Detailed Guidelines for Specimen Selection

We have outlined physicians specimen guidelines to properly prepare and ship specimens for testing.

We prefer blocks but also accept unstained slides.

SELECTING THE MOST REPRESENTATIVE TISSUE BLOCK FOR SLIDE PREPARATION

A. The standard neutral buffered formalin is the preferred fixative. If fixed in alternate solution, please indicate the fixative. Maximum duration of fixing time acceptable is 72 hours. Note: If non-standard fixative used, the test performance may be delayed or specimen retuned without testing.

B. CLIA regulations require that the slides for the test be prepared from the same block used for diagnosis.

C. Choose the block with the most number of proliferative hyperplastic ducts for preparing the slides among the available blocks.

D. If the diagnosis is atypia, make sure the block chosen for cutting slides has atypical ducts.

E. If the diagnosis includes histologically multiple types of hyperplastic ducts, the preferred block for cutting slides will be the one which contains the most histological types.

F. Blocks which have fibroadenomas with or without hyperplasia are not acceptable. However, if blocks are available which have hyperplastic ducts outside of fibroadenoma, those samples are acceptable.

G. One H & E slide from the block selected for cutting the slides is required. The histology of the H & E slide should match the histology described in the pathology report. If there is no match, the block will be sent back without performing the BBDRisk Dx™ Test.

Guidelines for Slide Preparation and Shipping

SPECIMEN SLIDE PREPARATION INSTRUCTIONS

Unstained Slides

1. Follow standard guidelines for preparing the slides

2. To reduce cross-contamination, use a new blade between specimens and clean the water bath after each specimen

3. Prepare six 5 μm serial unstained slides. A single 5 μm section should be placed on a standard charged slide.

4. Hand number the serially sectioned unstained slides (1-6) to indicate the order in which they were cut.

5. Once the slides are ready, insert them along with an H&E stained slide cut from the same block into slide carriers and place the slide carriers provided by Silbiotech, Inc. in the shipping envelope.

6. If residual atypia is limited in the block from which the diagnosis was made, slides can be cut from more than one block. If slides are cut from different blocks, H&E slides from each block are required.

SHIPPING INSTRUCTIONS

MATERIALS:
1. BBDRisk Dx™ Requisition Form

2. Copy of Pathology Report

3. BBDRisk Dx™ specimen kit containing the patient specimen

4. If the block is shipped, place a cool pack in summer to prevent melting.

5. FedEx® US Airbill pre-printed with Silbiotech, Inc. shipping information

6. FedEx®Clinical Pak, Large — a plastic “over wrap” used to ship the specimen to Silbiotech, Inc.

7. FedEx®adhesive airbill pouch for the FedEx® Airbill

SHIPPING THE REQUISITION FORM AND SUPPORTING MATERIALS:

1. Complete one BBDRisk Dx™ specimen kit and Requisition Form for each patient sample

2. Before shipping, make a copy of the BBDRisk Dx™ Requisition Form and retain it for your records.

3. Place the Requisition Form, specimen kit, a copy of the pathology report, and relevant patient insurance materials in the shipping envelope and mail.

4. For international orders, a customs declaration form and payment in the form of a money order in US dollars are needed.