NanoDx

What NanoDx does

NanoDx (formerly BioDirection) is a pre-revenue, privately held medical device company founded around 2010 and headquartered in Southborough, Massachusetts, that is commercializing a hand-held point-of-care diagnostic platform built around a proprietary nano biosensor. The core technology combines silicon nanowires coated with biomarker-specific antibodies, licensed from Harvard University and from IBM Research in the case of CMOS-compatible fabrication, to detect proteins by measuring minute changes in electrical resistance, producing results in approximately four minutes from a fingerstick blood sample with no reagents or sample preparation required. The lead clinical application is the NanoDx Tbit Test for traumatic brain injury, which simultaneously measures three biomarkers (GFAP, S100B, and UCH-L1); a 100-subject pre-clinical feasibility study reported 100% sensitivity with no false negatives, and the system has received FDA Breakthrough Device Designation, though full FDA clearance has not been disclosed.

The intended business model is a razor-and-blade structure: placement of a reusable analyzer (planned direct sales plus distribution through channel partners) complemented by recurring single-use cartridge revenue, with quote-based, multi-year enterprise pricing positioned at the premium end of the point-of-care testing spectrum. Primary customers are hospital emergency departments and urgent care facilities seeking to triage mild TBI more accurately than the Glasgow Coma Scale and to reduce the more than 90% of CT scans currently deemed unnecessary; secondary use cases target sports medicine (sideline concussion assessment), military and veterans healthcare (in collaboration with the Home Base Program), and infectious disease testing (COVID-19). The platform is designed to be extensible, with stated future applications in stroke, sepsis, influenza, and oncology, and a claimed new-assay development timeline of 6–9 months on the same sensor architecture.

Manufacturing is anchored by a partnership with SkyWater Technology, a US-based semiconductor foundry that has implemented specialized processes for NanoDx's nanoscale sensors, and the company has built out an executive bench including a former IBM EVP as technical and strategic advisor, an ex-Siemens Healthineers POC/IVD commercial leader as Chief Commercial Officer, and a military advisory board of retired senior officers to support defense procurement channels. As of November 2025, NanoDx has consolidated its Cambridge and Albuquerque teams into a single product development facility in Watertown, Massachusetts, while maintaining its corporate headquarters in Southborough.

Name

NanoDx

Legal name

NanoDx, Inc.

Website

https://nanodiagnostics.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

1–10 employees

Short description

NanoDx is a pre-revenue medical device company developing a point-of-care nano biosensor diagnostic platform, with its lead application being a rapid traumatic brain injury test measuring three biomarkers from a fingerstick blood sample in approximately four minutes.

Ownership category

akta.pro rank

Product category

Point-of-Care Medical Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Biosensors & Lab-on-Chip (BioMEMS) (HDAHALAK)

akta.pro secondary industry

Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL)

Keywords

• Point-of-care diagnostics
• Traumatic brain injury testing
• Nano biosensor platform
• Rapid biomarker detection
• Handheld diagnostic devices

Headquarters

HQ city

Southborough

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Point-of-Care Diagnostic Hardware: Sale of the NanoDx System including reusable analyzer and single-use cartridges. The company has received $18M in funding to pursue commercialization of its platform for TBI and COVID-19 tests.
2. Diagnostic Test Kits/Cartridges: Recurring revenue from single-use test cartridges that are placed in the analyzer for each test. Each cartridge contains nanosensors coated with antibodies specific to target biomarkers.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

NanoDx develops and commercializes a handheld point-of-care diagnostic platform (the NanoDx™ System) that uses silicon nanowire nano biosensor technology to quantitatively measure disease biomarkers from a small fingerstick blood sample in approximately four minutes. The system pairs a reusable analyzer with single-use test cartridges, with the first commercial application being the NanoDx™ Tbit™ Test for traumatic brain injury, which simultaneously measures three biomarkers (GFAP, S100B, UCH-L1). Results are delivered to electronic health records via a HIPAA- and GDPR-compliant cloud platform, and the platform is designed for extensible multiplexing into future applications including COVID-19, sepsis, stroke, and infectious disease.

Product overview

NanoDx offers a unified platform-and-application architecture centered on the NanoDx™ System, a first-of-its-kind point-of-care diagnostic device using patented nano biosensor technology. The core platform combines nanotechnology, semiconductor, and biochemistry into a nano biosensor capable of rapid biomarker detection from a small blood sample in approximately 4 minutes. The first commercial application is the NanoDx™ Tbit™ Test for traumatic brain injury (TBI), which measures three biomarkers (GFAP, S100B, UCH-L1) and has received FDA Breakthrough Device Designation. The platform is designed for expandable multiplexing capability, with potential future applications including COVID-19, sepsis, stroke, infectious diseases, and oncology. The system includes a handheld analyzer, single-use cartridges, cloud connectivity for EHR integration, and a web-based customer portal for data management.

Differentiator

Problem solved

Functional benefit

Products and services

• NanoDx™ System A first-of-its-kind point-of-care diagnostic platform that combines nanotechnology, semiconductor, and biochemistry into a nano biosensor capable of rapid biomarker measurement from a small fingerstick blood sample in approximately 4 minutes. The system includes a handheld analyzer with single-use test cartridges and IoT-enabled cloud connectivity for HIPAA- and GDPR-compliant EHR integration. Targeted at hospital emergency rooms, urgent care, doctors' offices, military medical facilities, and sports medicine programs.
• NanoDx™ Tbit™ Test The first commercial application of the NanoDx System: a traumatic brain injury diagnostic test that delivers accurate, quantitative measurement of three biomarkers (GFAP, S100B, UCH-L1) from a fingerstick blood sample using the NanoDx System platform. Provides objective assessment to replace subjective Glasgow Coma Scale evaluation and demonstrated 100% sensitivity with no false negatives in a preclinical feasibility study (n=100). Has received FDA Breakthrough Device Designation, accelerating the path to FDA clearance.

Quantifiable outcome

• 100% sensitivity with 0 false negatives in pre-clinical feasibility study (n=100)
• +3 more outcomes

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Four partnerships are on record, tiered core and strategic.

• IBM ResearchcoreTechnology or IntegrationLicensing collaboration with IBM Research for use of its metal-oxide semi-conductive (CMOS) compatible nanoscale sensors. The technology enables large-scale production in existing foundries providing scalable and cost-effective manufacturing. Global licensing agreement covers in vitro diagnostics and biosensor fields.
• SkyWater TechnologycoreTechnology or IntegrationPartnership with SkyWater Technology for development and production of nanoscale sensors for rapid COVID-19 testing and other vital diagnostics including TBI, sepsis, and stroke. SkyWater, a semiconductor manufacturer, implemented new manufacturing processes to improve consistency and quality for large-scale distribution.
• Home Base ProgramstrategicStrategic or Co-development PartnerCollaboration with the Home Base Program (Red Sox Foundation and Massachusetts General Hospital) to increase awareness of long-term issues associated with TBI in both active and retired military personnel. Focuses on developing educational programs, special events, public relations, and seeking funding grants.
• Harvard UniversitycoreTechnology or IntegrationLicensed 14 patents from Harvard University covering the company's nanowire technology for in vitro diagnostic and biosensing applications.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Abbott Laboratories: Broad incumbent in point-of-care diagnostics via i-STAT and Alinity platforms. Directly comparable to NanoDx in ED/urgent care POC testing infrastructure and serves the same hospital customers NanoDx targets.
• Siemens Healthineers (POC): Broad POC diagnostics incumbent (epoc, RAPIDPoint, DCA Vantage). NanoDx's CCO Mike Sampson previously led Siemens Healthineers' Global Point of Care business, indicating direct workflow and channel overlap with NanoDx's target ER/urgent care customers.
• Cepheid (Danaher): Molecular diagnostics POC platform (GeneXpert). NanoDx VP Engineering Francisco Dias Lourenco was formerly at Cepheid; the company overlaps with NanoDx in rapid diagnostic workflows targeting emergency and clinical settings.
• bioMérieux (BioFire): Syndromic POC molecular diagnostics via FilmArray/BioFire. Comparable to NanoDx in hospital-based rapid diagnostic panels and multiplexing approach, though BioFire is reagent-PCR-based versus NanoDx's reagentless nano biosensor.
• GenMark Diagnostics (Roche): POC molecular diagnostics ePlex platform now part of Roche. Comparable to NanoDx in multiplexed ED/urgent care testing with cloud-connected instruments delivering rapid results.

Direct peers

• Banyan Biomarkers: Direct blood-based biomarker competitor focused on traumatic brain injury diagnostics (UB-CHM and BTI tests). Most direct comparable to NanoDx's Tbit Test product targeting the same clinical indication and biomarker class.
• QuidelOrtho: Direct POC diagnostics competitor (Sofia, Triage, QuickVue). Comparable to NanoDx in rapid immunoassay-based point-of-care tests distributed into hospitals, urgent care, and physician offices.

Emerging players

• Hound Labs: Emerging POC diagnostics company (marijuana breathalyzer). Comparable to NanoDx as a small-cap handheld diagnostic device company with a recently hired VP Engineering (Francisco Dias Lourenco) overlapping from NanoDx's leadership bench.
• Abionic: Emerging POC diagnostics player using nanofluidic/nanosensor technology for rapid allergy and sepsis testing. Comparable to NanoDx in applying nanotechnology-based biosensing to decentralized clinical diagnostics with multi-analyte panels.
• NephroSant: Emerging diagnostics company developing kidney injury biomarker tests. Comparable to NanoDx as a small biomarker-based diagnostics company where VP Engineering Francisco Dias Lourenco previously worked, with overlapping biomarker assay development capabilities.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/biodirection-inc
• Xx.com/biodirectioninc
• Facebookfacebook.com/biodirection

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles21 records

Funding overview

Funding rounds7 records

Investors3 records

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 NanoDx