The Challenge

Immunohistochemistry (IHC) is a critical method of tissue testing for cancer . . . but IHC testing struggles with antiquated systems of measurement that other (blood) laboratory testing disciplines abandoned decades ago. Consequently, IHC testing suffers from a high error rate, leading to missed diagnoses and lost opportunities for better treatment.

 

Why the high error rate? These outdated IHC systems lack calibrated standardized units of measure, without which testing suffers from inaccuracy and imprecision.

 

Boston Cell Standards solved this technical challenge. Our unique IHC testing and calibration products empower scientists and pathologists to precisely quantify protein molecules in tumor cells, helping them develop new personalized treatments and perform consistently accurate IHC testing for cancer patients.

What do these objects have in common?

tape measure used as a synonym for immunohistochemistry calibration
scale used as a synonym for immunohistochemistry calibration
thermostat used as a synonym for immunohistochemistry calibration
wall clock used as a synonym for immunohistochemistry calibration

The answer is that they all have standardized units of measure: inches, pounds, degrees, and minutes.

 

They are also aligned to a single international standard of measurements for length, weight, temperature, or time, which are kept at organizations like the National Institute of Standards & Technology (NIST).

That’s why all tape measures, bathroom scales, thermostats, and clocks give the same measurement, within the accuracy of the device.

 

Standards and shared units of measure are important in modern society. We need them for building skyscrapers, launching satellites into space, telecommunications, transportation, and many other things, including creating tomorrow’s medicines.

Boston Cell Standards introduces the first immunohistochemistry standardized test measures.

Importance of Standardization In Blood Laboratory Testing.

Each data point is a separate published error rate study. Adapted from: S. Bogen. A root cause analysis into the high error rate in clinical immunohistochemistry. Appl. Immunohistochem. Mol. Morphol. 2019, 27(5):329-38

Before units of measure linked to international standards were developed decades ago, blood testing was inconsistent among laboratories; error rates were high.

 

After adopting units of measure linked to international  standards, test results among laboratories became aligned;  analytic error rates plummeted to less than 1 percent by 2000.

 

For example, serum cholesterol measurements are expressed in standardized units of milligrams per deciliter, linked to a  NIST standard that was developed decades ago.

. . . But Biopsy Testing (Immunohistochemistry) Lacks Standards.

Each data point is a separate published error rate study. Adapted from: S. Bogen. A root cause analysis into the high error rate in clinical immunohistochemistry. Appl. Immunohistochem. Mol. Morphol. 2019, 27(5):329-38

Immunohistochemistry (IHC) testing is the only field of laboratory testing that has no units of measure linked with a standard.  Consequently, IHC testing is imprecise, non-quantitative, and dependent on the laboratory performing the test. Until now, this has been a difficult technical problem to solve.

 

Therefore, the situation is as blood testing was decades ago; error rates up to 30 percent, affecting millions of patients. This limitation impedes the development of new medicines, complicates identification of best practice guidelines, and denies patients consistent standards of medical care.

 

Boston Cell Standards solved this problem.

Boston Cell Standards’ Solution

Boston Cell Standards developed the world’s first tools for standardized immunohistochemistry measurement, introducing standardized units of measure (molecules per cell) linked with an international standard (NIST SRM 1934).

 

We introduce precise, accurate measurement.

 

This breakthrough opens new opportunities for improved disease understanding, diagnosis, and treatment.

immunohistochemistry false positive reading