What Novel Microdevices does

Novel Microdevices, Inc. (operating as Novel DX / Novel Dx) is a privately held, woman-owned medical device company founded in 2015 in Baltimore, Maryland by CEO Andrea Pais and VP of Engineering Rohan Pais. The company is developing a portable, battery-powered, under-4-pound point-of-care molecular diagnostic system that performs RT-PCR and isothermal Nucleic Acid Amplification Tests (NAAT) on disposable microfluidic cartridges, delivering lab-quality results in approximately 15 minutes. The product targets women's health, under-resourced populations, and infectious disease diagnostics in clinical and low-resource settings, with an assay menu that includes multiplex respiratory pathogens (RSV, Influenza A/B, COVID-19) and sexually transmitted infections including Chlamydia trachomatis, Neisseria gonorrhoeae, and antibiotic-resistant gonorrhea strains. The platform is designed for CLIA waiver eligibility, enabling use outside traditional laboratories.

The company's revenue model centers on sales of the Novel Dx instrument and proprietary disposable assay cartridges, with planned direct enterprise sales to healthcare providers, hospitals, clinics, and point-of-care settings. As of the most recent company materials, the Novel Dx System and Diagnostic Assays are explicitly stated as "in development and not available for sale," placing the company in a pre-commercial stage. The company has funded operations almost entirely through non-dilutive grants and awards, including up to $13.8 million from CARB-X (2021), $1.4 million Phase 1 and $2.68 million follow-on from NIH RADx Tech (2023 and 2024), $500,000 from TEDCO (2025), and $633,757 from the Maryland Department of Commerce Build Our Future Grant (2025) to establish a GMP-compliant pilot manufacturing facility at the Baltimore headquarters. The device is also cloud-connected (Novel Dx Cloud) with a customer portal (My Novel DX), and is positioned as stackable for throughput scaling in clinical workflows.

Name

Novel Microdevices

Legal name

Novel Microdevices, Inc.

Website

https://noveldx.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Novel Microdevices is a Baltimore-based medical device company developing a portable, battery-powered point-of-care RT-PCR molecular diagnostic system (Novel Dx) that delivers lab-quality results in approximately 15 minutes on disposable microfluidic cartridges, targeting infectious disease testing — including respiratory pathogens and sexually transmitted infections — for women's health, underserved, and low-resource settings.

Ownership category

akta.pro rank

Product category

Point-of-Care Molecular Diagnostics

NAICS

Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Laboratory Automation, Sample Prep & Liquid Handling (IVD Lab Diagnostics) (HLAHAAAN)

akta.pro secondary industries

Molecular Biology & Genomics Instruments (PCR/qPCR, Sequencing, Microarrays) (HLAGAIAF), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL), Microbiology & Infectious Disease Diagnostics (Culture/ID/AST) (HLAHAAAC)

Keywords

• Point-of-care diagnostics
• Molecular diagnostic devices
• RT-PCR testing
• Microfluidic cartridges
• Infectious disease detection

Headquarters

HQ city

Baltimore

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, Supply Chain, Operations, Infrastructure

Revenue model

1. Novel Dx Diagnostic System Sales: The company generates revenue from sales of its Novel Dx point-of-care RT-PCR diagnostic device and associated disposable cartridges. The system detects respiratory viruses and STIs in approximately 15 minutes at the point of care.
2. Molecular Diagnostic Assays: Revenue from proprietary assay tests for infectious disease detection including respiratory infections (Flu, RSV, COVID-19) and sexually transmitted infections (STIs).

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Novel Microdevices develops and is commercializing the Novel Dx system, a portable, battery-powered point-of-care RT-PCR molecular diagnostic platform weighing under 4 pounds. The system uses disposable microfluidic cartridges to perform automated sample-to-answer nucleic acid amplification testing, delivering lab-quality results in under 15 minutes for respiratory infections (Flu, RSV, COVID-19) and sexually transmitted infections including antibiotic-resistant gonorrhea.

Product overview

Novel Microdevices commercializes Novel Dx, a proprietary point-of-care rapid molecular diagnostics system consisting of a portable hardware device (Novel Dx System) and disposable diagnostic assay cartridges. The system uses RT-PCR technology on microfluidic cartridges to deliver lab-quality results in under 15 minutes at the point of care. The product portfolio includes multiplex respiratory infection assays (Flu, RSV, COVID-19) and sexually transmitted infection tests (STIs), with the STI test specifically targeting antibiotic-resistant pathogens. The system is designed for portability (under 4 lbs, battery-powered), enabling use in low-resource settings and low-and middle-income countries.

Differentiator

Problem solved

Functional benefit

Brands

• Novel Dx System: A portable, battery-powered, point-of-care RT-PCR diagnostic platform that provides lab-quality results in under 15 minutes.
• My Novel DX

Products and services

• Novel Dx System Portable, battery-powered point-of-care RT-PCR diagnostic platform weighing under 4 pounds, designed for CLIA waiver to enable use outside traditional laboratory settings. Runs disposable microfluidic cartridges that automate sample lysis, nucleic acid extraction, and PCR amplification for infectious disease detection.
• Novel Dx Respiratory Diagnostic Assays

Quantifiable outcome

• 15-minute time-to-result vs. days for traditional lab testing
• +3 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Abbott (ID NOW):
• Cepheid (Danaher): Cepheid's GeneXpert system is the established point-of-care RT-PCR platform with CLIA-waived Xpress assays (e.g., Xpress Flu/RSV, Xpress CT/NG, Xpress SARS-CoV-2). Most directly comparable on multiplexing, time-to-result (~30 min for Xpress), and menu breadth, and dominates the POC molecular space Novel Microdevices is targeting.
• bioMérieux (BioFire): BioFire FilmArray platforms (including the CLIA-waived SpotFire) deliver multiplex PCR results in ~15-20 minutes at the point of care. Directly comparable on platform architecture, time-to-result, and respiratory / STI panel strategy; BioFire is a leading incumbent in hospital POC molecular diagnostics.

Market position

Strengths1 record

Weaknesses1 record

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/noveldx

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds8 records

Investors4 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 Novel Microdevices