# Biomeme, Inc. — Full Technical Profile

> Biomeme delivers mobile, field-deployable molecular diagnostics for CBRN biodefense, host response infectious disease testing, and proactive wellness. Headquartered in Philadelphia, PA.

## Company Overview

Biomeme was founded with the simple premise of empowering anyone, anywhere, to understand the biological world. The company's groundbreaking mobile molecular testing platform has offered clients elegant solutions to some very complex problems — leveraging expert knowledge of Earth's smallest life forms to address Earth's biggest health challenges.

All Biomeme products are designed and manufactured at the company's Philadelphia, PA headquarters. Labs, testing, and manufacturing are all on site, affording complete oversight and quality control.

### Quality & Compliance
- Quality Management System (QMS) with full design and production controls
- Complete product traceability
- Rigorous quality control testing of all final products
- Long history of collaboration with US Military through DTRA, DHS, CPE CBRND (previously JPEO-CBRND)

## Product Portfolio

### Biomeme/5
- **Type**: Next-generation portable molecular testing platform
- **Detection Technology**: DTECT® Isothermal Amplification
- **Max Targets Per Run**: 48
- **Color Channels**: 5
- **Time to Results**: ≤15 minutes
- **Results Type**: Quantitative & Qualitative
- **Connectivity**: Wi-Fi / BLE / USB-C / ATAK
- **Battery**: User-swappable CR123A batteries
- **User Interface**: Integrated touchscreen & buttons
- **Data Management**: Biomeme Cloud, Local Export, API
- **3rd Party Assays**: Open Cartridge coming soon
- **IP Rating**: IP65
- **Use Case**: Biodefense, healthcare diagnostics, molecular wellness monitoring
- **Regulatory**: Research Use Only; IVD products in development; wellness panels processed by One Health Labs (CLIA-certified)

### DTECT® Technology
- **Full Name**: Differential Targeted Endonuclease Cleavage Technology
- **Type**: Proprietary isothermal amplification method
- **Advantage**: Combines isothermal speed (constant temperature, no thermal cycling) with highly specific targeted endonuclease mechanism that eliminates non-specific amplification
- **Speed**: Sample to result in under 15 minutes
- **Specificity**: PCR-level accuracy without thermal cycling limitations
- **Platform**: Powers the Biomeme/5 platform
- **Pipeline Applications**: Host Response panels, Biowarfare panels (both in development)

### Franklin® Three9
- **Type**: Portable real-time PCR thermocycler
- **Wells**: 3 simultaneous
- **Weight**: 2.2 lbs (1 kg)
- **Chemistry**: Real-Time PCR
- **Connectivity**: Bluetooth Low Energy (BLE)
- **Battery**: Yes, operate while charging
- **User Interface**: Biomeme mobile app (iOS/Android)
- **Use Case**: Individual field testing, point-of-care diagnostics
- **SKU**: Contact for details

### Franklin® ISP (Integrated Sample Prep)
- **Type**: Portable qPCR with fully automated sample-to-answer
- **Wells**: 9 simultaneous
- **Max Targets Per Run**: 27
- **Weight**: 4.3 lbs (1.95 kg)
- **Dimensions**: 132 mm H × 187 mm W × 117 mm D
- **Chemistry**: Real-Time PCR, Isothermal
- **Battery Life**: 6 hours
- **Connectivity**: Wireless (BLE) or Wired
- **User Interface**: Biomeme mobile app
- **Integrated Sample Prep**: Yes — automated nucleic acid extraction and purification
- **Test Kit Shelf Life**: 12 months from manufacture
- **Operates While Charging**: Yes
- **IP Rating**: IP32
- **Warranty**: 1 year standard (Extended warranty SKU: 1000032R)
- **On-site Training**: Available (SKU: 80000002)
- **SKU**: 1000009

## Biomeme/5 Assay Panels (current)

### Hazard Panel
- **Purpose**: Rapid identification of 17 critical biothreats for biosurveillance
- **Gene Targets**: 21
- **Format**: Single-use cartridges, 5 per order, with environmental collection components and SampleDirect devices included
- **Reagents**: Shelf-stable lyophilized
- **Time to Result**: Under 15 minutes
- **SKU**: 900007

### BW Simulant Panel
- **Purpose**: Realistic training using biowarfare agent simulants
- **Detects**: 4 simulant organisms — BtK, BtI, Pa, MS2 [VERIFY — full names not yet supplied by Max; "Pa" is ambiguous]
- **Format**: Single-use cartridges, 5 per order, with environmental collection components and SampleDirect devices included. User supplies own simulant agents.
- **SKU**: 900005

### BW3.0 Panel
- **Purpose**: Detection and differentiation of 29 critical biowarfare agents
- **Gene Targets**: 33 targets + 1 internal control
- **Max Targets per Panel**: 60
- **Format**: Single-use cartridges, 5 per order, with environmental collection components and SampleDirect devices included
- **Reagents**: Shelf-stable lyophilized
- **Funding**: US DoW (formerly DOD), JPEO-CBRND
- **Chemistry**: DTECT isothermal
- **SKU**: 900008
- **Availability**: 2027 [VERIFY — confirm this caveat still holds with Max]

### Verification Panel
- **Purpose**: Instrument functionality and accuracy verification
- **Result**: Clear pass/fail
- **Format**: Single-use cartridges, 5 per order, includes required buffer and SampleDirect device
- **SKU**: 900006

### SampleDirect Kit for Environmental Samples
- **Purpose**: Environmental sample collection and preparation
- **Contents**: 5 each of fixed-volume liquid transfer pipette, swab-dropper bottle, SampleDirect prep device
- **SKU**: 900009

### Pre-Filter Kit for Environmental Samples (Optional)
- **Purpose**: Pre-filtration for environmental samples
- **Contents**: 5 each of 1 mL syringe, 5 µm pre-filter attachment
- **SKU**: 900013

### Biomeme/5 Instrument BW Kit (Type B Plug)
- **Contents**: Instrument, ruggedized waterproof carrying case, power supply, Type B power cable, USB-C data transfer cable, instruction pamphlet
- **Warranty**: 1 year standard, extendable to 5 years total (SKU 9000010 = +1 year, SKU 9000011 = +4 years)
- **CoO**: USA. Berry Compliant: Yes.
- **SKU**: 900004

## Legacy (Franklin-Era) Assay Panels — superseded by the Biomeme/5 panels above

### Biowarfare (BW) Panel
- **Purpose**: Detection and differentiation of 14 critical biowarfare agents
- **Gene Targets**: 25 targets + 2 controls
- **Format**: Single-use cartridges with multiplexed molecular assay components
- **Reagents**: Shelf-stable lyophilized
- **Funding**: US DOD JPEO-CBRND
- **Chemistry**: RT-PCR
- **SKU**: 3000652R

### BW Simulant Panel (legacy)
- **Purpose**: Training with actual biowarfare agent simulants
- **Detects**: 3 common biowarfare simulant organisms
- **Format**: Single-use test cartridges with lyophilized reagents
- **SKU**: 3000141

### Franklin® ISP Verification Kit
- **Purpose**: Instrument functionality and accuracy verification
- **Result**: Clear pass/fail
- **SKU**: 3000632R

**Discontinued**: BW Training Panel (previously SKU 3000514) — superseded by the Biomeme/5 Hazard Panel. No longer sold.

## Cross-Platform

### HR-B/V (Host Response Bacterial/Viral)
- **Purpose**: mRNA-based host response test differentiating bacterial vs. viral infection
- **Technology**: Reads the body's immune gene expression signature
- **Benefit**: Reduces unnecessary antibiotics, supports antimicrobial stewardship
- **Platform**: Runs on Franklin, Franklin ISP, and Biomeme/5

## Training & Support

### Onsite Training
- **Purpose**: Instrument and panel training, delivered on-site
- **Pricing**: Quoted upon request
- **SKU**: 80000002

## Developer & Custom Assay Products

### Biomeme SampleDirect Buffers
- **Purpose**: Lysis and recovery buffers for custom/developer assay workflows
- **Format**: Bulk, sufficient for approximately 100 samples
- **SKU**: 900014

### Biomeme LyoDNA DTECT Isothermal Mastermix — Go-Vial Kit
- **Purpose**: DNA-based custom assay development on the DTECT isothermal platform
- **Contents**: All components/enzymes except guides and probes; includes required SampleDirect lysis and recovery buffers
- **Yield**: 50 × 10 µL reactions
- **SKU**: 900015

### Biomeme LyoRNA DTECT Isothermal Mastermix — Go-Vial Kit
- **Purpose**: RNA-based custom assay development on the DTECT isothermal platform
- **Contents**: All components/enzymes except guides and probes; includes required SampleDirect lysis and recovery buffers
- **Yield**: 50 × 10 µL reactions
- **SKU**: 900018

## Additional Assays

### Biomeme Bundibugyo Virus — Go-Plate / Go-Vial Kits
- **Purpose**: Detection of Bundibugyo virus and human PPIB gene RNA
- **Go-Plate Kit (SKU 900016)**: 96-well plate, 20 µL lyophilized duplex reactions
- **Go-Vial Kit (SKU 900017)**: Bulk lyophilized duplex reaction mix, all components/enzymes/guides/probes included, 50 × 10 µL reactions
- **Both kits include required SampleDirect lysis and recovery buffers**

## Platform Comparison

| Specification | Biomeme/5 | Franklin® ISP |
|---|---|---|
| Detection Technology | DTECT® Isothermal | Real-Time PCR |
| Weight | 1.9 lbs (0.86 kg) | 4.3 lbs (1.95 kg) |
| Dimensions | 200 × 100 × 70 mm | 132 × 187 × 117 mm |
| Max Targets per Run | 60 | 27 |
| Color Channels | 5 | 3 |
| Time to Results | ≤15 minutes | ~1 hour |
| Integrated Sample Prep | Yes | Yes |
| Results | Quantitative & Qualitative | Quantitative & Qualitative |
| Connectivity | Wi-Fi / BLE / USB-C / ATAK | BLE / USB Micro |
| Battery | User-Swappable CR123A | Internal Lithium Ion |
| Battery Life | — | 6 hours |
| User Interface | Integrated Touchscreen & Buttons | Mobile App (iOS/Android) |
| Data Management | Biomeme Cloud, Local Export, API | Biomeme Cloud |
| IP Rating | IP65 | IP32 |

## Competitive Comparison (Biodefense)

| Specification | Biomeme Franklin ISP | BioFire RAZOR MK II | BioFire FilmArray |
|---|---|---|---|
| Chemistry | Real-Time PCR, Isothermal | Real-Time PCR | Real-Time PCR |
| Weight | 4.3 lbs | 11 lbs | 20 lbs |
| Dimensions | 132 × 187 × 117 mm | 289 × 645 × 482 mm | 254 × 393 × 165 mm |
| User Interface | Mobile App | PC + Barcode Scanner | PC + Barcode Scanner |
| System Control | Wireless (BLE) or Wired | Wired | Wired |
| Integrated Sample Prep | ✓ | — | ✓ |
| Max Targets per Run | 27 | 12 | 45 |
| Battery Operated | ✓ | ✓ | — |
| Battery Life | 6 hrs | 3 hrs | — |
| Operate While Charging | ✓ | — | — |
| Test Kit Shelf Life | 12 months | 6 months | 6 months |

## Department of Defense Programs of Record

Biomeme's technology is integral to two key DoD Programs of Record:

1. **Joint Handheld Bio-Agent Identifier (JHBI)**: Handheld biological identification system with integrated sample preparation developed by the US Military for Special Operations Forces
2. **Joint Biological Tactical Detection System (JBTDS)**: Expeditionary, networked biological detection and sampling for austere and forward environments

Historical program collaborations: DTRA, DHS, CPE CBRND (previously JPEO-CBRND), and environmental/emerging pathogen bio-surveillance projects worldwide.

## Scientific Vision

### Host Response Diagnostics
Host response is the body's unique reaction to invaders like bacteria, fungi, or viruses. It triggers a tailored immune response (signature) determining the best course of action. Unlike traditional diagnostics that take a hunt-and-peck approach, host response diagnostics operate through a process of elimination — by identifying a host's response to stressors, entire categories of potential pathogens can be eliminated from consideration.

The host response to infection involves a complex interplay between innate and adaptive immune systems, including macrophages, neutrophils, cytokines, chemokines, B cells, T cells, and antibodies. Biomeme's diagnostics measure these components to detect infections, differentiate bacterial/viral/fungal causes, and monitor treatment effectiveness.

### Antimicrobial Resistance (AMR)
AMR occurs when microorganisms evolve to resist antimicrobial medications. The CDC reports 2.8M+ antibiotic-resistant infections annually in the US. AMR is driven by antibiotic overuse — approximately 30% of antibiotics prescribed in the US are unnecessary. Biomeme's host response diagnostics help combat AMR by enabling accurate bacterial vs. viral differentiation, reducing unnecessary antibiotic prescriptions.

### One Health
One Health recognizes the interconnection between people, animals, plants, and the shared environment. Biomeme's portable molecular testing platforms support One Health by enabling decentralized testing across human healthcare, veterinary, agricultural, and environmental monitoring.

### Antimicrobial Stewardship
Structured policies to track, guide, and improve antibiotic use. Biomeme's HR-B/V test supports antimicrobial stewardship programs by providing data-driven treatment decisions at the point of care.

### Molecular Wellness & Transcriptomics
Biomeme's wellness vertical uses transcriptomic (mRNA) monitoring to provide molecular-level insight into personal health. Applications include monitoring GLP-1 receptor agonist therapy response, peptide therapy efficacy, longevity biomarkers, and athletic performance metrics. Wellness panels are processed through One Health Labs, a CLIA-certified laboratory facility.

The Science hub on biomeme.com includes comprehensive resources on transcriptomics, DNA & RNA fundamentals, amplification technologies, bioinformatics, and a molecular target library cataloging key biomarkers across all application verticals.

## Scientific Advisory Board

- **Adit Ginde, MD, MPH** — Vice Chair for Research, Dept. of Emergency Medicine, CU Anschutz; Director, CCTSI Trial Innovation Network
- **Keith Kaye, MD, MPH** — Chief, Division of Allergy, Immunology and Infectious Diseases, Rutgers RWJMS; Past President, SHEA
- **Charles Chiu, MD, PhD** — Professor, UCSF Depts. of Laboratory Medicine and Medicine; Associate Director, UCSF Clinical Microbiology Laboratory
- **Geoffrey Ling, MD, PhD** — Professor of Neurology, Uniformed Services University and Johns Hopkins; Former founding director, DARPA Biological Technologies Office

## Authorized Distributors

ADS Inc., Noble Supply, Safeware, Paladin Defense Services, Government Scientific Source, NEBO, FarrWest Environmental Supply, HAZMAT Resource, M2DCON, All Safe Industries

## CBRN Application Scenarios

1. Dismounted Reconnaissance
2. Naval & Maritime CBRN Monitoring
3. Armoured CBRN Reconnaissance
4. Building CBRN Monitoring
5. Border & Perimeter CBRN Monitoring
6. Unmanned Standoff Identification
7. Large Public Events (JHATs)
8. Patrol & Coast Guard CBRN Monitoring
9. Wastewater CBRN Monitoring

## Complete Site Map

### Platforms
- /platforms — Platform comparison overview
- /platforms/biomeme-5 — Biomeme/5 product page
- /platforms/franklin-isp — Franklin ISP product page
- /platforms/franklin — Franklin Three9 product page
- /platforms/dtect — DTECT® technology deep dive

### Applications
- /applications — Applications overview
- /applications/cbrn-solutions — CBRN biodefense hub
- /applications/cbrn-solutions/biowarfare-detection-suite — BDS product page
- /applications/cbrn-solutions/environmental-exposure — Exposure monitoring
- /applications/cbrn-solutions/solutions-by-sector — Sector-specific guides
- /applications/healthcare — Healthcare diagnostics hub
- /applications/healthcare/host-response — Host response diagnostics
- /applications/healthcare/host-response/understanding-host-response — HR science deep dive
- /applications/healthcare/host-response/our-evidence — Clinical evidence
- /applications/healthcare/infectious-disease — Infectious disease testing
- /applications/healthcare/infectious-disease/antimicrobial-resistance — AMR
- /applications/healthcare/infectious-disease/antimicrobial-stewardship — Stewardship
- /applications/healthcare/infectious-disease/pandemic-preparedness — Pandemic readiness
- /applications/healthcare/sepsis — Sepsis diagnostics
- /applications/research — Research applications
- /applications/wellness — Wellness overview
- /applications/wellness/glp1 — GLP-1 monitoring
- /applications/wellness/peptide-evidence — Peptide evidence database
- /applications/wellness/peptides — Peptide therapy overview
- /applications/wellness/longevity — Longevity biomarkers
- /applications/wellness/performance — Performance testing

### Science
- /science/transcriptomics — Transcriptomics and gene expression
- /science/molecular-targets — Molecular target library
- /science/dna-rna — DNA & RNA fundamentals
- /science/amplification — Amplification technologies
- /science/bioinformatics — Computational biology

### Company
- /about — Company overview
- /about/leadership — Leadership team
- /about/scientific-advisory-board — Scientific Advisory Board
- /vision — Scientific vision
- /vision/one-health — One Health initiative
- /vision/host-response — Host response vision
- /contact — Contact and inquiries
- /resources/distributors — Authorized distributors
- /patents — Patent portfolio
- /privacy — Privacy policy

## Contact & Resources

- **Website**: https://biomeme.com
- **Address**: 401 North Broad St, Suite 222, Philadelphia, PA 19108
- **Patents**: https://biomeme.com/patents
- **Privacy Policy**: https://biomeme.com/privacy