To quote Hannah Montana: Everyone makes mistakes. But when it comes to a cancer diagnosis, that’s something a provider can’t afford to make.
Boston Cell Standards (BCS), a biotechnology company Seshi Sompuram, Steven Bogen, and Kodela Vani co-founded in 2003, wants to modernize the way pathologists diagnose diseases such as breast cancer, colon cancer, and lung cancer.
When a doctor believes a patient may have cancer, they often perform a biopsy. In the lab, that tissue is stained. A pathologist needs to evaluate the color’s pigmentation on a scale from zero (light brown) to 3+ (dark brown). The darker the color, the more cancerous the tissue is. This process is called immunohistochemistry (IHC) testing, and relies on a judgment call rather than numeric standards.
BCS wants to change that with an international laboratory reference standard to take out the guesswork—which can result in a patient potentially receiving different diagnoses with the same tissue sample at different hospitals, if at all, Sompuram told Healthcare Brew.
“Each hospital, they think they have their own control, then they’re fine,” Sompuram said. “But our calibrators’ [ongoing] clinical study is telling people, ‘Don’t ignore the misdiagnosis being done. So far you didn’t have means to see that. But now, we have some tools available, and you should make use of them.’”
The Boston-based company provides a laboratory with artificial tumor cells to perform IHC tests on, alongside patient tumor tissue samples. Pathologists can then compare the staining of the tissue sample with the control and make a diagnosis.
To assist with this process, BCS created a scanner that can assess a stained tissue and numerically measure how pigmented it is in terms of “pixels,” which makes comparing similar shades of brown effortless, per Sompuram. He also said that while these scanners are not widely available at hospitals yet, the company can scan a lab’s glass slides and analyze the data for it.
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The company is working on “providing each hospital with this software scanning,” Sompuram said.
When pathologists don’t have a standard for IHC testing, it can create major issues.
Research from Denmark in 2016 found that 30% of IHC results rendered insufficient cancer diagnoses, which may be due to the high possibility of error in the testing process. Machine malfunctions and improper staining can skew an IHC test and result in unreliable (and potentially fatal) medical conclusions, per Sompuram.
To combat those issues, providers can run BCS’s control product through their IHC machines to ensure that their testing instruments, reagents, and antibodies are all able to provide accurate results, Sompuram added.
BCS doctors are performing ongoing clinical studies with over 100 labs across five countries for breast cancer, colon cancer, and lung cancer detection, per Sompuram. With the studies, the company strives to determine an international reference standard for IHC testing and figure out which diagnostic results correspond with which cancer treatments.
“We envision every lab—every hospital—using our calibrators,” Sompuram said. “Everybody's talking about the limit of detection, everybody is talking about standards, and then error rates going down to single digits.”