Custom Solutions

IHC Assay Unknowns: The Hidden Risks to Your Clinical Trial

Undefined antibodies, uncharacterized assays, and blind development decisions can derail your study.

RISKS
UNKNOWNS
1. Target may require a new IHC assay.
  • Which monoclonal antibody to select?
  • How to define the IHC assay parameters?
  • Will you be able to transfer your CDx assay to trial sites with confidence?
2. No monoclonal antibody may yet be widely accepted for clinical use.
  • How to control for lot-to-lot variability?
  • How to sensitively measure loss of immunoreactivity over time (stability)?
3. Dynamic range and limit of detection (LOD) are unknown.
  • Will you develop your assay “blindly” or tailor it (quantitatively) to optimally distinguish responders from non-responders?
  • Without defining dynamic range and LOD, how will you efficiently and quantitatively compare different assay conditions?
4. Quantitative Quality tools for your IHC assay do not exist.
  • Without quantitative measures, how will you standardize multiple clinical trial sites?
  • How to reliably standardize multiple instruments at the same site?
  • How to accurately translate the clinical trial assay to routine patient testing?

Only Boston Cell Standards Can Help You Navigate Through These Risks

New IHC Clinical Trial Assays Often Require Custom Calibration and Statistical Process Control Tools

Calibration and SPC are proven assay development tools in laboratory medicine.

Benefits Of A BCS Custom Solution

Only A Boston Cells Standard Custom Solution Can Optimize Your Clinical Trial Assay

Reproducible reference materials traceable to NIST SRM 1934, a single permanent standard.

IHCalibrators® standardize instruments and scanners prior to the start of a clinical trial.

Instead of random patient samples, reproducible quality reference materials manufactured to ISO 13485 standard.

Quantitative standardization of assays generates more accurate data, improving overall effectiveness in clinical trials.

1st FDA clearance for quantitative controls in breast cancer given to BCS IHControls® panel

Antibody stability is verified using IHControls, coupled with Statistical Process Control.

Defining LOD provides the needed measure to adjust the assay for optimally distinguishing the responsive patient population.

Antibody lots are standardized by ensuring a consistent analytic sensitivity (LOD) using IHCalibrators.

LOD and dynamic range parameters facilitate accurate translation of the clinical trial assay to commercialization, ensuring that all those who can benefit are identified.

IHC assay analytic sensitivity is defined in laboratory medicine by LOD and dynamic range (linearity).

From Discovery to Diagnosis

Boston Cell Standards’ Unique IHC Quality Tools Deliver Critical Data

Calibration

for inter-laboratory standardization

Learn About Calibration

Statistical Process Control

for intra-laboratory standardization

Learn About SPC

Boston Cell Standards Quality Platform For IHC

The Many Ways BCS IHC Calibrators & Controls Empower Discovery

Because Every Discovery Begins With Data You Can Trust.

Integration of Calibrators, Quantitative Controls, Image Quantification Software, and Imaging

Consumable

IHCalibrators®

  • Enable calculation of LOD and assay dynamic range
  • Align labs to one another
  • Align instruments within a lab to one another
  • Align clinical trial sites with one another
  • Verify lot-to-lot reagent comparability
  • Optimize antibody dilution for maximal sensitivity and minimal background
  • Troubleshoot IHC assay problems
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Consumable

IHControls®

  • Quantitative Controls Enable SPC
    • Create Levey-Jennings graphs
    • Establish control ranges for acceptable performance
    • Compare control values to peers
    • SPC aligns a lab to itself over time
  • Verify heater consistency at each instrument slide position
  • Consistent biomarker concentrations from lot to lot
  • Simple and efficient management of IHC control inventory
  • Ready supply of hard to find IHC controls
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METRIC Software System

SPC Daily Report

  • Analyze IHControls® and provide daily Levey-Jennings graph (SPC)
  • Establish quantitative control ranges

IHC Calibration Report

  • Analyze IHCalibrators® and calculate LOD and assay dynamic range
  • Compare your LOD with peer labs or published data
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How Does A BCS Custom Solution Engagement Work?

 

IHC Calibrator Design: Peptide Or Protein?

BCS can help you determine whether to use a peptide or protein.

Examples Of BCS Custom Project Deliverables

Flow histograms of each calibrator level showing narrow peaks with coefficients of variation generally ranging from 18 – 24%.  This is normal with concentrations (x axis) that are in the 10,000 – 200,000 range.

This graph is the unconjugated blank control.

Comparison of analytic response curves for calibrators manufactured from peptide (orange circles) versus the recombinant protein (blue circles).  The two are nearly indistinguishable.

Robotic printing of IHCalibrator® slides.