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New tissue acquisition tools for gene expression
analysisTissue quality and patient comfort
Prof. Jaak Ph. Janssens MD, PhD
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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
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Bench Tissue acquistion BedReimbursementPharmaceutical Industry
BurdenInstitutionTradition…
Obstacles for translational research
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Bench Tissue acquistionRepresentativityPatient comfortCostsAccess
Bed
ReimbursementPharmaceutical Industry
BurdenInstitutionTradition…
Obstacles for translational research
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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
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Tissue acquisition quality problem
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Fine needle aspiration (Cytology)
Microbiopsy (16 to 14 Gauge)
Macrobiopsy (8 to 12 Gauge)
Open biopsy (general anaesthesia)
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Representativity 98 % complete true prediction rate (compared to surgery)
False negative prediction rate < 1 %Transplantation quality150 to 300 mg samples
Patient comfort No pain (compared to mammography)No complications (requiring additional medical interventions)
Reduced scarringCosts 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)
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Tru-cut D & F VAB SurgeryRepresentativity No Yes Yes YesComfort Yes Yes No NoCosts Yes Yes No NoAccess Yes Yes No Yes
Tissue acquisition for translational research
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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
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Conclusion
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Clinical Study & Advisory GroupRüdiger Shulz-Wendtland Erlangen – GermanyLuc Rotenberg Paris – FrancePino Cusumano Liège – BelgiumRichard Harries Grimsby – UKWoijtek Polkowski Lublin – PolandGaston Mendoza Lima – PeruMelcior Sentis Barcelona – SpainJohannes Bogers Antwerp - Belgium
Thank you.
