Delphine Diagnostics

What Delphine Diagnostics does

Delphine Diagnostics Inc. is a Newark, New Jersey-based medical diagnostics startup founded in 2020 that is building a bundled offering combining real-time PCR-based sepsis diagnostic test kits with an AI/ML clinical decision support platform. The company's flagship sepsis assay is designed to detect pathogen and host markers and reduce time-to-diagnosis from the roughly 72-hour blood culture standard to a targeted 4 hours; the AI/ML layer — an ensemble of three machine learning models described as POC-verified — is intended to recommend antimicrobial regimen, dosage, and duration using patient data, treatment guidelines, and clinical outcomes. The company also previously secured FDA notification acceptance for the Delphine PrecisQT COVID-19 Test Kit (April 2021), restricted to CLIA-certified high-complexity laboratories, and lists SepSeek, CDSA, and a Research Use Only (RUO) product line on its site.

The company's revenue model is built on three streams: sale of certified diagnostic test kits (hardware sales), subscription/recurring software applications for clinical decision support, and technical support services for labs and clinicians. Go-to-market is described as direct enterprise field sales to certified healthcare facilities and CLIA-certified laboratories, supplemented by partnerships with research institutions, healthcare networks, and accelerator ecosystems (NJ CSIT, BioNJ, Sepsis Alliance SIC, Rutgers Business School, IITStartups). Primary customer segments are hospitals and healthcare providers focused on sepsis diagnosis and antimicrobial optimization, with secondary exposure to maternal and infant health (via the 2025 NJ CSIT award) and clinical laboratories. The company reports 1-10 employees, operates from the NJ Institute of Innovation in Newark with an R&D lab at Kean University's Institute for Life Science Entrepreneurship, and as of 2025 is actively pitching at investor demo days while remaining pre-commercial on its core sepsis product.

Name

Delphine Diagnostics

Legal name

Delphine Diagnostics Inc.

Website

https://delphinedx.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

1–10 employees

Short description

Delphine Diagnostics is a Newark, New Jersey-based startup developing PCR-based sepsis diagnostic kits bundled with an AI/ML clinical decision support platform for hospitals, clinical laboratories, and maternal/infant health providers.

Ownership category

akta.pro rank

Product category

In-Vitro Diagnostics / Clinical Decision Support

NAICS

Medical Laboratories (621511)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Sepsis, Deterioration & Rapid Response CDS (HLACAGAF)

akta.pro secondary industries

Infectious Disease POCT (Respiratory, STI, HIV, Sepsis) (HLAHAOAA), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)

Keywords

• Molecular diagnostics
• Sepsis detection
• Clinical decision support
• PCR test kits
• AI diagnostics

Headquarters

HQ city

Newark

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales

Revenue model

1. Diagnostic Test Kits: Sale of certified diagnostic testing kits including sepsis diagnostic assay and COVID-19 test kits to healthcare facilities.
2. AI/ML Software Applications: Advanced software applications for data analysis and diagnostic accuracy enhancement, providing clinical decision support to healthcare providers.
3. Technical Support Services: Technical support services for labs and clinicians, including software applications for treatment guidance.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

Delphine Diagnostics develops and supplies certified molecular diagnostic test kits (real-time PCR for sepsis and previously COVID-19) alongside an AI/ML clinical decision-support application aimed at hospitals, CLIA-certified laboratories, and clinicians. The combined PCR panel plus AI interpretation engine targets faster sepsis diagnosis (reported goal of ~4 hours vs. ~72 hours for blood culture) and personalized antimicrobial regimen selection.

Product overview

Delphine Diagnostics offers a bundled diagnostic offering that combines PCR-based sepsis diagnostic test kits with an AI/ML interpretation engine for sepsis detection and clinical decision-making. The core portfolio includes the Delphine Sepsis Diagnostic Test Kit (real-time PCR technology for pathogen and host marker detection), the Delphine AI/ML Healthcare Platform, and the Sepsis Prediction Using ML Tool (POC Verified with ensemble of three machine learning models). The company also previously offered the Delphine PrecisQT™ COVID-19 Test Kit. These products work together to provide comprehensive sepsis diagnosis and AI-driven treatment decision support for healthcare providers.

Differentiator

Problem solved

Functional benefit

Brands

• Delphine PrecisQT™: A COVID-19 Test Kit based on real-time reverse transcription polymerase chain reaction (RT-PCR) technology for qualitative detection of nucleic acid from the SARS-CoV-2 virus.
• SepSeek
• CDSA

Products and services

• Delphine PrecisQT™ COVID-19 Test Kit Real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 virus in nasopharyngeal and oropharyngeal swabs from individuals suspected of having COVID-19, intended for use in CLIA-certified high-complexity laboratories.
• Delphine Sepsis Diagnostic Test Kit Real-time PCR-based sepsis diagnostic assay providing detection of pathogen and host markers to support personalized patient care and antimicrobial regimen selection in hospitals and certified laboratories.
• Delphine AI/ML Healthcare Platform AI and machine learning platform that analyzes patient information, treatment guidelines, and clinical outcomes to support clinicians in sepsis prediction and selection of the most appropriate antimicrobial regimen, dosage, and duration, intended for hospitals and certified laboratories.
• Sepsis Prediction Using ML Tool POC Verified AI/ML tool applying an ensemble of three machine-learning models to predict sepsis risk and support clinical decision-making for clinicians.
• RUO (Research Use Only) Research Use Only products offered by Delphine Diagnostics for research and non-clinical investigative use.
• SepSeek & CDSA Sepsis-related diagnostic products referenced alongside the company's core sepsis offering; limited detail is available in the source data.

Quantifiable outcome

• Reduces sepsis diagnosis time from 72 hours to 4 hours
• +1 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature4 records

Partnerships

Seven partnerships are on record, tiered minor and core.

• IITStartups AcceleratorminorGTM or Marketing Partner · 1 July 2025Delphine Diagnostics participated in IITStartups accelerator's Cohort 13, a 12-week intensive program providing mentoring and coaching to firms founded by alumni of IITs in India. The company pitched at Silicon Valley Demo Day in July 2025 to a audience of 250+ investors, VCs, and CEOs.
• BioNJcoreGTM or Marketing Partner · 1 July 2024Delphine Diagnostics actively participates in BioNJ events including Manufacturing Briefing 2022, 2024 AI & Digital Health Day, and other BioNJ programming. BioNJ provides a platform for networking with industry leaders, investors, and potential partners in the New Jersey biotech ecosystem.
• New Jersey Commission on Science Innovation and Technology (NJ CSIT)coreStrategic or Co-development Partner · 1 June 2023Delphine Diagnostics engaged with NJ CSIT through the CSIT Voucher Program, which was pivotal in advancing cutting-edge research in enhanced diagnostics. The company also participated in CSIT-organized roundtables and received the Maternal and Infant Health Award grant in 2025.
• Rowan University/RutgersminorStrategic or Co-development Partner · 1 April 2023Delphine Diagnostics participated in a state-level roundtable discussion organized by NJ CSIT at Rutgers and Rowan University's Translational Research Facility in Camden, NJ, addressing issues facing the life sciences ecosystem.
• Sepsis Innovation Collaborative (SIC)coreStrategic or Co-development Partner · 1 July 2022Delphine Diagnostics became an inaugural member of the Sepsis Innovation Collaborative, a multi-stakeholder public/private collaborative launched by Sepsis Alliance. The collaboration aims to address challenges related to infection management and sepsis prevention, detection, treatment, and survivor support through public-private communication, developing a common sepsis lexicon, and accelerating time-to-market of novel products.
• Rutgers Business SchoolcoreStrategic or Co-development Partner · 1 March 2022Ongoing collaboration with Rutgers Business School students for real-world business experience and actionable insights. The partnership provides students with hands-on experience while Delphine benefits from student research and analysis. Continued collaboration in 2024 as part of the Industry Client Project course.
• BAJ Accelerator ProgramminorGTM or Marketing Partner · 1 January 2022Delphine Diagnostics participated in the NYC-based BAJ Accelerator Program as of January 2022 Cohort #7. The program provided networking opportunities, coaching, training, and resources to startups at Seed to Series A+ levels. Topics included technology, legal, finance, sales, marketing, leadership, and exponential thinking.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• T2 Biosystems: Developer of T2Bacteria and T2Candida panels for rapid sepsis pathogen identification directly from whole blood. Closest direct competitor to Delphine's PCR-based rapid sepsis assay.
• Cytovale: Commercializes IntelliSep, a rapid cellular biomarker sepsis triage test that produces results in under 10 minutes from a blood draw. Competes head-to-head with Delphine on speed of clinical decision-making for sepsis.
• Inflammatix: Developer of host-response diagnostics and AI/machine-learning classifiers (e.g., Inflammatix Acute Infection and Sepsis) for rapid sepsis triage and antibiotic decision support. Directly comparable AI/ML-on-diagnostic approach.
• Prenosis: AI-driven sepsis prediction platform (Sepsis ImmunoScore / InSight) that combines biomarker data with ML to support early clinical decision-making. Closely overlaps Delphine's AI clinical-decision-support value proposition.
• Accelerate Diagnostics: Commercializes the Accelerate Pheno system for rapid identification and antimicrobial susceptibility testing (AST) of bloodstream infections, addressing the same sepsis-treatment-decision workflow Delphine targets.

Broad incumbents

• BioFire Diagnostics (bioMérieux): Market-leading FilmArray multiplex PCR panels (Blood Culture Identification, Pneumonia) widely adopted in hospital labs. Sets the competitive ceiling for any syndromic sepsis / infectious-disease molecular panel entrant.
• Cepheid (Danaher): GeneXpert PCR platform with broad infectious-disease menu and global installed base. Defines the standard for hospital molecular diagnostics workflow that any new PCR entrant must integrate with or displace.
• Roche Diagnostics: Global IVD incumbent offering molecular diagnostics, clinical chemistry, and digital decision-support solutions across the sepsis and infectious-disease workflow. Competes across both the kit and the clinical-decision-support layers.
• QIAGEN: Major molecular sample-prep and PCR diagnostics supplier (e.g., QIAstat-Dx Respiratory Panel) used by hospital labs. Comparable as a PCR platform competitor in the infectious-disease diagnostic space.

Emerging players

• Inflammatix: Already listed as a direct peer; also flagged as an emerging AI-first diagnostics player building host-response classifiers before broad commercialization, mirroring Delphine's pre-revenue AI-diagnostic posture.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/IncDelphine
• Facebookfacebook.com/delphinediagnostics
• LinkedInlinkedin.com/company/delphine-diagnostics-inc

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds1 record

Investors1 record

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 Delphine Diagnostics