anemia carrier status report on the sickle hemoglobin variant, to the faculty, students, and staff of Morehouse, a historically Black medical school located in Atlanta. After receiving their results, program participants will be offered counseling by the Sickle Cell Foundation.
“In addition to educating more people on their carrier status, genetic health risks, and potential risks for family members, we believe this collaboration can contribute to more equitable research in, and product development for, groups of non-European ancestry,” noted Joyce Tung, vice president for research at 23andMe, in the statement announcing the collaboration.5
References:
- https://www.prnewswire.com/news-releases/alpenglow-biosciences-and-mayo-clinic-enter-collaboration-agreement-to-advance-pathology-and-drug-development-through-3d-spatial-biology-301795226.html
- https://investor.illumina.com/news/press-release-details/2023/Illumina-and-Henry-Ford-Health-team-up-to-study-impact-of-comprehensive-genomic-testing-for-cardiovascular-patients/default.aspx
- https://www.prnewswire.com/news-releases/genomics-testing-companies-and-laboratories-combine-efforts-to-establish-the-cardiogenomic-testing-alliance-301507947.html
- https://www.mmm-online.com/home/channel/campaigns/23andme-morehouse-partner-on-sickle-cell-awareness-effort/
- https://23andme.gcs-web.com/news-releases/news-release-details/morehouse-school-medicine-sickle-cell-foundation-georgia-and
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Here’s a summary of other key strategic diagnostic deals announced in late March through April 2023:
Strategic Alliances, Partnerships, & Collaborations
| Partner 1 | Partner(s) 2+ | Deal Summary |
|---|---|---|
| Oxford Nanopore Technologies | BioMérieux | · Objective: Develop new tests for infectious diseases · Dynamic: Initial efforts to focus on: i.) an in vitro diagnostic (IVD) test to determine antibiotic-resistant tuberculosis, ii.) an assay to identify pathogens in normally sterile clinical samples, and iii.) validating Oxford Nanopore’s sequencing platform with BioMérieux’s EPISEQ® CS rapid infection outbreak monitoring in patient-care settings |
| Agilent Technologies | PathAI | · Objective: Help develop new companion diagnostics that are powered by AI and digital pathology · Dynamic: Agilent to distribute PathAI’s AISight™ and AISight DX+ platforms, as well as its AIM PD-L1 NSCLC algorithm globally · Agilent gets right to commercialize algorithms later launched by PathAI |
| Bio-Techne | Lunaphore | · Objective: Develop automated spatial omics workflow for highly multiplexed same-slide detection of protein and RNA · Dynamic: Workflow to combine Bio-Techne’s RNAscope™ in situ hybridization technology with Lunaphore’s COMET™ spatial biology platform |
| Foundation Medicine | Bristol Myers Squibb (BMS) | · Objective: Develop companion diagnostic for BMS’ investigational tyrosine kinase inhibitor repotrectinib · Dynamic: Expansion of existing collaboration to include Phase 1/2 trial called TRIDENT-1 for patients with TKI-naive or TKI-pretreated ROS1+ advanced non-small cell lung cancer (NSCLC) and NTRK+ advanced solid tumors |
| Roche | Eli Lilly | · Objective: Support development of Roche’s Elecsys® Amyloid Plasma Panel (EAPP) blood test for early Alzheimer’s disease diagnosis · Dynamic: EAPP test, which measures phosphorylated tau 181 (p-tau181) protein and apolipoprotein E4 in plasma to determine if a person is at high risk of Alzheimer’s, got Breakthrough Device designation in December 2022 |
| Avalon GloboCare | Qi Diagnostics | · Objective: Codevelop breathalyzer device for screening and early lung cancer detection · Dynamic: Firms to have joint ownership of intellectual property generated in breathalyzer product |
| Alpenglow Biosciences | Mayo Clinic | · Objective: Leverage Alpenglow’s 3D spatial biology platform to advance clinical diagnostics and drug development · Dynamic: Alpenglow to integrate its platform with multiomics approaches, including multiplex immunofluorescence and single-cell sequencing to predict therapy response and patient prognosis |
| Myriad Genetics | SimonMed | · Objective: Jointly launch hereditary cancer assessment program · Dynamic: Program to combine diagnostic imaging, patient education, and genetic risk assessment through Myriad’s MyRisk® and RiskScore® tools |
| Canopy Biosciences (subsidiary of Bruker) | Enable Medicine | · Objective: Use Enable’s spatial omics data pipeline for analysis of spatial proteomic imaging data produced on Canopy’s CellScape™ system · Dynamic: CellScape™ users to get access to Enable’s spatial analysis tools including for cluster analysis, neighborhood analysis, advanced data visualization, cloud-based computing, sharing, and data storage |
| Adaptive Biotechnologies | Takeda | · Objective: Use Adaptive’s clonoSEQ® assay for evaluating minimal residual disease (MRD) to develop and commercialize Takeda’s treatments for lymphoid malignancies · Dynamic: Use MRD status measured via clonoSEQ® assay as an endpoint in clinical trials to assess response to Takeda’s investigational medicines in patients with lymphoid malignancies · Adaptive to receive upfront payment and be eligible for future milestone payments |
| 23andMe | Morehouse School of Medicine + Sickle Cell Foundation of Georgia | · Objective: Launch awareness program for genetic carriers of sickle cell disease · Dynamic: 23andMe will provide free Health+Ancestry DNA testing kits to Morehouse students, faculty, and staff, with the Sickle Cell Foundation to offer counseling for those who participate |
| Mission Bio | Fulgent Genetics | · Objective: Expand accessibility of single-cell multiomics for drug development and clinical research · Dynamic: Fulgent to offer single-cell multiomics on its Tapestri Platform and evaluate Tapestri for applications in clinical development to streamline drug development and approval process |
| Illumina | Henry Ford Health | · Objective: Study impact of whole genome sequencing (WGS) in cardiovascular disease · Dynamic: Henry Ford’s Lisa and Christopher Jeffries Center for Precision Medicine and Center for Individualized and Genomic Medicine Research in Detroit to conduct clinical studies to investigate use of next-generation sequencing (NGS) tests, including WGS, in cardiac care · Partners to also launch 1,500-patient study (called CardioSeq) using an Illumina WGS-based test to create a “comprehensive cardiovascular genomic profile” |
| Guardant Health | Parker Institute for Cancer Immunotherapy (PICI) | · Objective: Study correlation between molecular cancer biomarkers and patient response to immunotherapy treatment across 14 types of cancer · Dynamic: Guardant to analyze patient blood samples from PICI’s RADIOHEAD (Resistance Drivers for Immuno-Oncology Patients Interrogated by Harmonized Molecular Datasets) prospective study in cohort of 1,200 individuals receiving standard-of-care immune checkpoint inhibitor treatment in community hospitals |
| Karius | eGenesis | · Objective: Develop infectious disease tests for xenotransplantation, from porcine to primates at first and, eventually, to humans · Dynamic: Karius to expand its microbial cell-free DNA detection platform for surveillance and diagnosis of potential infection in porcine organ donor and recipient before and after transplant |
| Angle | BioView | · Objective: Develop a liquid biopsy HER2 assay · Dynamic: Use Angle’s Parsortix® cell isolation technology and BioView’s automated microscopy systems and software to develop HER2 assay coupling immunofluorescence detection of the HER2 protein with FISH-based assessment of HER2/neu gene amplification |
| ReadyGo Diagnostics | Gemina Laboratories | · Objective: Develop rapid saliva-based test for Mycobacterium tuberculosis (MTB) · Dynamic: ReadyGo to develop, optimize, and validate MTB assay that Gemina Labs can run on the ReadyGo™ Geo platform |
| Ultima Genomics | Genome Insight | · Objective: Develop affordable WGS testing for cancer patients · Dynamic: Genome Insight to join the early-access program for Ultima’s UG 100 high-throughput sequencing platform and use Ultima’s sequencing technology to optimize its whole-genome bioinformatics algorithm for cancer analysis |
| Ginkgo Bioworks | Solvay | · Objective: Develop new sustainable biopolymers · Dynamic: Belgian firm Solvay to also acquire a lab in Cambridge, MA, that Gingko acquired from Zymergen as part of a July 2022 $300 million deal |
| Biocartis | Apis Assay Technologies | · Objective: Develop and commercialize Apis’ Breast Cancer Subtyping assay on Biocartis’ Idylla™ platform · Dynamic: Apis to spearhead development of test on the molecular diagnostics platform with Biocartis to spearhead commercialization via its Idylla™ network |
| MUJN Diagnostics (subsidiary of PanGenomic Health) | Hemex Health | · Objective: Develop point-of-care diagnostics for use with alternative brain health therapies · Dynamic: Master services agreement with MUJN to develop biomarker panels tracking patient response to alternative brain and mental health treatments · Hemex to adapt its portable, point-of-care Gazelle® instrument to run the cartridge-based tests |
| Stilla Technologies | Atila BioSystems | · Objective: Codevelop digital PCR kits for cancer liquid biopsy applications · Dynamic: Jointly market Atila’s digital PCR kits and assays produced for use on Stilla’s 6-color naica® system to create research-use-only kits for detecting circulating tumor DNA from liquid biopsy samples from cancer patients |
| SOPHiA GENETICS | Acutis Diagnostics | · Objective: Incorporate SOPHiA DDM™ analytics platform into new genomic assay to support clinical research and therapeutic development for hereditary cancers · Dynamic: Combine SOPHiA’s DDM™ for Hereditary Cancers Solution with Acutis’ lab analysis technologies to create NGS test to screen patients for eligibility in clinical trials |
| Factorial Biotechnologies | Watchmaker Genomics | · Objective: Further develop intracellular sequencing library preparation technology · Dynamic: Watchmaker to provide highly optimized and robust enzymes for Factorial’s library prep technology |
| OraSure Technologies | nRichDX | · Objective: Validate and co-promote firm’s respective research-use technologies to analyze cell-free DNA from urine · Dynamic: Combine the Colli-Pee® first-void urine collection and preservation device from OraSure subsidiary Novosanis and nRichDX Revolution sample prep system for cfDNA extraction |
| Onconova Therapeutics | Pangea Biomed | · Objective: Identify biomarkers to evaluate response to Onconova’s cancer drug candidate rigosertib · Dynamic: Use Pangea’s ENLIGHT AI platform to search for biomarkers related to inhibition of the PLK1 pathway and generate additional genetic interaction maps around other pathways targeted by rigosertib · Onconova to retain all rights to rigosertib and own intellectual property resulting from the collaboration |
| Invitae | Deerfield Management | · Objective: Identify new rare disease drug targets · Dynamic: Study data from over 3.6 million genetic tests delivered by Invitae |
| Massive Bio | NeoGenomics | · Objective: Improve identification and enrollment of cancer patients eligible for clinical trials for new oncology drugs · Dynamic: NeoGenomics to screen and identify patients with biomarkers that might qualify them for clinical trials · Massive Bio to then assist treating physicians in obtaining patient consent and provide additional testing to support enrollment process |
Distribution, Sales, & Marketing Agreements
| Product Owner | Distributor | Deal Summary |
|---|---|---|
| Devyser Diagnostics | Thermo Fisher Scientific | · Products: Devyser’s post-transplant NGS tests · Territories: North America and Europe · Exclusive |
| OpGen | Thermo Fisher Scientific | · Products: OpGen’s Unyvero A50 system and IVD tests · Territories: US · Nonexclusive |
| Molecular Loop Biosciences | D-MARK Biosciences | · Products: Molecular Loop’s LoopCap technology · Territories: Canada · Exclusive |
| Cerca Biotech | Sysmex Europe | · Products: Cerca’s RT-qPCR MammaTyper® assay to identify breast cancer subtypes · Territory: 13 countries in Europe |
| ABL Diagnostics | Roche Diagnostics | · Products: ABL’s DeepChek® genotyping assays and other products · Territory: South Africa · Exclusive |
| Acumen Diagnostics of Singapore | Provista Diagnostics (subsidiary of Todos Medical) | · Products: Acumen’s AcuSept® sepsis test · Territory: US · Todos gets rights to commercialize AcuSept as laboratory developed test in US |
Licenses
| Licensor | Licensee | Deal Summary |
|---|---|---|
| Beth Israel Deaconess Medical Center | CND Life Sciences | CND gets access to technologies for use in developing its Syn-One Test™ skin-based neurodegenerative disease test |
Government Contracts
| Contractor | Govt. Agency | Contract Summary |
|---|---|---|
| Aptitude Medical Systems | HHS’ Biomedical Advanced Research and Development Authority (BARDA) | Up to $53.7 million contract to develop and validate rapid, at-home molecular diagnostic assays for COVID-19 and influenza using Aptitude’s Metrix™ real-time loop-mediated isothermal amplification (RT-LAMP) testing platform |
| RAIsonance | HHS’ Biomedical Advanced Research and Development Authority (BARDA) | Just over $749,000 contract to develop AI-enabled device that uses an individual’s cough vocalization to diagnose illness within two minutes. |
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