Microsampling

The what

We started with blood and skin.

The microbiopsy device is under development and supplied for research purposes only. This device is not for therapeutic or diagnostic use.

hemaPEN^® is supplied for therapeutic or IVD use in Australia, New Zealand, UK, EU and USA only: ARTG number: 280007; CE mark, general IVD; US FDA number: D410490. Outside of the territories listed above, the hemaPEN is supplied for research purposes only and not for therapeutic or diagnostic use.

The how

Microsampling enables:

• less invasive and pain free collection compared with phlebotomy
• more frequent smaller volumes to be collected
• remote patient testing and is suitable for all patient demographics
• samples to be collected by anyone in any place
• elimination of cold chain transportation
• significant cost savings by reducing collection centre costs, transportation fees, storage costs of samples

“Why do we take so much blood, particularly from the frail when we need so little! It’s unethical.” - Neil Spooner, Spooner Bioanalytical, CPSA Colloquia, 25 October 2017.

Technologies

hemaPEN

hemaPEN^® is a microsampling tool that enables the collection of four volumetrically fixed, accurate and precise, samples from a single source.

hemaPEN exemplifies the advantages of dried blood spot (DBS) micro-sample stability, while addressing the associated limitations of volumetric accuracy, hematocrit effect and sample integrity.

Learn more about hemaPEN

Microbiopsy

While traditional biopsies collect a chunk of skin several millimetres across, this microbiopsy device takes only a very small skin sample, removing the need for anaesthesia and sutures and leaving only a pinprick-like wound behind.

"It takes only a quarter of a millimetre of skin – or 1,500 cells – for molecular diagnosis, which eliminates the unnecessary excision of suspicious benign lesions and alleviates the fear of excisions that many people have in the diagnostic process." - Professor H Peter Soyer

More information at Minimizing trauma of skin biopsies - Trajan and UniQuest to form partnership for the commercialization and continued development of devices for microsampling human tissue.

The microbiopsy device is under development and supplied for research purposes only. This device is not for therapeutic or diagnostic use.

hemaPEN^® is supplied for therapeutic or IVD use in Australia, New Zealand, UK, EU and USA only: ARTG number: 280007; CE mark, general IVD; US FDA number: D410490. Outside of the territories listed above, the hemaPEN is supplied for research purposes only and not for therapeutic or diagnostic use.

Applications

• Clinical trials
• Therapeutic drug monitoring
• Skin cancer detection

Complete solutions in microsampling

Pipeline of technology for potential integration

hemaPEN has been designed to effectively integrate with laboratory workflows:

• Pre-punch standard DBS substrate (PKI 226^™, Whatman 903^®) integrates into existing DBS analytical workflows
• Cartridge design integrates with standard microtitre plate formats
• Cartridge design enables integration of customisable or multiple substrates

Trajan is building a suite of technologies and solutions around hemaPEN as a platform technology that can be applied to any microsampling workflow challenge:

• Synthetic substrates that can be functionalized to improve sample stability, reduce ubiquitous impurities of standard cellulose-based DBS papers, or streamline sample extraction
• Customizable cartridge design
• Custom analytical workflow integration or automation solutions

Partner in vertically integrated solutions

• Design and development of components
• Manufacturing and global distribution
• Design and assembly of blood sampling kits
• Laboratory workflow integration solutions
• Analytical testing services
• Global sales and marketing

226™ is a trademark of PerkinElmer, Inc or its affiliated entities. 903^® is a registered trademark of Eastern Business Forms, Inc.

Our collaborators

ASTech

We are working with ASTech - ARC Training Centre for Portable Analytical Separation Technologies on hemaPEN and sample separation.

UniQuest, University of Queensland

We are working with UniQuest, University of Queensland (UQ) to develop and commercialize devices for microsampling human tissue.

More information about UQ Dermatology Research Centre.

Future Industries Institute, University of South Australia

We are working with the Future Industries Institute (FII) at University of South Australia (UniSA) on microbiopsy development.

Design + Industry

Trajan collaborated with D+I (Design + Industry) in the development of hemaPEN^® from initial concepts to prototype device for research and investigational use.

Spooner Bioanalytical Solutions

Spooner Bioanalytical Solutions is consulting to Trajan by way of providing expert review, advice and opinion in the area of microsampling.

Coverage

• CE mark for Trajan’s hemaPEN blood microsampling device, now available for diagnostic use across EU and UK
• The third leg in at-home healthcare – microsampling
• Trajan’s hemaPEN included on TGA’s ARTG as first blood microsampling device for use in Australia
• Pens and prospering as a manufacturer
• Minimizing trauma of skin biopsies - Trajan and UniQuest to form partnership for the commercialization and continued development of devices for microsampling human tissue
• AusBiotech Dispatch - Trajan teams up with UniQuest

Weekly, do-it-yourself blood samples are being pushed as the future of preventative medicine by the Melbourne minds behind the hemaPEN. @msanto92 #9News pic.twitter.com/w4tYPleIYJ

— Nine News Melbourne (@9NewsMelb) April 17, 2019

Resources

• hemaPEN resources