Complete Solutions for Liquid-based cytology

First intro in 1995 by Cytyc utilizing “filter” technology, ThinPrep®.

2nd player ; TriPath Imaging utilized “centrifugal” chemistry , SurePath™ in 1997.

3rd entry was “manual LBC” , CellSolutions, Liqui-PREP, NuView, etc. in 2004.

Each technology approach has its strengths and weaknesses which customers chose based upon their needs.

Patient mix (symptomatic/healthy) Sample volume & sample mix Lab skill sets & staffing Costs per test Cost in Use Screening skill level

Sales

Pap

Filtration

Centrifugation

Cytospin

■ WW adoption of LBC is growing

■ More LBC platforms are appearing

■ LBC systems compatibility to

molecular methodologies is a growing

issue ,i.e. DNA carryover , enzyme

compatibility, platform format

■ Costs of LBC are more competitive

■ Labs have different issues

■ Countries have different economics

■ Cytology is growing way beyond

cervical cytology.

TP200024 samples/hr3 min hands on per sampleTP300080 samples/8 hr shiftLess hands on time

TP500020 samples batch“walk-away” automation

■ All utilize same single filter technology■ Requires (55%)methanol based Preservative to “swell” cells■ 20+ year old unchanged technology■ Changes morphology/requires retraining■ Historic Gold standard for LBC

■ All platforms have carry/over DNA issues-

TP2000

Cytec was acquired by Hologic

■ requires 2 off-line centrifugations

■ assembly of plastic settling chambers

■ process 48 samples/hr

■ can stain slides

■ causes DNA carry-over; pre sampling

required

■ handles messy samples better

■ expensive platform (Tecan pipettor)

TriPath Imaging was acquired by BD

ALL cells collected are

poured onto the

Cleaning Solution

Features:

► Whole specimen is processed.

►Utilizes separation chemistry to remove

mucus.

►Lytic Preservative lyses red blood cells.

►Clinically relevant cells travel to bottom.

►Bacteria, yeast, fungi, protozoan are

preserved and captured in cell pellet

► Some issues with molecular methods and

its chemistry.

Step 1

Step 2: 800g force-10 minutes

BD FocalPoint™ Slide Profiler

ThinPrep Imaging System

■ Adoption driven by insurance reimbursements (USA)

■ Developed markets high labor costs foster usage

■ “Performance” of the technology questionable ■ Read ‘defined field’ – what about outside the field?

Complete Solutions for Liquid-based cytology

We want to help you decide what is best for YOUR laboratory!

Offers full range of LBC options Manual format for small labs-

CellSolutions Kits

“Filter” approach utilizing 2nd generation filter technology-

CellSoutions F50CellSolutions F100

“Centrifugation” platform with fewer parts-CS-30

Offers full range of reading options BestCyte Software for sorting cells based

upon cell type. Digitalizes every cell on the slide, not

selected fields. Various reader through put: 1 slide, 12 slide or

250 slides per batch. Internet based for telepathology or remote

access.

CellSolutions Manual format

CellSolutions F50Filtration technology

Cell Solution® 30Centrifugation technology

For smaller labs (<50 day) with no barrier to adoption

Most affordable approach to LBC adoption As volumes grow; any platform can be

brought in. Proven publications and adoption by

hundreds of labs over the past 10 years. Compatible with molecular methods and no

platform or format issues. Quality varies by technologist.

■ Eliminates centrifugation

■ Various processes for various sample types

■ Removes inflammatory cells

■ Provides consistent slide “monolayer” appearance.

■ Slides compatible with BestCyte® Cell Sorter

F50 – 50 samples/hr. F100- 100 samples/hr.

● Adjustable processor parameters for various sample types.● Removes Inflammatory cells & cellular debris.● No DNA carryover since instrument doesn’t sample primary vial.● Positive ID can be added simply.

TP2000 CellSolutions F series

Preservative 55% methanol ethanol

Labor Release 3 min/sample24 samples/hr

F50: 1 sample/min; 50 samples/hrF100: 2 samples/min; 100 samples/hr

Filter Mono format- methanolused to swell cells

Dual filters with “adjustable” instrument parameters

Instrument Single filter formatOnce cycle formatDNA carryover

Dual filter format5 cycle formats70% sample retainedNo DNA carryover

Slide quality MonolayerMorphology changed

Monolayer

Pre-treatment Acetic Acid Density Cleaning Solution to lift mucusLytic to lyse excess RBC

Load up- Press GO-walk away! 30 samples/ hour Level sensing probe can sample any

size sample, allowing for specimen variation

Positive sample/ID. User selectable cellularity. Primary sample not exposed to any

reagents. No DNA carryover. Select multiple slides (1-3) from a

sample. Installed base worldwide since 2010.

All cells are digitized from the entire slide. Cells are sorted into field of similar

appearance to allow for simpler comparison. Suspect cells are ‘highlighted’ for review. Various Reader options to address your

laboratory volume (batch size, 1:12:150:250) Remote tele-pathology and up to six stations

per system.

We can help you choose WHICH platform and technology can address YOUR lab and YOUR patients.

Scalability Chemistry and platforms are molecular

friendly and considerate of carry-over issues. Lets talk!