New_Diagnostics

What New_Diagnostics does

New_Diagnostics GmbH is a Berlin-headquartered, privately held biotechnology company developing bioanalytical solutions for food, environmental, and medical applications. Its core technology is a portfolio of yeast-based biosensor assays built on two engineered yeast platforms — Arxula adeninivorans and Saccharomyces cerevisiae — with stably integrated human nuclear receptors (estrogen, androgen, progestagenic, mineralocorticoid, thyroid, AhR/ARNT, RXRA) used as the biological measuring component for effect-based detection of endocrine disruptors, hormones, and trace substances. Detection modes span absorbance, fluorescence, luminescence, and visual readout. Commercial products include the ISO 19040-2:2018-standardized A-YES, S-YES, S-YESbasic, S-YTSβ, Speed-YESMD, A-YBSlumi, and the in-development A-YMS, alongside a new cfDNA reference materials line for liquid biopsy under the liquid-biopsy.new-diagnostics.com brand.

The company operates a B2B sales-led model, selling standardized test kits directly to laboratories via its own e-commerce web shop with global shipping, unit pricing of approximately €200-300 per kit, special university and NGO pricing, volume discounts, and quote-based enterprise pricing. It supplements kit sales with certified analytical laboratory services and interlaboratory trial organization through its Dresden facility. Customer segments span environmental testing laboratories, food safety and consumer-product QC laboratories, academic and regulatory research institutions, and (newly) clinical laboratories using cfDNA reference materials. The company maintains a core strategic partnership with QuoData on interlaboratory studies and EQA Biotests proficiency testing programs, and operates a small team (1-10 employees) across Berlin administration and Dresden R&D/laboratory functions.

Name

New_Diagnostics

Legal name

new_diagnostics GmbH

Website

https://new-diagnostics.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

1–10 employees

Short description

New_Diagnostics is a Berlin-based biotech company selling standardized yeast-based biosensor test kits for effect-based detection of endocrine disruptors, hormones, and bisphenols, plus new cfDNA reference materials for liquid biopsy, serving environmental, food safety, academic, and clinical laboratories worldwide.

Ownership category

akta.pro rank

Product category

Biosensor Test Kits

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Services-Testing Laboratories (8734)

akta.pro primary industry

Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA)

akta.pro secondary industries

Risk Assessment, Hazard Analysis & Food Defense/Fraud Programs (AFALAAAO), Clinical Chemistry & Hematology Diagnostics (automated analyzers, blood testing) (HLAAALAH)

Keywords

• Yeast biosensor assays
• Endocrine disruptor detection
• Effect-based bioanalysis
• Water quality testing kits
• CfDNA reference materials

Headquarters

HQ city

Berlin

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Supply Chain, Infrastructure, Marketing or Sales

Revenue model

1. Yeast-based Assay Test Kits: Sale of standardized effect-based test kits including A-YES, S-YES, A-YBSlumi, and related products. Products are sold directly to business customers through web shop with pricing from €200-300 per kit. Includes ready-to-use, eco/plus, and flexible component formats.
2. cfDNA Reference Materials: Cell-free DNA reference materials for liquid biopsy applications sold through dedicated liquid-biopsy.new-diagnostics.com platform. Targets clinical and research laboratories requiring quality control materials for ctDNA detection validation.
3. Analytical Test Services: Certified laboratory services for sample testing using the company's proprietary yeast-based biosensor technology. Provides end-to-end analytical services for environmental monitoring and food safety applications.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

new_diagnostics develops, manufactures, and sells standardized yeast-based biosensor assay kits for effect-based detection of endocrine disruptors, hormones, and trace substances in water, food, and consumer products. The portfolio uses two proprietary genetically modified yeast species—Arxula adeninivorans and Saccharomyces cerevisiae—as biological detection components, with multiple read-out modes. The company also produces cfDNA reference materials for liquid biopsy quality control and provides certified analytical laboratory testing services.

Product overview

new_diagnostics is a bioanalytical solutions provider offering a portfolio of yeast-based biosensor products for effect-based measurement of endocrine disruptors, hormones, and trace substances. The product line centers on two genetically modified yeast species—Arxula adeninivorans and Saccharomyces cerevisiae—as biological measuring components. The core portfolio includes standardized and validated assay kits: A-YES (ISO 19040-2:2018 standardized), S-YES, S-YESbasic, S-YTS (thyroid screen), A-YBSlumi (bisphenol screen with luminescence), Speed-YESMD, and A-YMS (mineralocorticoid screen in development). These detect measurands including androgens, estrogens, glucocorticoids, progesterones, thyroid hormones, bisphenols, and dioxins using detection modes of absorbance, fluorescence, luminescence, or visual assessment. The company also offers cfDNA Reference Materials for liquid biopsy applications supporting digital PCR and NGS technologies, and provides laboratory testing services through its certified facility. An associated web platform, BioVAL, provides statistical analysis and reporting for test results.

Differentiator

Problem solved

Functional benefit

Brands

• BioVAL: Web-based statistical analysis and reporting tool for test results, provided free with test kit purchases.
• A-YBSlumi
• Speed-YESMD
• S-YESbasic
• A-YMS
• Liquid Biopsy

Products and services

• A-YES (Arxula-Yeast Estrogen Screen) ISO 19040-2:2018 standardized yeast-based biosensor assay using Arxula adeninivorans with photometric detection for the determination of estrogenic effects. Used by environmental water quality monitoring laboratories and food safety quality control operations.
• S-YES (Saccharomyces-Yeast Estrogen Screen) Affordable yeast-based biosensor assay using Saccharomyces cerevisiae for the detection of estrogenic effects in various aqueous samples. Designed for environmental monitoring laboratories requiring a versatile assay platform.
• S-YESbasic (Saccharomyces-Yeast Estrogen Screen basic) Simple and fast effect-based cuvette test for the detection of estrogenic activity in various water samples using Saccharomyces cerevisiae as the estrogen responsive biosensor. Delivers results in approximately 4 hours with photometric detection at 580 nm and a limit of detection of 12.8 ng/L.
• S-YTS (Saccharomyces-Yeast Thyroid Screen β) Yeast-based biosensor assay using Saccharomyces cerevisiae for the determination of thyroid receptor β mediated effects in various aqueous samples with photometric detection. Used for environmental water and food safety applications.
• A-YBSlumi (Arxula-Yeast Bisphenol Screen Luminescence) Effect-based 96-well assay using Arxula adeninivorans with luminescence detection for fast and sensitive determination of cumulative bisphenol activity. Specific for bisphenol A and bisphenol Z detection with assay duration of approximately 4.5 hours.
• Speed-YESMD (Speed-Yeast Estrogen Screen) Improved yeast estrogen screen delivering super fast results in as low as 6 hours with a user-friendly protocol that eliminates elaborate yeast culture and serial dilutions. Completed in-house factorial validation.
• A-YES for Extracts Adopted version of the ISO standardized A-YES test designed for handling extracts with limited sample volumes. Uses a 96-well format with 3D print prototyping to enable low-volume testing for food safety and environmental extract samples.
• cfDNA Reference Materials Cell-free DNA reference materials derived from authentic cancer cell lines for liquid biopsy applications. Enables ctDNA detection validation, sensitivity optimization down to 0.1% VAF, and cross-platform validations across NGS, qPCR, and digital PCR platforms. Sold to clinical and research laboratories.
• Laboratory Testing Services Certified laboratory analytical services for customer sample testing using the company's proprietary yeast-based biosensor technology. Includes interlaboratory trial organization for effect-based in vitro methods for the determination of hormonal activity. Provided to environmental monitoring and food safety customers.

Quantifiable outcome

• Detection of endocrine disrupting effects at low ng/L concentrations
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• QuoDatacoreStrategic or Co-development PartnerParent company and strategic partner providing interlaboratory studies and proficiency testing programs for effect-based in vitro methods. QuoData organizes the 'Hormonal Effects' interlaboratory trial and EQA Biotests proficiency testing programs. Relationship involves shared research and development collaboration.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Xenometrix: Swiss developer of the original Yeast Estrogen Screen (YES) and related yeast- and mammalian-cell reporter assays for endocrine disruptor screening — a foundational competitor to New_Diagnostics' S-YES and S-YESbasic estrogen assays.
• Indigo Biosciences: US-based provider of nuclear receptor reporter assays (estrogen, androgen, thyroid, glucocorticoid, etc.) for screening hormonal activity — comparable in product architecture (receptor-based reporter assays) and target customers (environmental, food safety, and research labs).
• SeraCare Life Sciences (LGC Clinical Diagnostics): Major provider of cfDNA and ctDNA reference materials for liquid biopsy assay validation, including matched mutation and VAF standards — directly competes with New_Diagnostics' newly launched cfDNA reference materials product line.
• BioDetection Systems: Dutch developer of the CALUX (Chemical Activated LUciferase gene eXpression) reporter gene bioassays for estrogens, androgens, dioxins, and other endocrine-active compounds — directly competes with New_Diagnostics' yeast-based A-YES, A-YBS, and broader effect-based test kit portfolio in water and food testing markets.
• Horizon Discovery (Revvity): Provider of cell-line-derived reference standards, including cfDNA and oncology controls for liquid biopsy QC, comparable to New_Diagnostics' authentic cell-line cfDNA reference materials for ctDNA detection validation.

Broad incumbents

• Eurofins Scientific: Global testing services group with large environmental, food, and clinical/biopharma testing operations — a major incumbent buyer of bioanalytical methods (including effect-based assays) and a potential distribution channel or competitive threat for New_Diagnostics' laboratory services and kits.
• bioMérieux: Global in vitro diagnostics and microbiology company with industrial applications including food safety testing kits and instruments — overlaps with New_Diagnostics' food safety and environmental testing customer base, though at a much broader portfolio level.
• Promega Corporation: Established life-science tools company offering bioassay reagents, reporter systems, and nucleic acid extraction/detection products relevant to molecular diagnostics and bioanalytical workflows — broadly comparable to New_Diagnostics' bioanalytical reagent and reporter-gene assay portfolio.

Others

• QuoData: Listed as parent/strategic partner of New_Diagnostics; provides interlaboratory studies, proficiency testing, and statistical validation services for bioassays — adjacent ecosystem participant that anchors New_Diagnostics' EQA Biotests and 'Hormonal Effects' proficiency testing programs.

Emerging players

• AccuRef Diagnostics: Developer of cell-free DNA reference materials for liquid biopsy assays — a smaller, niche player in the same reference-materials space that New_Diagnostics is entering with liquid-biopsy.new-diagnostics.com.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/new-diagnostics-bioanalytical-solutions-for-food-the-environment-and-medical-applications
• Xx.com/newdiagnostics

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about New_Diagnostics