Ernest Knesel – CEO, CellSolutions & Select Lab Group

Founder LabCorp, & Roche-TriPath Imaging (now BD)

Brad Knesel – President

Joel Dry –Vice President Product Development & Mktg.

Thanh Nguyen –Vice President Engineering

Meltem Algan Bertalan – European Product Manager

Augusto Ocana –Vice President International Sales

CellSolutions Management

CellSolutions Evolution

2001 – 2004 Development Manual Method & Preservatives

2006 – 2010 Automated Prep Instruments & Reagents

2012 CE Mark

2013 – 2017 European Product Launch

2018 BestCyte Product Launch – Ex-USA

CellSolutions 120 Launch

US FDA CLINICAL TRIAL

CellSolutions Evolution

Headquarters & Manufacturing

Headquarters

Greensboro, North Carolina, USA

Instrumentation Manufacturing

Greensboro, North Carolina, USA

Reagent Manufacturing

Westfield, Indiana, USA

Employees

12 in CellSolutions – 190 in Select lab Group

GYN Cytology Screening

Wright TC, Ferenczy A, Kurman RJ: Carcinoma and other tumors of the cervix. In Kurman R (ed): Blavstein’s Pathology of the Female Genital Tract. 5th ed. New York, Springer-Verlag, 2002.)

• George Papanicolaou – 1943 “Diagnosis of Uterine Cancer by the Vaginal Smear”.

Diagnoses of Cervical Cancer in U.S.

1975 - 31,942

2007 - 19,762

Deaths from Cervical Cancer in U.S.

1975 - 11,987

2007 - 7301

Cervical Cancer Trends in U.S.

CellSolutions Prices

• CS-30 Preparation Instrument- 29,000 E

• Flash System- Based on Distributor Cost

• BestCyte Server & Workstations- 15,000 E

• Reagents & Disposables- 2.10 E per Slide

• BestCyte Software License and Support- 1.00 E

• ______________________________________

• Price per Slide- varies with volume, yrs. of Use

5 Yr. Use- Variable Annual Volumes

Scanner not Included

• 10,000/yr- 3D-scanner+ .88 + 3.10 = 3.98 E

• 20,000/yr- 3D-scanner+ .44 + 3.10 = 3.54 E

• 50,000/yr- 3D-scanner+ .18 + 3.10 = 3.28 E

• 100,000/yr-3D-scanner+.09 + 3.10 = 3.19 E

_____________________________________

• Competition- 6 to 12 E – (depending on

volume with inferior preparation & imaging)

• Significant Labor Savings not Reflected

Resource Poor Countries

“Haiti Project”- (example)

• Cervical Cancer Death Rate- 50 X USA

• Goal to introduce CS Prep and BestCyte

________________________________________

• High Volume Testing- 300,000 sl/yr

• Eqpt- 2-CS120 & 2-Flash-250, Stainer/Cover

• Capital Cost Est. $400,000/5yrs/300,000=$.27

• Reagents & Disposables- $2.00/sl

• Haitian cytotech costs-$.23/sl

• Total Cost per Slide- BestPrep/BestCyte- $2.50

Conventional vs LBC

Conventional Cytology- Dirty Background

- Poor Cell Preservation

- No Uniform Quality

Liquid Based Cytology- Clean Background

- Optimal Cell Preservation

- Ancillary Molecular Testing

GluCyteTM Manual Method

Affordable Entry Level

30 Slides / Hour

Simple Process

Lower Cost

CellSolutions F50

50 Slides per Hour

Clean Background

Compact Design

Circular Cell Deposit (20mm)

Staining performed using traditional Papanicolaou Stain

procedure

Dual Filtration Method

CellSolutions 30

30 Slides Per Hour

Automated Sample Measurement for Consistent Cellularity

Automated Slide Tracking – Bar Code Printing

Standard Staining Rack Slide Output

Robotic- Walk-away

Automated Slide Preparation

120 Slides Per Hour

Available Summer 2018

CellSolutions 120

General Cytology Preservative

• Proprietary Preservative/Medium

– Ethanol Based

– Maintains Cell Morphology

– Molecular Friendly

– Non-Hazmat

– Applications:

• GYN

• Non-GYN

• Available Sizes

– 10mL vials (500 total)

– 1000mL Bottle

– 1000mL Bottles x 4

Liquid Based Cytology Competition

Hologic (Thinprep Method)

•Bloody and mucoid samples are problematic

•Increased Unsatisfactory Rate

•Special Expensive filter

•T-2000- Slow, High Labor, No Sample ID

•Collection device cannot be left in vial

•Toxic Preservative

Thinprep’s Blood Problem

• 76% squamous cancers and 60% of adeno cancers

“many” to “abundant” Precipitated Hemoglobin

• “….current results support previous findings that bloody

hypocellular ThinPrep slides can harbor significant

lesions.”

Preservative Comparison

Preservative Precipitation

One Hour One Week

CellSolutions Preservative does not Precipitate Blood.

BD (Surepath Method)

•Excessive front-end processing

•No positive sample identification

•Staining on processor has limited color range

•Expensive settling chambers & syringes

•Cell presentation appears “crowded” and three-

dimensional- hard to screen and scan

Conventional – No defined deposit area

CellSolutions – 21 x 14mm rectangle

Thinprep – 20mm circle

BD – 13mm circle- crowded and 3 Dimensional

Preparation Types

CellSolutions BD (Surepath) Hologic (Thinprep)

Method Manual or Automated Automated Automated

1 Step Centrifuge Concentration 2-Step Centrifuge Membrane Filter

Improved Preservative Fair Preservative Poor Preservative

Non-flammable, Not Toxic Non-flammable, Slightly Toxic Flammable & Toxic

No Special Consumables Expensive Settling Chambers & Expensive Filters

Syringes

Entire Brush & Sample to Vial Entire Brush & Sample to Vial 50% Sample Lost

Specimen Integrity Positive ID No Positive ID T-2000 - No ID

T-5000 - Positive ID

Preparation 21 X 14mm Rectangle 13mm Circle 20mm Circle

3D Effects Holes and Halos

Stain by Choice TriPath Stain Hologic Stain

Liquid-Based Comparison Table

CellSolutions Procedure

GYN Sample Collection

Rovers Cervex Brush

CellSolutions Cytology

Preservative

Specimen collection &

submit to lab CellSolutions Slide

processing Papanicolaou Staining

(manual or automated)

Coverslipping

(manual or automated)

CellSolutions Slide Product

Traditional screening

3DHistech Whole Slide ImagingCellSolutions BestCyte Digital Review

The CellSolultions Process

• Diagnostic Accuracy

• Optimum Quality

• Efficient

• Automation

• Scalable

• Low Cost

Find the Cat

BestCyte

The entire cell deposit is digitized and available for review.

BestCyte

Reduces cytology ‘Search’ function by condensing an entire slide presentation into a few galleries of digitized cells for diagnostic review.

Cell Sorter

• Fully automated slide scanner

capable of 24/7 operation

processing BestPrep slides.

• Networked storage for virtual

slides.

• Whole slide image analysis

using a new generation of

algorithms that are highly

accurate.

• Detection of abnormal cells of all types,

grouping those according to appearance and

specific characteristics - presented in high

resolution.

• Distributed networked system design allows

system to scale to match demand.

New generation Image Analysis System to assist Cytotechnologists

and Pathologists to significantly improve Cancer Screening Process

and improve economics, especially in high volume applications

Traditional Review

10 slides/hour

BestCyte Review

25 slides/hour

What is the difference in workload?

BestCyte

Web-based software allows for access to case review from multiple locations.

Imaging Relocation on Microscope

By Competition

vs

Digitized Image Review

By BestCyte

BestCyte – Digital Image Review

Slides are scanned into digital format, cells are

sorted into galleries based on cell morphology,

and cases are available for review and

diagnosis through the internet.

Cytology - Liberated by the World Wide Web &

BestCyte

Automated Screening Comparison Table

CellSolutions BD SurePath Hologic ThinPrep

System

BestCyte

First & Only Digital

Imaging

BD FocalPoint GS ThinPrep Imager

ScalabilityLow to High Volume

(3DHistech Scanners)Medium Medium

Throughput

(per slide)

~1 minute

(Flash III)~5-6 minutes ~3-5 minutes

Review

Station

High Res Digital Microscope Microscope

Format Targeted Cell Galleries

Diagnostic

11 Fields of View

Prescreening

22 Fields of View

Prescreening

Whole Slide

Review

Digital or Traditional

Microscope

Traditional Microscope Traditional Microscope

Interface to Lab

ComputerYes No No

BestPrep & BestCyte

BestPrep

Improved Preservatives

Best Quality and Economics

BestCyte

Fastest Scanner - 1 slide/min.

The Best Cell Classifier - AI

Best Image Quality

Ideal Human and AI Integration

CellSolutions - The future of Cytology