Quest and Color Health Join CDC to Promote Equitable COVID-19 Testing

The COVID-19 pandemic has exposed the social barriers that keep Black, Latino, and other marginalized communities from accessing vital lab testing services. The US Centers for Disease Control and Prevention (CDC) has played a leading role in kicking through these barriers and promoting equitable access via the Increasing Community Access to Testing (ICATT) program, which provides free COVID-19 testing for high-risk populations in underserved communities across the nation. In July, ICATT took a major stride forward by enlisting two of the country’s leading COVID-19 PCR test providers: Quest Diagnostics and Color Health.

The ICATT Program

ICATT participants include over 15,000 testing sites in all 50 states, Washington DC, and Puerto Rico. ICATT centers provide testing for the uninsured, but also bills tests to Medicare, Medicaid, and private health insurers. The program selects testing sites based on the Rural-Urban Commuting Areas and Social Vulnerability indexes with the aim of maximizing access in areas of high social vulnerability.

ICATT partners schedule appointments, register patients for testing, collect patient specimens, process tests, and report test results to individuals and public health departments. Offered COVID-19 tests vary by site but include both PCR and rapid point-of-care assays, including at-home test kits.

Quest Joins ICATT

On July 7, one of the nation’s largest lab companies, Quest Diagnostics, joined the ICATT effort by agreeing to provide $0 out-of-pocket COVID-19 testing to uninsured individuals at roughly 1,200 of its 2,100 patient service centers. Those seeking free tests will have to fill out a screening questionnaire on the company’s QuestDirect service. Those who qualify will then be instructed to schedule an appointment at one of the 1,200 participating test centers. “Through this relationship with CDC, Quest will extend access to our COVID-19 diagnostic services in underserved communities, helping to close equity gaps in the nation's pandemic response,” Ruth Clements, Quest vice president and general manager of infectious disease and immunology, said in a statement.

ICATT Adds Color Health

The day after the Quest announcement, Color Health stated that it would also offer free COVID-19 PCR testing under the ICATT program. Most of the nearly 1,000 Color testing sites will be in public libraries and pharmacies located in rural areas. As per ICATT protocols, the emphasis will be on testing people at high risk of severe COVID-19 who are under- or uninsured. Many of the sites will be unmonitored, with free kits offered for individuals to pick up, perform nasal swabs themselves, and drop off samples.

This is hardly Color’s first effort to support community COVID-19 testing and public health ventures. Based in Burlingame, California, the firm has COVID-19 testing partnerships with San Francisco, the state of California, and the National Institutes of Health, among other institutions. It has also partnered with Thermo Fisher Scientific to provide COVID-19 testing to school districts nationwide.

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Here’s a summary of some of other key strategic diagnostic deals announced in July 2022:

Strategic Alliances, Partnerships, & Collaborations

Partner 1	Partner(s) 2+	Deal Summary
Beckman Coulter (Danaher subsidiary)	Scopio Labs	• Objective: Expand Scopio's digital blood smear platforms • Dynamic: Scopio’s next-generation peripheral blood smear platforms use full-field imaging and AI-supported decisions to eliminate manual microscopy
Beckman Coulter (Danaher subsidiary)	Massachusetts General Hospital	• Objective: Validate a screening tool for detecting severe infections in children in emergency departments • Dynamic: Multicenter trial to study use of Beckman's monocyte distribution width (MDW) hematology biomarker assay in rapid identification of children presenting with early signs of severe illness from infection • Unspecified funding to be provided by HHS’ Biomedical Advanced Research and Development Authority (BARDA)
Cepheid (Danaher subsidiary)	BioGX	• Objective: Develop a monkeypox assay on the GeneXpert system • Dynamic: Assay to be delivered as part of Cepheid's FleXible Cartridge program for GeneXpert
Burning Rock Biotech	MGI Tech	• Objective: Develop precision oncology services and products • Dynamic: Burning Rock to leverage MGI's DNBSeq high-throughput sequencers to provide commercial services and develop in vitro diagnostic products with MGI to offer technical support and services
Grail (Illumina subsidiary)	Mercy	• Objective: Make Grail’s Galleri early cancer detection blood test available to patients of Mercy’s centers in southern and southwestern US • Dynamic: Customers will have to pay for test out of pocket since Galleri isn’t covered by insurance, but Mercy will offer financial help to those who can’t afford the test
Twist Bioscience	DNAnexus	• Objective: Help their respective customers develop NGS-based diagnostics • Dynamic: Enable Twist customers to use the DNAnexus platform with Twist’s NGS Methylation Detection System and unique molecular identifier adapters to simplify data analysis after sequencing
Nucleai	Sirona Dx	• Objective: Discover novel biomarkers in solid tumors • Dynamic: Combine Nucleai’s AI-based spatial analytics platform with Sirona Dx’s multiplex assay development know-how to identify novel spatial signatures in high-plex assays that predict response to therapy and guide treatment decisions
Invitae	Worldwide Clinical Trials	• Objective: Boost patient enrollment in rare disease clinical studies • Dynamic: Worldwide Clinical Trials to use Invitae’s Explorer real-world data platform to access aggregated insights on the prevalence, incidence, demographics, geography, epidemiology, and genetics of rare diseases, with data to be used to identify patients eligible for trials and pinpoint where to open sites for studies investigating new treatments for rare diseases
BostonGene	Memorial Sloan Kettering Cancer Center	• Objective: Provide molecular lab and computational analysis services to support cancer precision medicine research initiatives • Dynamic: BostonGene to provide advanced analytics of NGS data from MSK-IMPACT sequencing test for solid tumors to identify new biomarkers in MSK's clinical and preclinical research programs • BostonGene to also perform bioinformatic analyses to identify targetable molecular alterations, analyze gene expression and gene signatures
Ultima Genomics	Regeneron Pharmaceuticals	• Objective: Develop and test Ultima's second-generation sequencing platform • Dynamic: Regeneron, which is already part of the early-access program for Ultima's UG100 sequencer, to further invest by purchasing undisclosed number of Ultima shares
Quotient Limited	Infynity Biomarkers	• Objective: Develop infectious disease tests for Quotient's MosaiQ platform • Dynamic: Infynity to help with research and design of tests to expand Quotient's MosaiQ Serology Disease Screening menu and reduce the time and costs of assay development and commercialization
IdentifySensors Biologics	Jabil	• Objective: Develop manufacturing processes for portable digital diagnostic device • Dynamic: Jabil to help manufacture IdentifySensors' Check4 devices, which contain a reusable electronic reader and single-use test cartridge for simultaneously detecting up to 4 infections from one sample
Saphetor	PTC Therapeutics	• Objective: Boost awareness of clinical programs in rare diseases • Dynamic: Leverage Saphetor’s VarSome genome interpretation platform to accelerate research collaboration
BillionToOne	University of California, San Diego	• Objective: Evaluate BilllionToOne’s newly launched Northstar Select and Northstar Response liquid biopsy assays, in late-stage non-small cell lung cancer • Dynamic: BillionToOne has completed internal validation of assays in 6 cancer types overall • Commercial launch of assays, now available for research use, expected in early 2023
Caris Life Sciences	Epic	• Objective: Integrate Caris' molecular testing portfolio with Epic's Orders and Results Anywhere (ORA) network • Dynamic: Enhancement of existing partnership with Caris to make its entire suite of molecular profile services available, including whole exome and whole transcriptome sequencing for both tissue and blood samples
BioMérieux	Boehringer Ingelheim + Evotec	• Objective: Develop and commercialize new antimicrobials and diagnostics • Dynamic: Form new joint venture (JV) called Aurobac Therapeutics, with €40 million ($40.8 million) in funding, to fight antimicrobial resistance • JV to be headquartered in Lyon, France, with Boehringer Ingelheim to invest €30 million to establish the company, and Evotec and BioMérieux to each invest €5 million
Boehringer Ingelheim	BiomX	• Objective: Identify biomarkers for inflammatory bowel disease • Dynamic: BiomX to use its XMarker microbiome-based discovery platform to identify signatures associated with an IBD-related pathogenic bacterium for use in identifying patients who would benefit from potential microbiome-targeted therapies
Guardant Health	Adicon	• Objective: Offer Guardant's tissue and blood-based genomic cancer assays to biopharma companies conducting clinical trials in China • Dynamic: Strategic partnership under which Adicon licenses assays from Guardant’s liquid biopsy assays Guardant360 and GuardantOmni, the Guardant360 TissueNext, and the Guardant Reveal minimal residual disease test
MultiOmic Health	Mesh Bio	• Objective: Leverage AI to improve diagnostics and advance drug discovery in chronic metabolic disease • Dynamic: Conduct an observational study in patient populations in Asia to look at risk for complications such as chronic kidney disease, with Mesh Bio to recruit patients and MultiOmic to generate genomic, proteomic, and metabolomic data and combine it with existing datasets from both companies to create a multiomics dataset for AI-based computational biology models for analysis
Akoya Biosciences	Acrivon Therapeutics	• Objective: Codevelop, validate, and commercialize companion diagnostic test for Acrivon's targeted DNA damage response inhibitor, ACR-368 • Dynamic: OncoSignature test, developed by Acrivon, to be used to identify cancer patients most likely to respond to treatment with ACR-368, a targeted DNA damage response inhibitor therapy
Almac Diagnostic Services	AstraZeneca	• Objective: Develop and commercialize companion diagnostics • Dynamic: Almac to develop and validate companion diagnostic assays for use in selecting patients for AstraZeneca's clinical studies in kidney disease, nonalcoholic steatohepatitis, and respiratory disease • Almac to obtain regulatory approval for assays in specific markets in parallel with AstraZeneca's therapeutics
Biocartis	AstraZeneca	• Objective: Develop molecular test to identify patients with non-small cell lung cancer most likely to respond to AstraZeneca's Tagrisso (osimertinib) treatment • Dynamic: Biocartis plans to validate test, called Idylla EGFR CDx Assay, in formalin-fixed, paraffin-embedded tissue samples, and cytology samples such as fine needle aspirates
PrognomiQ	Maccabi Health Services	• Objective: Discover and develop cancer biomarkers • Dynamic: Use PrognomiQ's multiomic biomarker discovery platform to analyze samples from Maccabi's sample biobank to identify potential markers for early detection of colorectal, lung, pancreatic, and breast cancer

Distribution, Sales, & Marketing Agreements

Product Owner	Distributor	Deal Summary
Nanomix	Biotron	• Products: Nanomix’s eLab point-of-care immunoassay and chemistry diagnostic system and related sepsis panel • Territory: Israel
Precipio	Fisher Healthcare (part of Thermo Fisher Scientific)	• Products: Precipio's HemeScreen assays for detecting hematologic malignancies • Territory: US • Deal relieves Precipio of need to build its own in-house sales force
Inspira Technologies	Glo-Med Networks	• Products: Inspira’s HYLA blood sensor device and disposable units • Territory: New Jersey, South Carolina, North Carolina, Florida, Texas, New York • Exclusive
CardiNor	IBL-America	• Products: CardiNor Secretoneurin ELISA test • Territory: US • Exclusive
Gradientech	Biomedica	• Products: Gradientech QuickMIC system • Territory: Austria, Switzerland, Central Eastern Europe • Exclusive
Diagnostic Biosystems	Leader Life Sciences	• Products: Diagnostic Biosystem's immunohistochemical applications, and primary antibodies and staining solutions • Territory: United Arab Emirates and adjacent markets

Licenses

Licensor	Licensee	Deal Summary
Medical College of Wisconsin (MCW)	GenDx	GenDx gets worldwide license to MCW’s patented method to detect donor-specific cell-free DNA in pediatric patients that have undergone a heart transplant
ERS Genomics	Cytosurge	Swiss firm Cytosurge gets non-exclusive license to ERS Genomics’ CRISPR-Cas9 patent portfolio
QIMR Berghofer	Proteomics International Laboratories (PIL)	PIL gets exclusive worldwide license to use QIMR’s esophageal cancer blood biomarkers to develop and commercialize a blood-based early detection test for esophageal cancer

Government Contracts

Contractor	Govt. Agency	Contract Summary
Quest Diagnostics	US Centers for Disease Control and Prevention (CDC)	CDC tabs Quest to provide $0 out-of-pocket COVID-19 testing to qualifying uninsured individuals at roughly 1,200 of the company's 2,100 patient service centers under the CDC’s Increasing Community Access to Testing (ICATT) for COVID-19 program