1

New tissue acquisition tools for gene expression

analysis

Tissue quality and patient comfort

Prof. Jaak Ph. Janssens MD, PhD

2

Molecular biology research◦ PCR, microchips, ◦ Proteomics, genomics,…◦ Mutation research, polymorphisms

Screening◦ Risk biomarkers

Diagnosis◦ Fine tuning and reclassification

Personalized therapy◦ Prognostic markers◦ Pathway analysis – response prediction

Translational Research

3

Bench Tissue acquistion BedReimbursement

Pharmaceutical Industry

Burden

Institution

Tradition…

Obstacles for translational research

4

Bench Tissue acquistionRepresentativityPatient comfortCostsAccess

Bed

Reimbursement

Pharmaceutical Industry

Burden

Institution

Tradition…

Obstacles for translational research

5

Tissue quality◦ Representative ◦ One large piece of tissue ◦ No artifacts

Patient comfort◦ No pain, no complication risk = safe

Inexpensive Access

◦ Handsome◦ Fast – minimal personnel◦ No dedicated room

Requirements for tissue acquistion related to translational research

6

Tissue acquisition quality problem

7

Fine needle aspiration (Cytology)

Microbiopsy (16 to 14 Gauge)

Macrobiopsy (8 to 12 Gauge)

Open biopsy (general anaesthesia)

8

9

Representativity 98 % complete true prediction rate (compared to surgery)

False negative prediction rate < 1 %

Transplantation quality

150 to 300 mg samples

Patient comfort No pain (compared to mammography)

No complications (requiring additional medical interventions)

Reduced scarring

Costs Range 10 – 150 Euro (compared to 250 to 350 Euro)

Access Kits ready to start (compared to set-up times of > 30 min)

No decicated rooms

Results from safety and efficacy trials (n = 300 patients)

10

Tru-cut D & F VAB Surgery

Representativity No Yes Yes Yes

Comfort Yes Yes No No

Costs Yes Yes No No

Access Yes Yes No Yes

Tissue acquisition for translational research

11

12

13

14

15

Medinvents’ Products

• Automated version • Handheld or stereotactically positioned• Reusable handle controller, disposable

8 – 10 Gauge needles• Vacuum assisted system• Multiple samples without reinserting

• A range of large core soft tissue biopsy needles• Based on NEW double rota-cutting technique• 8 – 14 Gauge• Vacuum system on Single Use

Product portfolio:• Spirotome Single Use/Reusable• Spirotome Cervicore ™• Spirotome MRI ™• Spirotome Bone ™• Spirotome Easy Punch ™

Medinvents’ ApplicationsCoramate ™•Breast•Thyroid•Salivary glands•Thoracic wall•Abdominal wall•Lymph nodes•Muscle

Spirotome™•Breast•Thyroid•Salivary glands•Thoracic wall•Abdominal wall•Lymph nodes•Muscle•Liver

Spirotome Cervicore ™•Cervix•Uterus

Spirotome Easy Punch ™•Skin•Vulva

Spirotome Bone ™•Soft tissues within bone

18

Conclusion

19

Clinical Study & Advisory Group

Rüdiger Shulz-Wendtland Erlangen – Germany

Luc Rotenberg Paris – France

Pino Cusumano Liège – Belgium

Richard Harries Grimsby – UK

Woijtek Polkowski Lublin – Poland

Gaston Mendoza Lima – Peru

Melcior Sentis Barcelona – Spain

Johannes Bogers Antwerp - Belgium

Thank you.