A Disruptive Approach.

Transcription

1 1 Taking Control of Fixation for Improved IHC. A Disruptive Approach. 2

2 ASCO/CAP Recommendations for HER2 Results: Approx. 20% of current HER2 testing may be inaccurate What can be done? ASCO/CAP Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer,Arch Pathol Lab Med-Vol 131, January The case of fixation for HER2 Time for tissue acquisition to fixation should be as short as possible Samples should be sliced at 5-10 mm intervals. Placed in sufficient volume of neutral buffer formalin.. Time to fixation and duration of fixation if available should be recorded for each sample. Fixation for fewer than 6 hours or longer than 48 hours is not recommended. ASCO/CAP Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer,Arch Pathol Lab Med-Vol 131, January

3 20 th Century pre-analytical techniques Handling/transfer of biospecimens Grossing Fixation Limited standardization/documentation 5 21 st Century analytical techniques IHC Molecular Studies Standardized and documented protocols 6

4 Equivalent to 20 octane fuel for a Ferrari The car s potential will never be achieved 7 Advancing the pre-analytical step to the 21 st century Milestone evidence-based chain of custody for biospecimens, from the patient body to the histology lab 8

5 Milestone evidence-based chain of custody 9 Through standardized/documented: Handling/Transfer of specimens Grossing procedures Fixation protocols 10

6 TO Optimized antigen retrieval Optimized IHC Improved diagnostic accuracy 11 Handling of Biospecimen at Surgery TissueSAFE High vacuum formalinfree sealing unit installed in dirty room adjacent to surgery suite. Holding biospecimens in as fresh conditions Elimination of formalin in surgery suites. 12

7 TissueSAFE Operative sequence Sealing biospecimens under high vacuum in special plastic bags and immediately placing them in a controlled environment (2-4 C). 13 Activating the RFID smart card for time/temperature monitoring 14

8 Specimen Sealing Transfer bag with requisition form and time/date label 15 Placing specimen in the T-Cart 16

9 T-Carts for short/long transfer of specimens Mobile refrigerator set at 4 C with UPS 17 Mobile refrigerator for car The Milestone chain of custody Reading the smart card 18 Time-Temperature log

10 The quality of vacuum preserved tissue IHC Infiltrating ductal carcinoma of the breast. 64h at 4 C FISH Infiltrating ductal carcinoma of the breast. 64h at 4 C (A) Frozen immediately after removal (B) Preserved under vacuum at 4 C for 48h 19 Macro digital imaging for the grossing step 20

11 Remote control/interaction by directing operator in real time Video/Audio via Internet (TeamViewer) PA at grossing 21 Pathologist ProCUT XL/XXL Standardized cutting of fresh tissues 22

12 Same-day grossing of fresh breast at 5 mm Eliminating hours/day of gross hardening protocols 23 Checking thickness for reliable tissue processing Out of specified thickness Within specified thickness Laser-based measuring gives instant feedback for user 24

13 Full control of fixation in the histology lab Fresh Tissue Formalin Molecular Fixative Tissue Banking Now you can 25 To become a science, fixation must be under the control of the histology laboratory Standardization and documentation of: Thickness of blocks Specimen/Fixative volume ratio Type of fixative Time of fixation Temperature of fixation Stirring YES/NO Reagents management 26

14 Fully automated fixation system Dedicated unit for length of fixation up to 72 hours. Microprocessor control of all parameters. 27 Single step fixation plus rinsing Full access of fixation protocol documentation through interface and USB drive. 28

15 Fixation plus Holding Step Weekend/holidays After fixation time has elapsed, formalin is drained and PBS or an alternate holding solution is pumped in for reproducible fixation protocols. 29 Do you want a quick result, or the right result? With today s technology, accuracy and speed of diagnosis must not be an oxymoron 30

16 It is more than a slide it is a life to be continued 32

17 Milestone continues to push the boundaries of disruptive technology with our line of Rapid Microwave Tissue Processors and Imaging Products