What Cubit does

Cubit Diagnostics is a pre-commercial medical device company developing the Omnio™ multimodal point-of-care diagnostics platform. Founded in 2023 and headquartered in Carlsbad, California, the company is targeting sexually transmitted infection (STI) testing as its lead clinical application through a CT/NG/TV (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis) molecular assay, with design freeze targeted for Q4 2026 and clinical study in H1 2027.

The company's core technology, the Omnio platform, integrates two complementary diagnostic modalities — nucleic acid amplification-based molecular testing and immunoassay testing — into a single benchtop system intended for use at the point of care. This integration is designed to enable healthcare providers to perform rapid, multiplexed diagnostics on-site rather than sending samples to centralized laboratories, with same-visit clinical decision-making positioned as the primary value proposition. The platform's modular architecture is intended to support an expanding test menu across both modalities.

Cubit operates a pre-commercial hardware-plus-consumables revenue model, with future monetization expected through sales of diagnostic instruments paired with proprietary test cartridges and kits. The planned go-to-market motion is enterprise field sales targeting healthcare providers, urgent care centers, and point-of-care testing environments. Capital raised to date includes a $2.6 million NIH RADx Tech grant and an undisclosed SAFE financing round closed in May 2026, both of which are funding the design freeze and clinical validation milestones. The company currently has 1–10 employees, is privately held, and is not yet generating revenue.

Name

Cubit

Legal name

Cubit Diagnostics

Website

https://cubitdx.com

Company type

Private

Founded year

2023

Operating status

Operating

Headcount range

1–10 employees

Short description

Cubit Diagnostics is a pre-commercial medical device company developing the Omnio™ multimodal point-of-care diagnostics platform, which integrates molecular and immunoassay testing into a single benchtop analyzer, initially targeting STI testing for healthcare providers and point-of-care settings.

Ownership category

akta.pro rank

Product category

Point-of-Care Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Pregnancy, Fertility & Women’s Health Rapid Tests (hCG, ovulation, vaginal infection) (HLAHAOAF)

akta.pro secondary industry

Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI)

Keywords

• Point-of-care diagnostics
• Molecular diagnostics
• Immunoassay testing
• Benchtop analyzers
• Multimodal diagnostics

Headquarters

HQ city

Carlsbad

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Testing Platform and Consumables: As a diagnostics company developing a point-of-care testing platform, Cubit Diagnostics will generate revenue through the sale of diagnostic instruments and associated consumables (test cartridges/kits) for its Omnio platform. The company is pre-commercial, with design freeze targeted for Q4 2026 and clinical study planned for H1 2027.

Go-to-market motion1 record

Marketing channels2 records

Core offering

Cubit Diagnostics develops and manufactures the Omnio™ platform, an integrated benchtop point-of-care diagnostics system that combines molecular diagnostics and immunoassay testing modalities in a single device. The company is pre-commercial, with its first molecular assay (CT/NG/TV for sexually transmitted infections) targeted for design freeze in Q4 2026 and clinical study in H1 2027. Revenue, once commercialized, will come from instrument sales paired with consumable test cartridges/kits.

Product overview

Cubit offers the Omnio™ multimodal diagnostics platform, which integrates two testing modalities—molecular and immunoassay—into a single unified system. The platform is designed for point-of-care use and is being developed with an expanding test menu, including the CT/NG/TV molecular assay currently in late-stage development.

Differentiator

Problem solved

Functional benefit

Brands

• Omnio™: A multimodal (molecular and immunoassay) point-of-care diagnostics platform enabling integrated diagnostic testing through a single device.

Products and services

• Omnio™ Multimodal Diagnostics Platform A unified, benchtop point-of-care diagnostics platform that integrates molecular diagnostics and immunoassay testing modalities into a single device, designed for healthcare facilities, clinics, urgent care centers, and point-of-care testing environments requiring rapid, multiplexed diagnostic results.
• CT/NG/TV Molecular Assay A multiplex molecular diagnostic assay designed to detect Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) at the point of care, intended to run on the Omnio platform for healthcare providers offering rapid STI screening.

Segments1 record

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Abbott (Diagnostics): Abbott provides a broad diagnostics portfolio including the ID NOW rapid molecular POC platform, the m-PIMA HIV/virology POC system, and Alere immunoassay products. Its wide menu and global commercial footprint make it a broad incumbent competing across the same POC testing categories Cubit targets.
• QuidelOrtho: QuidelOrtho is a major diagnostics company spanning rapid immunoassay (Sofia, Triage) and molecular products, including Savanna. Its board overlap with Cubit and broad POC menu make it both a potential acquirer and a benchmark for go-to-market execution.
• QIAGEN (stat-of-the-art rapid molecular): QIAGEN provides sample-prep and molecular testing technologies used across STI workflows (e.g., QIAstat-Dx), including in decentralized settings. As a broad life-science tools incumbent expanding into rapid molecular POC, it represents a competitive threat to Omnio's adoption in mid-complexity labs.

Direct peers

• Hologic: Hologic's Panther and Aptima systems are the leading molecular diagnostics platforms for chlamydia, gonorrhea, and Trichomonas testing, primarily in central-lab settings. It defines the gold-standard molecular STI testing workflow that a faster POC platform like Omnio would aim to disrupt.
• bioMérieux (BioFire): BioFire, a bioMérieux subsidiary, markets the FilmArray multiplex molecular POC panels (e.g., respiratory, GI, meningitis/encephalitis). Its success in moving syndromic molecular testing out of central labs directly parallels the Omnio strategy of broadening POC molecular menu.
• binx health: binx health has commercialized the io CT/NG rapid molecular POC test, with FDA clearance for use in CLIA-waived settings. It directly competes with Cubit's planned CT/NG/TV POC molecular assay for STI testing at point of care.
• Visby Medical: Visby Medical develops a palm-sized PCR-based point-of-care STI testing platform for CT/NG/TV. It is one of the closest direct competitors to Cubit, targeting the same POC STI workflow with a single-use molecular device.
• Cepheid (BD): Cepheid, owned by Becton Dickinson, sells the GeneXpert molecular point-of-care systems used for CT/NG/TV and other infectious disease testing in CLIA-waived and moderate-complexity settings. It is the dominant POC molecular diagnostics competitor that Cubit's Omnio platform is positioned against.

Emerging players

• Accelerate Diagnostics: Accelerate Diagnostics sells rapid AST and molecular identification systems aimed at reducing time-to-result in infectious disease diagnostics. It is comparable as a smaller, focused diagnostics player pushing rapid, decentralized testing workflows similar to Omnio's value proposition.
• NOWDiagnostics: NOWDiagnostics develops over-the-counter and point-of-care diagnostic tests across multiple analytes using proprietary membrane-based immunoassay and molecular approaches. Its focus on inexpensive, rapid POC testing across modalities makes it a useful emerging-player analog to Cubit's multimodal strategy.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/cubitdx

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds2 records

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 Cubit