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Roche & Quest Establish Toeholds in Emerging Alzheimer’s Blood Testing Market

by | Nov 29, 2023 | Deals-lir, Essential, Lab Industry Advisor

While Roche has an early lead, Quest recently made key moves to improve its position in the AD patient-initiated blood testing market.

The aging population and advances in biomarker technology have created a dynamic new market for blood-based testing for Alzheimer’s disease (AD). Once the domain of academic researchers and small life sciences companies, AD blood testing has become a magnet for diagnostic company investment, including power players Roche and Quest Diagnostics. “Companies are looking at the Alzheimer’s opportunity as potentially the next big thing in precision medicine,” says Kristen Amanti, a partner with Newtown, Massachusetts-based healthcare strategy consulting firm Health Advances, who advises companies in the precision medicine space. While Roche has staked out an early lead, Quest has recently made significant moves to improve its position in the AD patient-initiated blood testing market.

New biomarkers pave way for Alzheimer’s blood testing

AD-related dementia affects an estimated 6 million people in the US and 55 million people worldwide. As the population ages, US cases are expected to more than double by 2050.1 The easiest way to spot AD is via identification of impaired thinking. But because impaired cognitive ability in AD only appears after significant damage to the brain, by then, it’s frequently too late to provide effective treatment. This makes early detection crucial.

Historically, such early detection has relied on the use of positron emission tomography (PET) scans to identify the abnormally large amounts of amyloid proteins in the brain that AD patients generate.2 These plaque buildups interfere with neuron function. But PET testing is expensive and limited in both sensitivity and specificity.3 While cerebrospinal fluid (CSF) testing is an alternative, Amanti says that its invasive nature limits its utility, especially with an older population.2

But new sample types and biomarkers have emerged. Recent research suggests that elevated levels of certain beta amyloids and tau proteins in the blood are an accurate indicator of early onset and progression of AD. These tests can also be performed on a blood sample in a physician’s office.4 At the same time, recent FDA approvals of new drugs for treatment of early AD—Aduhelm (aducanumab) from Biogen and Leqembi (lecanemab) from Eisai—have given physicians more reason to perform such tests.

The new Alzheimer’s blood testing market

In less than two years, a new US market for AD blood testing has emerged. The first tests targeted two established and fairly well-known biomarkers in plasma: the ratio between beta amyloids β1-42 and β1-40 and the presence of high concentrations of certain phosphorylated tau (p-tau) proteins.

Washington University in St. Louis spinoff C2N Diagnostics received FDA Breakthrough Device Designation for its PrecivityAD assay in January 2019. The C2N test uses mass spectrometry to measure Aβ 42/40 ratio in combination with patients’ age to identify brain amyloid pathology associated with AD.5

In July 2022, the FDA granted Breakthrough Device Designation to Roche’s Elecsys Amyloid Plasma Panel measuring the amount of p-tau 181 and apolipoprotein e4 (ApoE4) in blood. According to Roche’s press release announcing the designation, the company is the first in vitro diagnostics manufacturer to gain such FDA designation for a blood-based biomarker test for AD.6

The agency has also granted Breakthrough Device Designation to a few other such Alzheimer’s products since 2019 but has not yet granted full clearance to blood-based AD tests. Other blood-based options from key players in the AD blood testing space have also been recently launched, though they have not been cleared or approved by the FDA:

Blood-Based AD Tests on the US Market

ManufacturerProduct NameFDA Clearance Status
QuanterixSimoa® p-Tau-181Breakthrough Device Designation
RocheElecsys® Amyloid Plasma PanelBreakthrough Device Designation
C2N DiagnosticsPrecivityAD®Breakthrough Device Designation
C2N DiagnosticsPrecivityAD2Not FDA-cleared or approved
DiademAlzoSure® PredictBreakthrough Device Designation
Quest DiagnosticsAD-Detect Test for Alzheimer’s DiseaseNot FDA-cleared or approved
LabcorpATN ProfileNot FDA-cleared or approved
Source: Company press releases

Amanti believes that the market for tests targeting the original p-tau and beta amyloid ratio biomarkers will likely develop the fastest. Roche has gotten off to a particularly strong start by concentrating on tests that run on the firm’s well-established Elecsys platform. The fact that these biomarkers are the most well established and have the most supporting evidence gives the Roche panel an edge in attracting physician orders for AD blood tests.

However, smaller companies and specialty labs, including C2N Diagnostics, have also won FDA Breakthrough Device Designation for innovative laboratory-developed tests (LDTs) for AD. In January 2022, Italian firm Diadem gained the designation for its AlzoSure Predict AD test, which was developed with funding from the National Institutes of Health and uses a variant of the protein p53 to assess AD.7

Meanwhile, Quest has opened a new dimension of the market by launching what the firm describes as the first direct-to-consumer (DTC) blood test for AD, the Quest AD-Detect test, which measures the ratio of Aβ42 and Aβ40 using the same technology as the firm’s clinical AD-Detect Amyloid Beta 42/40 Ratio test launched for physician ordering in early 2022. Priced at $399 USD, customers can purchase AD-Detect without a physician’s order through Quest’s consumer-initiated testing platform, questhealth.com. Tests are performed at Quest labs, then purchasers get to discuss their test results with an independent physician network that provides clinical oversight of test ordering and results delivery, according to the Quest press release announcing the product launch.8

Although marketed as a DTC product, Amanti says AD-Detect is more akin to a patient-initiated product similar to genetic cancer screening tests like MyRisk by Myriad Genetics. “Patients order the test themselves, and then a physician in the lab’s telemedicine network will review the order to ensure that it is medically necessary and approve or deny the order.” Amanti also says that Quest’s extensive lab network makes it an attractive partner for smaller companies developing novel AD diagnostics. Accordingly, on October 25, Quest inked a licensing deal with Diadem, giving it exclusive US rights to AlzoSure Predict. The agreement gives Quest the right to develop, validate, and market the test in the US.9

The wild, wild West of AD blood tests

The market for Alzheimer’s blood testing has arrived, and with it come concerns. It’s the “wild, wild West,” says Amanti, citing the lack of clinical guidelines on the proper use of these tests. There are also questions about test accuracy. For example, experts have expressed concerns about the accuracy of the new Quest AD-Detect test.10

It’s also unclear whether insurers will reimburse for these tests and under what conditions. All of this leaves neurologists with difficult choices to make when ordering AD blood tests for their patients, assuming a patient who is thinking of using such tests, but hasn’t been diagnosed with AD and is not showing symptoms, even consults a neurologist. Even so, the scramble for a position in the Alzheimer’s blood testing marketing is well underway.

 

References:

    1. https://www.alz.org/alzheimers-dementia/facts-figures

    1. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-new-test-improve-diagnosis-alzheimers-disease

    1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856004/

    1. https://www.alz.org/alzheimers-dementia/diagnosis/medical_tests

    1. https://c2n.com/news-releases/2019/01/29/2019-1-24-c2n-diagnostics-receives-breakthrough-device-designation-from-us-fda-for-blood-test-to-screen-for-alzheimers-disease-risk

    1. https://diagnostics.roche.com/us/en/news-listing/2022/elecsys-amyloid-plasma-panel-fda-breakthrough-device-designation-alzheimers.html

    1. https://www.prnewswire.com/news-releases/fda-grants-breakthrough-device-designation-to-diadems-alzosure-predict-prognostic-blood-test-for-the-early-prediction-of-alzheimers-disease-301462419.html

    1. https://www.prnewswire.com/news-releases/quest-introduces-first-to-market-consumer-initiated-blood-test-for-alzheimers-disease-risk-assessment-on-questhealthcom-301888653.html

    1. https://newsroom.questdiagnostics.com/2023-10-25-Diadem-SpA-Announces-Exclusive-U-S-Licensing-Agreement-with-Quest-Diagnostics-for-Its-AlzoSure-R-Predict-Alzheimers-Disease-Prognostic-Technology

    1. https://www.medpagetoday.com/neurology/alzheimersdisease/105784

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Here’s a summary of other key strategic diagnostic deals announced in the period from late October through mid-November 2023:

Mergers, Acquisitions, and Asset Sales

Acquiring CompanyTarget(s) Deal Summary
Thermo Fisher ScientificOlink• Price: Approximately $3.1 billion cash for all outstanding common shares at $26.00 per share
• Status: Commencement of previously announced tender offer expected to close by mid-2024
• Thermo acquires Olink’s Proximity Extension Assay (PEA) technology for high-throughput protein analysis, with Olink to become part of its Life Sciences Solutions segment with expected growth in “mid-teens organically”
UnilabsAtalmedial• Price: Undisclosed
• Status: Closed
• Acquisition of laboratory diagnostics and thrombosis care provider bolsters Unilab’s network of specialized diagnostic labs in the Netherlands
Oxford Nanopore TechnologiesNorthern Nanopore Instruments• Price: Undisclosed
• Status: Closed
• Acquisition of Canadian biotech startup that has developed a solid-state nanopore fabrication technology used for research expands Oxford Nanopore’s longer-term technology pipeline by enhancing its solid-state nanopore expertise and patent portfolio
Xlife Sciences4D Lifetec• Price: CHF 23.3 million ($25.9 million) for 20% stake
• Status: Expected to close in November
• 4D Lifetec to gain access to artificial intelligence (AI)-based digital health software developed by Xlife for use with its 4D Lifetest early cancer detection technology
New Day DiagnosticsEpigenomics• Price: Undisclosed
• Status: Closed
Acquisition enables New Day Diagnostics to provide accessible diagnostic solutions via clinical trials, manufacturing, and eventual market entry
Clinical Microbiomics A/SCosmosID• Price: Undisclosed
• Status: Expected to close in Q1 2024
• Bioinformatics reporting firm merges with microbiome contract research services organization to form what the companies describe as the first microbiome service company with a global infrastructure of multiomics labs that meet good practice guidelines (GxP) standards

Strategic Alliances, Partnerships, and Collaborations

Partner 1Partner(s) 2+Deal Summary
QIAGENMyriad Genetics• Objective: Develop companion diagnostic tests for cancer
• Dynamic: Master collaboration agreement with Myriad to leverage its lab platform, assay development expertise, and commercial infrastructure for clinical sample testing and QIAGEN to provide expertise in sample preparation, PCR, digital PCR, next-generation sequencing (NGS), Digital Insights bioinformatics portfolio, product manufacturing capabilities, and global commercial channels
Beckman Coulter Life Sciences (Danaher subsidiary)Pillar Biosciences• Objective: Develop NGS-based tests for cancer
• Dynamic: Pillar Biosciences to develop series of tests for use on Beckman Coulter’s Biomek NGeniuS Next Generation Library Preparation System
Burning Rock DxBoehringer Ingelheim• Objective: Advance Boehringer Ingelheim’s clinical trial for MDM2-p53 antagonist, brigimadlin, and develop associated companion diagnostic for Chinese market
• Dynamic: Companion diagnostics master service agreement with Burning Rock to provide comprehensive support for trial, and develop and validate a companion diagnostic to identify patients who have the appropriate biomarker profile
Thermo Fisher ScientificBoehringer Ingelheim• Objective: Develop companion diagnostic tests to identify patients with non-small cell lung cancer (NSCLC) with specific mutations who may benefit from Boehringer Ingelheim’s new targeted therapies
• Dynamic: Create multiple companion diagnostic tests based on Thermo’s Oncomine Dx Express Test on the Ion Torrent Genexus Dx System, as well as its Oncomine Dx Target Test
Adaptive BiotechnologiesBeiGene• Objective: Develop and commercialize therapeutics for hematologic malignancies
•Dynamic: Multiyear agreement to use Adaptive’s NGS-based clonoSEQ® assay to assess minimal residual disease (MRD) across BeiGene’s pipeline of lymphoid malignancy treatments
• Adaptive to receive upfront payment of undisclosed size and perhaps future milestone payments upon achievement of regulatory milestones “in certain geographies”
Caris Life SciencesPramana• Objective: Digitize about 1.5 million pathology slide specimens per year for use with Caris’ AI-developed software to support treatment decisions and clinical trial recruitment
• Dynamic: Multiyear deal with Pramana to use its Spectral scanners and Intelligent Acquisition image recognition software to provide digital scans of pathology specimens for Caris’ digital pathology business
Caris Life SciencesModerna• Objective: Promote development of mRNA-based cancer therapeutics
• Dynamic: Multiyear partnership agreement gives Moderna access to Caris’ library of de-identified, multimodal data derived from whole-exome sequencing, whole-transcriptome sequencing, protein analyses, and claims data for designing clinical trials, discovering new biomarkers, and characterizing resistance mechanisms
DNAnexusFabric Genomics•Objective: Provide NGS data management for hospitals, clinical labs, and academic medical centers
• Dynamic: Integrate Fabric’s genomic analysis tools with the DNAnexus Precision Health Cloud to create workflow for interpreting genomic sequences, detecting clinically meaningful variants, and generating comprehensive patient reports for rare disease and cancer diagnostics
Oxford Nanopore TechnologiesFabric Genomics• Objective: Develop scalable software solution enabling end-to-end analysis of nanopore whole-genome sequencing data and clinical reporting of genomic data
• Dynamic: Create clinical reporting platform that integrates Oxford Nanopore’s EPI2ME software with Fabric’s software-as-a-service platform to be powered by Fabric GEM AI algorithm, with initial focus on use of nanopore sequencing to support rapid disease diagnostics in neonatal and pediatric intensive care units
Oxford Nanopore TechnologiesGenomics England• Objective: Advance research of undiagnosed rare disease cases
• Dynamic: Using nanopore sequencing, analyze up to 7,500 samples from participants of the 100,000 Genomes Project with genetic or suspected genetic disorders as part of a multiomic study led by Genomics England
Oxford Nanopore TechnologiesSaphetor• Objective: Enable tertiary analysis of nanopore sequencing data for variant interpretation and prioritization
• Dynamic: Integrate Oxford Nanopore’s EPI2ME research software with Saphetor’s VarSome Clinical platform to create an end-to-end workflow focusing on the analysis of long-read whole genome sequencing for rare and undiagnosed diseases, initially for clinical research
Guardant HealthFlatiron Health• Objective: Enable clinicians at over 800 cancer care locations in Flatiron’s network to order Guardant’s blood- and tissue-based tests for early- and advanced-stage cancer through Flatiron’s cloud-based platform
• Dynamic: Integrate Guardant’s genomic profiling tests into Flatiron’s OncoEMR® electronic medical record management platform
10x GenomicsBeckman Coulter Life Sciences• Objective: Develop automated single-cell assay workflows
• Dynamic: 10x to develop and validate dedicated Chromium single-cell consumables kits for use with Beckman Coulter’s Biomek i7 automated liquid handler
• Initial focus on high-throughput library preparation after a Chromium instrument run is complete, enabling automated library prep for labs processing dozens of single-cell samples at once
Foundation MedicineSequanta Technologies• Objective: Offer Foundation’s genomic profiling tests for research and oncology therapy development in China
•Dynamic: Expand current partnership with Foundation to conduct a technology transfer of its FoundationOne® CDx and FoundationOne® Liquid CDx tests for research and investigational uses and Sequanta to perform the tests and seek regulatory approvals in China
Foundation MedicineNatera• Objective: Launch jointly developed FoundationOne® Tracker personalized circulating tumor DNA (ctDNA) monitoring assay
• Dynamic: Tissue-informed ctDNA monitoring test now available to healthcare providers in US, which has secured Medicare coverage via contractor Palmetto GBA’s Molecular Diagnostics Program (MolDX) for monitoring of response to immune-checkpoint inhibitor therapy for qualifying Medicare beneficiaries with all solid tumors
GenialisCancer Research Horizons (CRH)• Objective: Validate Genialis’ core ResponderID therapy response prediction platform
• Dynamic: CRH to curate anonymized colorectal cancer datasets containing omics and clinical metadata from diverse patient populations
• Genialis to use datasets to improve and validate its machine learning-driven platform’s ability to identify biomarkers predictive of patient response to KRAS inhibitors, immunotherapies, and other targeted therapies
FujirebioSysmex• Objective: Develop new immunoassays
• Dynamic: Expansion of current arrangement in which Fujirebio has been developing dedicated reagents for Sysmex’s Automated Immunoassay System HISCL-Series through its subsidiaries, with firms to explore potential collaborations, including research and development, production, clinical development, and sales and marketing
RevvitySCIEX (Danaher subsidiary)• Objective: Improve accuracy of mass spectrometry-based disease screening in newborns
• Dynamic: Distribution agreement combining Revvity’s NeoBase 2 and NeoLSD MSMS reagent kits with SCIEX’s mass specs for newborn screening tests
Mainz BiomedLiquid Biosciences• Objective: Analyze results from Mainz’s clinical studies for its colorectal cancer test
• Dynamic: Mainz to use Liquid Biosciences’ AI analysis technology platform EMERGE to analyze results of its eAArly DETECT study—the US arm of its ColoFuture study—and its upcoming ReconAAsense trial for FDA premarket approval
• Mainz previously used EMERGE to analyze results of its ColoFuture study for its ColoAlert test
XtalPiCK Life Sciences• Objective: Develop miRNA-based postoperative molecular diagnostic models for prognostic risk prediction for cancer
• Dynamic: Combine AI-based algorithms from XtalPi with anonymized clinical and biomarker data from both cancer patients and healthy individuals contained in CK Life Sciences’ data repository to develop the models
OGT (part of Sysmex Group)Intelliseq• Objective: Develop NGS data analysis solutions
• Dynamic: Combine OGT’s SureSeq NGS portfolio with Intelliseq’s iFlow engine to create a sample-to-report NGS analysis workflow
Genome InsightShriners Children’s• Objective: Develop targeted treatment options for adolescent idiopathic scoliosis
• Dynamic: Genome Insight to analyze genomic data from 100 adolescent patients treated at Shriners Children’s via its whole genome sequencing analysis and interpretation platform
Complete Genomics
(US subsidiary of MGI Tech)
Basepair• Objective: Integrate Basepair’s cloud computing-based bioinformatics platform with Complete’s DNBSEQ sequencers for data analysis
• Dynamic: Enable Complete Genomics customers to access Basepair’s bioinformatics platform on Amazon Web Services
• Users to receive “preferential commercial terms” to run secondary analysis tools and pipelines for NGS and interactive visualization

Distribution, Sales, and Marketing Agreements

Product OwnerDistributorDeal Summary
KDx DiagnosticsLabForce• Products: KDx’s noninvasive URO17® Test for bladder cancer
• Territories: Switzerland
KDx DiagnosticsMCT Lifesciences• Products: KDx’s noninvasive URO17® Test for bladder cancer
• Territories: UK
GradientechAB Scientific• Products: Gradientech’s QuickMIC® antibiotic susceptibility testing system
• Territories: UK and Ireland
• Exclusive
GradientechIberlab• Products: Gradientech’s QuickMIC® antibiotic susceptibility testing system
• Territories: Portugal
• Exclusive
FibronosticsStone Diagnostics• Products: Fibronostics’ LIVERFASt AI-based liver disease test
• Territories: US
Cardio DiagnosticsAimil• Products: Cardio Diagnostics’ PrecisionCHD test for detection and personalized management of coronary heart disease
• Territories: India

Licenses

LicensorLicenseeDeal Summary
Johns Hopkins UniversityExagenExagen gets exclusive global license to develop novel patented biomarkers for therapeutic management of lupus nephritis
DiademQuest DiagnosticsQuest gets exclusive US rights to Diadem’s AlzoSure® Predict Alzheimer’s blood test with Quest to develop, validate, and market the assay as a laboratory-developed test in the US
Janssen Sciences Ireland (Johnson and Johnson subsidiary)QuanterixQuanterix gets nonexclusive global license to research-use-only Simoa phosphorylated-tau 217 immunoassay kits to develop blood-based assays for diagnosis and research of Alzheimer’s disease
ERS GenomicsCHUM Research Centre (CRCHUM) at the University of MontrealCHUM gets nonexclusive research rights to ERS Genomics’ CRISPR-Cas9 gene editing patent portfolio
ERS GenomicsSyngene InternationalSyngene gets nonexclusive research rights to ERS Genomics’ CRISPR-Cas9 gene editing patent portfolio
Roswell Park Cancer Center  Agilent TechnologiesAgilent licenses Roswell Park’s PanHeme blood-based NGS cancer assay for detecting gene alterations in order to commercialize the product

Government Contracts

ContractorGovt. AgencyContract Summary
Ginkgo BioworksUS Centers for Disease Control and Prevention’s Traveler-based Genomic Surveillance ProgramExpansion of previously announced contract originally worth $16 million to conduct, in partnership with XWELL, SARS-CoV-2 surveillance testing in US airports via addition of 30 more pathogens, including influenza A and B, respiratory syncytial virus, and antimicrobial resistance markers

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