Characterized FFPE

Information

Why do people work with us on FFPE projects?

We have an experienced histopathology team

• Dr. Walter Grundy, board certified head pathologist in Anatomic Pathology and Clinical Pathology and Cytopathology

• Rod Beck, Histopathology Lab Manager, 20 years experience, including leading IHC assay development for Applied Genomics and Clarient

• Christina Derriso, Conversant Bio's Senior Histology Technician, prepares custom products including TMAs, slides, and curls; Certifications – HT(ASCP) QIHC

• Dedicated FFPE project management and data specialist team to ensure projects are processed in a timely manner

And a wide array of FFPE

• Thousands of QC’d blocks available including hard to find blocks

• Quality control process overseen by 2 U.S. licensed pathologists

• Blocks generally larger because they have not been cut and re-embedded

• Clinical sites with new inventory that has not been picked over

Including characterized blocks

PIK3CA

10-30% of CRC patients have this mutation

• Mutation confirmed using PCR testing method by proprietary Lab Developed Test

• Tested at U.S. based clinical lab by fellowship trained molecular pathologist

• Melanoma BRAF expected late October 2015

EGFR

10-35% of Lung Cancer patients have this mutation

Colorectal CancerLung Cancer

KRAS

36-40% of CRC patients have this mutation

KRAS

15-25% of Lung Cancer patients have this mutation

Breast Cancer

PIK3CA

8-26% of Breast Cancer patients have this mutation

BRAF

8-15% of CRC patients have this mutation

NRAS

1-6% of CRC patients have this mutation

Tested by a CLIA certified partner

• 40+ pathologists• 50 years in operation• Fellowship trained in

molecular diagnostics

January April July

Evaluated 7 bids from clinical, diagnostics, and pathology labs through an extensive RFP process.

US clinical pathology lab selected.

Sections tested according to best practice for mutation and data returned to Conversant Bio for annotation.

• 40+ pathologists• 50 years in operation• Fellowship trained in

molecular diagnostics

January JulyApril

*Note: Last year 1 site yielded 2,000 cases and a total of 25,000+ blocks

Quality control strategy Step 1

Boxes of tissue blocks received with base clinical data and pathology report.

Quality control strategy Step 2

Breadth

Depth

Adrenal GlandAMLB Cell LymphomaBladderBrainBreastCarcinoid

BreastColorectal

CLLCRCEsophagealFollicular LymphomaGallbladderGastricGIST

Surgical cases QC’d by U.S. board certified pathologist. We begin with client requests, then follow the breadth and depth strategy.

GBMHead & NeckIBD (Crohn’s/UC)Kidney/UreterLiver (HCC)MelanomaMultiple Myeloma

NHLOvarianPancreaticProstateSarcomaThyroidTonsils/ Adnoids

Lung Prostate

What is the tumor size?

What is the tumor percentage?

How many 4um sections are available in from the tissue present?

Proper Fixation is Critical

If not fixed properly, it will result in:

*An inability to make an adequate slide

*Difficulty to determine how large the tumor is which affects prognosis

*Degradation of proteins, making it impossible to detect certain markers and proving unreliable for IHC, FISH, PCR, and NGS

Does the block match the pathology report?

Does the block look to be in good condition?

Is there necrosis present?

Quality control strategy Step 3

We provide quantitative QC block data and answer the following questions:

Is the tissue well fixed?

QC data provided with each block

• Diagnosis

• Resection Date

• Gender

Patient Information Block Information

• Tumor Type

• Tumor %

• Biopsy vs. Resection

• Staging (Clinical and TNM)

• Pathology Report

• Estimated 4 um sections

• Tissue and Tumor Size (mm)

Data available – path report

Data available – cancer registry

• When available Commission on Cancer outcome data can be provided with blocks.

Choosing your blocks

Which block has the highest tumor load? Tumor Load 100% Tumor Load 75% Tumor Load 40%

Which block has the most utility?

• OK for <10 4um sections

• OK for 1 10um curl

• OK for whole block sale

• 1 x 13mm tumor

• OK for >100 4um sections

• OK for >20 10um curl

• OK for whole block sale

• OK for TMAs (thick)

• 16 X 12mm tumor

• OK for <50 4um sections

• OK for whole block sale

• Not ideal for assays (shallow)

• 1o X 5mm tumor

Customers rely on us to obtain

hard to find samples

• International companion diagnostics lab needed access to NRAS samples.

• The NRAS mutation is seen in less than 6% of Colorectal Cancer patients.

• We provided 7 blocks for their initial studies

Customers rely on us to obtain

samples for multiple projects

• The same international companion diagnostics lab returned with a second project and needed EGFR and KRAS blocks.

• They selected 25 EGFR and 25 KRAS blocks from our QC’d inventory.

• From time of request to shipment of these blocks took less than week.

Customers rely on us to save them time

by receiving research ready products

• U.S. based diagnostics lab needed access to characterized BRAF FFPE samples.

• Additionally, they needed a partner to provide curls from each block.

• We delivered 20 sets of curls and blocks within 24 hours of receipt of a purchase order.

Phone (866) 838-2798

Email sales@conversantbio.com

Web www.conversantbio.com

Visit 601 Genome Way, Huntsville, AL 35806

Contact us for any project needs

Access available inventory and data reports at:www.conversantbio.com/ffpe-inventory

Customers rely on us to obtain

quality samples

A research group at an internationally renowned biotechnology firm requires a large number of FFPE blocks to complete their study. Consequently, they reached out to Conversant Bio to source blocks. The group found the success rate of their research to be 40% higher when they used our blocks, and they are now reordering FFPE blocks from us on a consistent basis. This team has found that our quality saves them time and money.

Year End Budget Spend

• Completed multiple projects with customer over a 5 year period• Needed to make a large spend to exhaust their yearly budget and

prepare samples for the upcoming year.

Project Details

Diseases = 100 Colorectal Cancer (57 Stage III and 43 Stage IV)48 Ovarian Cancer (32 Stage III and 7 Stage IV)51 Lung Cancer (30 Stage III and 21 Stage IV)

Sample Type = TissueFinished Good = 199 FFPE Blocks

Inclusion Criteria = One Block Per Case; All Cases Stage III or IV10 - 15 x 4um Sections Needed Per Block>15% Tumor LoadOrder of Preference via Path Report:

(1) Tumor From Metastatic Site (2) Lymph Node (3) Primary Resection

Exclusion Criteria = None Additional Data = NoneShipping = FedEx Priority Overnight Protocol = Conversant Bio SOP

Customers rely on us to complete

their year end spends

Customers rely on us to obtain

a wide variety of samples

• Contract Research Organization needed a variety of specimens• Conversant Bio sourced all the samples needed the project • 5 days from the date of the initial request to the time the order shipped

Diseases = 25 Squamous Lung Cancer20 Normal-Adjacent Tissue from Squamous Lung Cancer5 Normal Donors

Sample Type = Tissue; Peripheral Blood Finished Good = 25 Disease FFPE Blocks

20 Normal-Adjacent Tissue FFPE Blocks Fresh Whole Blood from 5 Normal Donors

Inclusion Criteria = One Block Per Case; 15 x 4 um Sections Needed Per Block; Tumor Positive for Disease;Male Normal Blood Donors

Exclusion Criteria = None Additional Data = NoneShipping = FedEx Priority Overnight; Ambient Protocol = Conversant Bio SOPTime to Completion = 1 Week

Project Details

Phone (866) 838-2798

Email sales@conversantbio.com

Web www.conversantbio.com

Visit 601 Genome Way, Huntsville, AL 35806

Contact us for any project needs

Access available inventory and data reports at:www.conversantbio.com/ffpe-inventory

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