Engineering New Accuracy For Cancer Diagnosis

Boston Cell Standards Introduces Calibration and Statistical Process Control to the IHC Community

The first laboratory testing standards for IHC that ensure accurate cancer diagnosis and treatment decisions.

IHC Challenges Our Solutions

One patient. One tissue sample. Different results.

Without cellular testing standards, IHC labs do not produce consistently accurate test results from the same patient biopsy.
This affects patients’ lives.

 

 

Boston Cell Standards Ensures That Pathologists Are Presented With Accurate Stains For Correct Diagnosis And Treatment Of Cancer Patients

IHC Challenges Our Solutions

One Common Challenge. One Comprehensive Solution.

IHC Leadership Has Recognized The Testing Accuracy Challenge and Proposed a Solution

Regulating IHC As An Assay Requires Adoption of Proven Quality Methods Used By All Other Clinical Labs For Testing Accuracy

“Pathologists require objective information about their laboratory’s IHC stains daily or weekly so that corrective action can be taken promptly. In clinical immunoassay testing, such information is delivered in a timely fashion via quantitative controls and calibrators.”

Read the Full Editorial

 “….NSH firmly believes that it is time to take the steps necessary to improve the quality of clinical IHC practice based on the principles set forth by Magnani and Taylor. “

Read the Full Letter

“We can certainly draw an analogy to clinical immunoassay concepts like analytic range, calibrated controls, and specified quality control ranges with regular assay monitoring and incorporate these into the IHC lab.”

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The Proof is in the Testing

Best In Class Scientific Review And Financial Support To Make IHC Testing Consistently Accurate

US. Food & Drug
Administration (FDA)
National Institute of Standards
and Technology (NIST)
National Cancer Institute (NCI) (National Institutes of Health)

National Cancer Institute (NIH) Funding Awards To Boston Cell Standards

Fiscal Year Funding Amount
2002 $356,510
2004 $660,346
2005 $428,422
2006 $545,666
2007 $678,478
2008 $373,948
2011 $301,893
2014 $219,202
2015 $679,166
2016 $477,976
2017 $749,890
2018 $751,890
2021 $1,101,356
2024 $1,995,119
Total $9,319,862.00
Source: NIH Research Portfolio Online Reporting Tools (RePort).
https://report.nih.gov

National Cancer Institute (part of NIH) has provided more than $9 million in funding grants to BCS over more than 20 years, including funding for BCS’ launching of the Consortium for Analytic Standardization in Immunohistochemistry (CASI)
International Organization for Standardization (ISO)

Our progress is well-documented

Research Studies Validate The Effectiveness Of Boston Cell Standards For Improving IHC Testing Accuracy

Nov/Dec 2024

Study Highlights Superior Analytic Sensitivity of New HER2 Immunohistochemistry (IHC) Breast Cancer Assay Using Boston Cell Standards’ (BCS) IHCalibrators®

Jan 2024

Canadian Immunohistochemistry (IHC) Harmonization Study Highlights The Value Of Boston Cell Standards’ (BCS) IHCalibrators® For Improving IHC Testing Accuracy And Standardization Across Labs

Dec 2023

Memorial Sloan Kettering Cancer Center Study Demonstrates 100% Accuracy in HER2 Breast Cancer Testing Using Boston Cell Standards’ (BCS) IHCalibrators® with Automated Image Analysis

Dec 2024

Dutch Immunohistochemistry (IHC) Study Highlights Variability In Breast Cancer Testing and Role of Boston Cell Standards’ (BCS) IHCalibrators® In Enhancing Testing Accuracy Across Labs

Benefting those that depend on consistency

BCS Supports Two Markets That Require Accurate
IHC Testing

 

IHC Clinical Testing Labs

IHCalibrators® are used for new assay validation, lot-to-lot  and instrument-to-instrument alignment, assay troubleshooting, and proficiency testing. IHControls® are
used to track intra-lab day-to-day variability using Levey-Jennings graphs.

See How
Pharma/Life Sciences

BCS products are used in drug development to lock in and track IHC assay consistency between pre-clinical and clinical trial phases, among clinical trial sites, at individual trial sites over time, and translation from clinical trial to commercialization. All of these are important to ensure correct patient treatment stratification.

See How