THE PROBLEM
13M global deaths annually from infectious diseases.
People lack access to affordable, accurate, rapid diagnostic testing.
PCR is the global gold-standard for detecting infections and guiding containment and treatment. Despite its importance, PCR testing remains stuck in the lab, making it slow, costly, and inaccessible to nearly 47% of the world’s population*.
*Fleming KA et al., The Lancet Commission on Diagnostics: Transforming Access to Diagnostics, published in The Lancet (2021)
WHY PCR REMAINS STUCK IN THE LAB
Despite advances in portability, existing PCR devices still rely on traditional extraction workflows, instrument-dependent processes, and controlled lab-like environments. Some portable systems have made it into clinics, but they have not eliminated the core barriers: purification steps, inhibitory sample media, cost, and workflow complexity.
As a result, point-of-care PCR systems that rely on extraction remain costly and difficult to scale, and most PCR testing is still confined to centralized or near-centralized labs.
OUR TECHNOLOGY
Patented Breakthrough Extraction-Free PCR
Our patented direct-to-PCR technology eliminates the key barriers that limit traditional PCR workflows. By removing the need for sample purification, overcoming inhibitory media, and enabling high-performance amplification directly after collection, we enable PCR testing that is faster, simpler, and broadly accessible. Our chemistry can be integrated into existing PCR workflows or future point-of-care systems, removing the extraction bottleneck that has limited where PCR can be used. Our goal is to democratize PCR so accurate diagnostics can be delivered @ANYWHERE™.
Compared to conventional PCR:
7x faster turnaround times
7x lower cost average across test types
Highly accurate results
COMPETITIVE ADVANTAGE
Our patented extraction-free chemistry eliminates key barriers that limit traditional PCR workflows. By removing the need for sample purification and enabling high-performance amplification directly from swabs and saliva, our technology delivers accurate, rapid, and scalable PCR testing across platforms.
Key differentiators include:
- Extraction-free performance proven across clinical and research sample types
- Direct amplification from raw swabs and saliva, without purification
- Non-inhibitory formulation designed to support direct-to-PCR amplification
- Broad platform compatibility with existing laboratory PCR systems and future point-of-care solutions
- Patent-backed coposition-of-matter and methods claims (one issued, five pending)
This combination positions Transformative Biotech as a foundational enabler for next-generation molecular diagnostics.
Competitive Comparison
Our Chemistry
✓ Extraction-free
✓ Non-inhibitory formulation
✓ Works with swabs and saliva
✓ Compatible with standard PCR systems
✓ Patent-backed (1 issued, 5 pending)
Traditional PCR / Other Media
✗ Requires extraction
✗ Contains PCR inhibitors
✗ Limited saliva performance
✗ Lab-dependent workflows
✗ Fragmented IP landscape
Traction
Our technology is supported by strong clinical experience, real-world operational use, and a substantial IP foundation.
Clinical validation
- Clinically validated extraction-free PCR for COVID-19 using swab and saliva samples
- Demonstrated clinical equivalence to traditional extraction-based PCR in high-volume testing
R&D validation across additional pathogens
- Proof-of-concept studies for respiratory pathogens and STIs (CT/NG)
- Consistent extraction-free performance observed in R&D settings
- Not yet clinically deployed beyond COVID-19
Operational and commercial traction
- 590,000+ clinical samples tested using extraction-free workflows
- $14M in commercial revenue generated through extraction-free testing (Summit Biolabs)
- Exclusive, co-owned IP estate with one issued patent and five pending
TEAM
Core Team
Our team brings decades of experience across diagnostics, molecular biology, and early-stage commercialization, with a track record of developing and scaling technologies in startup settings.
SP NOTE TO SELF: look into the team functionality, I don’t think it works particularly well for this one-page layout but has the linkedin icon that maybe I can add below name, title?
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Advisors & Collaborators
We collaborate with leading experts across diagnostics, engineering, and infectious diseases.
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CONTACT US
SP NOTE TO SELF: Need to talk to the designer (Andy? look it up) for how to work these options in this builder. Also the footer needs redone.
SP NOTE TO SELF: Is there another contact form I can use other than this porto one? or can i redesign it?
