New Day Diagnostics
New Day Diagnostics is a Knoxville-based clinical laboratory that develops and commercializes blood-based liquid biopsy diagnostics, led by its ColoHealth colorectal cancer screening test, and offers contract research services to pharmaceutical and biotech sponsors.
- Company typePrivate
- Founded2005
- HeadquartersBoca Raton, United States
- Headcount1–10
- GTM typeB2B and B2C
- OfferingServices
What New Day Diagnostics does
New Day Diagnostics, LLC is a Knoxville, Tennessee-based clinical laboratory and diagnostic development company specializing in blood-based liquid biopsy tests for early cancer detection, with a flagship focus on colorectal cancer screening. The company markets ColoHealth, a non-invasive blood test that uses Real-Time PCR detection of the methylated Septin 9 (mSEPT9) biomarker and reports 99.7% negative predictive value in clinical validation. ColoHealth is sold direct-to-consumer through colohealthy.com at a $299 fixed self-pay price and is also available to physicians via a dedicated portal with consolidated monthly billing. The company is building a broader diagnostic pipeline that includes the in-development ColoPlex Plus multi-target assay, a prostate cancer assay, the SPINEstat ankylosing spondylitis test developed with Augurex, and tests for celiac disease, H. pylori, respiratory multiplex, and hepatocellular carcinoma in collaboration with Hepion Pharmaceuticals.
The company was formed through the 2023 merger of New Day Diagnostics and EDP Biotech Corporation, followed by the September 2023 asset acquisition of Epigenomics AG, which transferred 450 patents and the Epi proColon technology into the combined entity. New Day operates a CLIA-certified high-complexity laboratory (CLIA #44D2184836) and maintains ISO 13485:2016 certification for diagnostic device design, and it monetizes laboratory capacity beyond its own products through New Day Bioresearch, a contract research organization offering assay design, analytical validation, clinical trial support, and regulatory strategy to pharmaceutical and biotech sponsors. Distribution combines direct-to-consumer e-commerce, a physician ordering portal, a Middle East distribution partnership with SehaMed Global, and a research collaboration with Daisy Genomics and the University of Tennessee aimed at next-generation epigenetic sequencing. Leadership is led by CEO Eric Mayer (since 2015) and Executive Chairman Navroze Mehta, supported by a board with prior operating experience at Welch Allyn, NextGen Healthcare, Jewelry Television, and other companies.
New Day Diagnostics firmographics
Firmographics- Name
- New Day Diagnostics
- Legal name
- New Day Diagnostics, LLC
- Website
- https://newdaydiagnostics.com
- Company type
- Private
- Founded year
- 2005
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- New Day Diagnostics is a Knoxville-based clinical laboratory that develops and commercializes blood-based liquid biopsy diagnostics, led by its ColoHealth colorectal cancer screening test, and offers contract research services to pharmaceutical and biotech sponsors.
- Ownership category
- akta.pro rank
New Day Diagnostics industry classification
Industry- Product category
- Molecular Cancer Diagnostics
- NAICS
- Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG)
- akta.pro secondary industries
- Translational Medicine & Biomarkers (HLAIALAF), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)
Keywords
Where New Day Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Boca Raton
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
New Day Diagnostics business model
Business model- GTM type
- B2B and B2C
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure
Revenue model
- ColoHealth Direct Sales: Direct-to-consumer sales of blood-based colorectal cancer screening test at $299 fixed self-pay price, enabling patients to order online without insurance hassles.
- Professional Laboratory Services: Laboratory testing services billed professionally to healthcare providers and clinics through the physician portal, including consolidated monthly invoicing for practice clients.
- CRO Services (New Day Bioresearch): Contract Research Organization services including assay design, analytical validation, clinical trial management, and regulatory compliance support for pharmaceutical and biotech sponsors.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Pay-as-you-go | ColoHealth Direct - Self-Pay |
| Transaction based/ take rate | Monthly | ColoHealth for Physicians |
Go-to-market motion3 records
Distribution channels4 records
Marketing channels3 records
New Day Diagnostics product offering
Product offeringCore offering
New Day Diagnostics develops and commercializes blood-based molecular diagnostic tests, with its flagship ColoHealth product providing non-invasive colorectal cancer screening via Real-Time PCR detection of the methylated Septin 9 (mSEPT9) biomarker from a routine blood draw. The company also operates New Day Bioresearch, a Contract Research Organization offering end-to-end assay design, analytical validation, clinical trial management, and regulatory strategy services for pharmaceutical and biotech sponsors.
Product overview
New Day Diagnostics offers a portfolio of blood-based diagnostic products centered on its flagship ColoHealth test for colorectal cancer screening, complemented by a vertically integrated CRO services division (New Day Bioresearch) that provides end-to-end partnership for assay development, clinical trial management, and regulatory strategy. The commercial product lineup is led by ColoHealth (FDA-approved science, 99.7% NPV, mSEPT9 biomarker), which is available as direct-to-consumer (ColoHealth Direct) and physician-orderable (ColoHealth for Physicians) offerings. The development pipeline includes ColoPlex Plus (next-generation multi-target CRC assay), a Prostate Cancer Assay (research/discovery stage), and tests for Celiac Disease, H. pylori, and Respiratory Multiplex (COVID-Flu-RSV) developed under partnership agreements. New Day Bioresearch CRO services support external pharmaceutical and biotech sponsors across oncology, infectious diseases, gastrointestinal disorders, and women's health.
Differentiator
Problem solved
Functional benefit
Brands
- ColoHealth: Blood-based colorectal cancer screening test with 99.7% NPV. A non-invasive alternative to colonoscopy for average-risk adults aged 50+.
- New Day Bioresearch
- ColoPlex
- ColoPlex Plus
Quantifiable outcome
- 99.7% Negative Predictive Value (NPV) in clinical validation studies
- +2 more outcomes
Companies that use New Day Diagnostics
Customer profileNamed customers2 records
Segments4 records
Ideal customer profiles4 records
New Day Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability4 records
Feature4 records
New Day Diagnostics partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered core.
- Daisy Genomics Inc.coreStrategic research collaboration to advance next-generation epigenetic sequencing and liquid biopsy tools for early colorectal cancer detection. Combines New Day's clinically validated CRC liquid biopsy technology with Daisy Genomics' physics-based optical sequencing platform. Research conducted across New Day's CLIA-certified laboratory and University of Tennessee facilities.
- University of TennesseecoreMulti-institution collaboration supporting next-generation epigenetic sequencing research. Partners aim to leverage the university's manufacturing and research infrastructure, including the Institute for Advanced Materials & Manufacturing, to generate foundational clinical data for scalable cancer screening tools.
- East Tennessee Health Innovation AlliancecoreCollaboration supporting advancement of liquid biopsy tools for early colorectal cancer detection, focused on reaching underserved patient populations through multi-institution alliance.
- SehaMed Global Ltd.coreStrategic distribution agreement to launch ColoHealth blood test for colorectal cancer screening across the Middle East. SehaMed is a Bristol-based MedTech platform connecting manufacturers, distributors, and hospitals worldwide, enabling entry into high-growth international markets.
- Hepion PharmaceuticalscoreBinding letter of intent to commercialize tests for Celiac Disease, respiratory multiplex (COVID-Flu-RSV), H. pylori, and hepatocellular carcinoma (HCC). Hepion is a clinical-stage biopharmaceutical company developing treatments for NASH and HCC.
- AugurexcoreCollaboration to launch SPINEstat, a first-of-its-kind multiplex biomarker assay for transforming the early diagnosis and management of ankylosing spondylitis. Augurex is based in Vancouver, BC, Canada.
- Epigenomics AGcoreAsset purchase agreement to acquire substantially all assets and intellectual property from Berlin-based Epigenomics AG. Includes 450 patents and proprietary biomarker technology for methylated DNA detection, including Epi proColon CRC screening test.
- EDP Biotech Corp.coreAsset merger combining EDP Biotech's position as established specialty diagnostic developer and CRO with New Day Diagnostics' pipeline and commercialization capabilities, forming a vertically integrated diagnostics powerhouse.
Scale indicators5 records
Recent moves6 records
Expansion highlights6 records
New Day Diagnostics competitors and assessment
Company assessmentEmerging players
- CellMax Life: CellMax Life develops blood-based ctDNA tests for early cancer detection including colorectal, prostate, and other cancers, putting it in direct technological adjacency with NDD's mSEPT9 and prostate cancer pipeline programs.
- GRAIL: GRAIL's Galleri is a multi-cancer early detection (MCED) blood test that overlaps with NDD's stated 10-year goal of a universal liquid biopsy platform. Both companies pursue methylation-based detection of cell-free DNA, though GRAIL focuses on multi-cancer vs. NDD's CRC-first approach.
Direct peers
- Freenome: Freenome is developing a multi-analyte blood test for early CRC detection using methylation and other biomarkers, going head-to-head with NDD's mSEPT9 and future ColoPlex Plus multi-target assay in the same clinical and commercial channel.
- Guardant Health: Guardant Health's Shield is a blood-based ctDNA CRC screening test approved by FDA and covered by Medicare, directly competing with ColoHealth's value proposition. Guardant also pursues multi-cancer detection, mirroring NDD's stated liquid biopsy platform ambitions.
Regional players
- Singlera Genomics: Singlera Genomics is a Shanghai-based liquid biopsy and early cancer detection developer pursuing methylation-based blood tests similar to NDD's mSEPT9 technology. It is relevant as a regional peer addressing Asian CRC screening markets where NDD has signaled interest.
Others
- Bio-Techne: Bio-Techne provides protein-based research and diagnostic reagents and assay kits that overlap with NDD's Luminex xMAP-based ColoPlex and SPINEstat multiplex biomarker assays, sitting in the same biomarker tools and diagnostic reagents supply chain.
Broad incumbents
- NeoGenomics: NeoGenomics operates CLIA-certified specialty oncology laboratories offering biomarker testing services to oncologists, pharma, and CRO clients, directly paralleling NDD's New Day Bioresearch CRO services arm and clinical biomarker testing offering.
- Exact Sciences: Exact Sciences markets Cologuard, the dominant non-invasive CRC screening test (stool DNA-based), and has scaled to billions in revenue with full Medicare coverage. It is the primary commercial benchmark for any non-invasive CRC screening entrant, including NDD's blood-based ColoHealth.
- Quest Diagnostics: Quest Diagnostics operates one of the largest U.S. medical laboratory networks including molecular and specialty oncology testing. It is a comparable CLIA-certified lab services peer and also a potential channel partner for ColoHealth physician volume.
- Labcorp/Covance: Labcorp's diagnostics and Covance CRO arms parallel NDD's two-sided commercial model (clinical lab + CRO services), and Labcorp's scale and payer contracts represent both a competitive threat and a potential distribution channel for ColoHealth.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights7 records
Customer concentration
New Day Diagnostics social profiles
Digital presenceNew Day Diagnostics compliance and trust
Trust signalCompliance2 records
New Day Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
New Day Diagnostics leadership team
Management profileNumber of profiles
Profiles19 records
New Day Diagnostics funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
New Day Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about New Day Diagnostics
What does New Day Diagnostics do?
New Day Diagnostics develops and commercializes blood-based molecular diagnostic tests, with its flagship ColoHealth product providing non-invasive colorectal cancer screening via Real-Time PCR detection of the methylated Septin 9 (mSEPT9) biomarker from a routine blood draw. The company also operates New Day Bioresearch, a Contract Research Organization offering end-to-end assay design, analytical validation, clinical trial management, and regulatory strategy services for pharmaceutical and biotech sponsors.
Is New Day Diagnostics a public or private company?
New Day Diagnostics is a private company. It is classified as venture growth investor backed and is currently operating.
When was New Day Diagnostics founded?
New Day Diagnostics was founded in 2005. It employs 1 to 10 people.
Where is New Day Diagnostics based?
New Day Diagnostics is headquartered in Boca Raton, United States, in the North America region.
How does New Day Diagnostics make money?
Three revenue lines are on record. ColoHealth Direct Sales are the primary driver. The others are professional Laboratory Services and CRO Services (New Day Bioresearch).
Who are New Day Diagnostics's main competitors?
Emerging players on record are CellMax Life and GRAIL. Direct peers are Freenome and Guardant Health. Singlera Genomics is listed as a regional player. Bio-Techne is listed as an others. Broad incumbents are NeoGenomics, Exact Sciences, Quest Diagnostics and Labcorp/Covance.
Does New Day Diagnostics have an API?
No public API is recorded for New Day Diagnostics.
What industry is New Day Diagnostics in?
New Day Diagnostics's product category is Molecular Cancer Diagnostics. Its primary akta.pro industry code is HLAAANAG, Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing, with a secondary code of HLAIALAF, Translational Medicine & Biomarkers. Its NAICS code is 621511 and its SIC code is 8071.