Novel Dx — Lab-Quality PCR, Deployable Anywhere

The Problem

Molecular STI testing belongs at the point of care.

Accurate molecular testing for chlamydia, gonorrhea, trichomonas, and Mycoplasma genitalium exists — but it's largely out of reach at the point of care. Most clinics send samples to central labs. Results take days. Patients leave before they are diagnosed, get treated empirically or not at all.

1 in 4

STI-positive patients is never treated — lost to follow-up before send-out lab results return, days after the visit.

Peer-reviewed literature

$16B

Annual direct medical costs from STIs in the US — largely driven by delayed or missed diagnosis at the point of care.

CDC

Rising

Drug-resistant gonorrhea and macrolide-resistant Mycoplasma genitalium are increasing — yet resistance is almost never tested for at the point of care.

CDC / WHO

The Gap

Same-visit STI testing remains out of reach for most clinics.

The vast majority of clinics still rely on send-out labs — meaning results arrive days later, after the patient has already left. Empiric treatment fills the gap, at a cost to patients and to antimicrobial stewardship.

The Resistance Crisis

Gonorrhea and MG are becoming untreatable.

Drug-resistant gonorrhea is a WHO priority pathogen. Macrolide-resistant MG is endemic in many populations. Yet point-of-care platforms today have no ability to detect resistance — clinicians prescribe blind.

The Equity Issue

Much of this burden falls on women.

Chlamydia, gonorrhea, trichomonas, and MG disproportionately affect women — causing pelvic inflammatory disease, infertility, and adverse pregnancy outcomes when left untreated. Making testing fast, accurate, and accessible is as much a women's health and equity issue as a diagnostics one.

Novel Dx closes this gap — a full CT/NG/TV/MG panel with lab-grade PCR accuracy in about 15 minutes, on a portable device that needs no lab infrastructure and only a single sample.

The Solution

Meet Novel Dx

A fully automated, battery-operated, ultraportable PCR system that runs a full CT/NG/TV/MG panel in about 15 minutes — on a single sample, with no lab infrastructure required.

For Research Use Only. Not for use in diagnostic procedures. The Novel Dx System is in development and is not currently available for sale. It is expected to be offered for research use only beginning in Q4 2026. It is not cleared or approved by the FDA and is not available for clinical diagnostic use.

Novel Dx instruments — stackable, field-deployable PCR platform

~15 min

Full sample-to-answer PCR result. Less than one minute of hands-on time.

~5 lbs

Compact form factor (7″ × 6″ × 7″). Fits any countertop, field kit, or mobile unit.

Stackable

Instruments stack for high-throughput clinic settings — run multiple panels simultaneously.

Battery capable

Snap-on rechargeable battery packs. Up to 8 hours or ~30 tests per charge.

6-channel

Real-time fluorescence PCR detection across 6 independent channels simultaneously.

Connected

WiFi + cellular. Cloud-connected for real-time data transmission and EMR integration.

Room-temp stable

Cartridges require no cold chain — store and ship at room temperature.

Affordable

Instrument and cartridges priced for decentralized settings — not hospital lab volumes.

On-Board Extraction

Full-sensitivity PCR from virtually any sample.

The Novel Dx cartridge integrates magnetic bead-based nucleic acid extraction on-board — no external instruments, no pipetting, no sample prep. Full analytical sensitivity is preserved from collection to result.

Compatible Sample Types

Urine Whole Blood Plasma Serum Nasal Swabs Vaginal Swabs Stool Swabs Saliva

Power & Portability

Designed for
the field.

Novel Dx is powered by a snap-on rechargeable battery pack or standard wall outlet. Each pack delivers up to 8 hours of runtime or approximately 30 tests per charge. Carry multiple packs for extended use in remote or resource-limited settings.

Up to 8 hrs or ~30 tests per charge Snap-on battery packs Wall outlet compatible No cold chain Field deployable

Independent Validation

Validated by NIH RADx
at Emory University.

The Novel Dx platform was independently evaluated at Emory University under NIH RADx funding — the US government's Rapid Acceleration of Diagnostics initiative. Performance was assessed on par with or exceeding FDA-cleared laboratory PCR platforms.

Respiratory Panel

External Performance Evaluation at Emory University

An independent external performance evaluation of the Novel Dx RT-PCR platform was conducted at Emory University under NIH RADx funding. The study assessed limits of detection for SARS-CoV-2, Influenza A, Influenza B, and RSV — with performance on par with or exceeding FDA-cleared laboratory PCR platforms across all four targets.

External performance evaluation · Emory University · August 2025 · Funded by NIH RADx

For Research Use Only. Not for use in diagnostic procedures. Performance data described here were generated in a research setting and do not establish clinical performance or support any diagnostic claim.

Request the white paper

How It Works

From sample to result
in about 15 minutes.

Designed for any clinical staff member. No laboratory training required.

Collect the sample

Standard collection using urine, nasal swab, vaginal swab, stool swab, saliva, blood, plasma, or serum. No special tubes or processing equipment required.

~1 min hands-on

Load the cartridge

Transfer sample into the single-use Novel Dx cartridge and insert into the instrument. Room-temperature stable — no cold chain. The system takes it from there: automated magnetic bead extraction and 40-cycle PCR run fully hands-free.

<1 min hands-on

Results — treat in the same visit

Clear results on the touchscreen in about 15 minutes. Automatic transmission via WiFi or cellular to cloud and EMR. Clinicians initiate treatment before the patient leaves.

~15 min total

Clinician loading cartridge into Novel Dx

Clinical & Economic Value

Better outcomes.
Better economics for your clinic.

Treat patients in the same visit

With results in about 15 minutes, clinicians can initiate treatment before the patient leaves — eliminating loss to follow-up and enabling a billable treatment event in the same encounter.

A new recurring revenue stream

Clinics bill insurance directly using established CPT codes — no new billing infrastructure needed. Sites already ordering send-out testing can capture that reimbursement in-house.

No lab infrastructure required

Novel Dx is on the pathway to CLIA waiver — no lab director, no certified space. Battery powered. Room-temperature stable cartridges. Deployable in virtually any setting.

Molecular confirmation, not guesswork

Replace symptom-based empiric prescribing with confirmed PCR results — improving patient outcomes and supporting antimicrobial stewardship.

One instrument. Multiple panels.

A single Novel Dx instrument runs STI, respiratory, and an expanding menu — reducing capital cost and training burden versus multiple single-purpose analyzers.

Validated performance

Independently validated at Emory University under NIH RADx funding. Limits of detection on par with or exceeding FDA-cleared laboratory PCR platforms.

For Research Use Only. Not for use in diagnostic procedures. The Novel Dx System is in development, is not currently available for sale, and is not cleared or approved by the FDA. The benefits described above are anticipated outcomes of the product Novel Microdevices is working towards. They are not claims about a currently available product and would not apply to product supplied for research use only.

About Us

Our story

Novel Microdevices was founded in Baltimore, Maryland with one goal: make lab-quality molecular diagnostics accessible everywhere. Growing up in South India, CEO and co-founder Andrea Pais saw firsthand the need for portable, rapid testing in remote areas sometimes days from the nearest hospital. That vision drove the creation of Novel Dx — a platform that brings the full power of PCR to the point of care, from urgent care clinics to global health posts.

Today, Novel Microdevices is a team of scientists, engineers, and diagnostics veterans working from our City Garage headquarters in Baltimore — developing, validating, and manufacturing the Novel Dx platform for launch. We have been awarded over $11M in competitive non-dilutive funding from the NIH, CARB-X, and state agencies. Novel Microdevices holds 20+ granted patents across 7 international jurisdictions covering the instrument, cartridge, and core PCR technology.

2017

Founded in Baltimore, MD

20+

Patents granted, 7 jurisdictions

$11M+

Non-dilutive competitive awards

Senior Leadership

Andrea Pais, MS EE

CEO & Co-Founder

Co-inventor of the Novel Dx platform. 16+ years in microfluidics, MEMS, and lab-on-a-chip. Driving Novel Microdevices from concept through NIH RADx-funded clinical validation and into commercialization.

Rohan Pais, MS ME/EE

VP Engineering & Co-Founder

Co-inventor of the Novel Dx platform. Leads all instrument hardware, cartridge engineering, and manufacturing capabilities at Novel Microdevices.

Hamdi A. Joda, MBBS PhD

VP Assay Development

Formerly Qiagen and HJF. Leads assay development for all Novel Dx panels — STI, respiratory, and global health targets. Co-inventor of the Novel Dx assay chemistry.

Carlos Aparicio, PhD

Chief Operating Officer

Formerly Danaher, Abbott, and NIH RADx. Leads operations, manufacturing scale-up, and quality systems. Brings deep diagnostics industry experience to Novel Microdevices' path to market.

White Papers

Technical resources

White papers and technical documentation on the Novel Dx platform and assay panels.

White Paper

Novel Dx Respiratory Panel External Performance Evaluation at Emory University

External performance evaluation of the Novel Dx RT-PCR platform for simultaneous detection of SARS-CoV-2, Influenza A/B, and RSV. Conducted at Emory University under NIH RADx funding.

Careers

Join the team.

We're a small, fast-moving team in Baltimore building technology that changes how infectious disease is diagnosed globally. We're looking for scientists, engineers, and operators who want to work on something that matters.

Mission-driven

We're building diagnostics for the settings that have never had them — from urgent care to remote health posts around the world.

Cross-functional by design

Our team spans hardware, assay development, software, regulatory, and commercial. Everyone works close to the instrument.

Baltimore-based

We're headquartered at City Garage in Baltimore — a hub for Maryland's life sciences and medtech community.

Current Openings

Open roles are listed on our jobs board.

View Open Positions →

Don't see the right role? We're always interested in exceptional people.
Send your CV to careers@novelmicrodevices.com

Lab-quality PCR,
deployable anywhere.

Molecular STI testing belongs at the point of care.

Meet Novel Dx

Full-sensitivity PCR from virtually any sample.

Designed for
the field.

Validated by NIH RADx
at Emory University.

From sample to result
in about 15 minutes.

Better outcomes.
Better economics for your clinic.

One platform.
An expanding menu.

Our story

Novel Dx in the press

Technical resources

Join the team.

Your clinical portal.

Ready to bring molecular PCR to your setting?

Lab-quality PCR,deployable anywhere.

Molecular STI testing belongs at the point of care.

Meet Novel Dx

Full-sensitivity PCR from virtually any sample.

Designed forthe field.

Validated by NIH RADxat Emory University.

From sample to resultin about 15 minutes.

Better outcomes.Better economics for your clinic.

One platform.An expanding menu.

Our story

Novel Dx in the press

Technical resources

Join the team.

Your clinical portal.

Ready to bring molecular PCR to your setting?

Lab-quality PCR,
deployable anywhere.

Designed for
the field.

Validated by NIH RADx
at Emory University.

From sample to result
in about 15 minutes.

Better outcomes.
Better economics for your clinic.

One platform.
An expanding menu.