Liquid biopsy test rapidly monitors disease burden in patients with advanced breast cancer

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August 12, 2022

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Sukumar reports Cepheid research funding.

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Researchers at the Johns Hopkins Sidney Kimmel Cancer Center have developed an automated liquid biopsy test that can detect cancer DNA in the blood of patients with metastatic breast cancer within 5 hours.

Liquid Biopsy for Breast Cancer Methylation (LBx-BCM) works with a currently available molecular testing platform, GeneXpert (Cepheid), and can detect methylation in one or more of nine modified genes in breast cancer in 4.5 hours.

“Patients undergoing chemotherapy or other therapies for metastatic breast cancer really want to know as soon as possible how they are doing,” Dr. Saraswati Sukumar, professor of oncology and pathology at the Johns Hopkins University School of Medicine, in an interview with Healio. “In current clinical practice, they get X-ray imaging 8 to 12 weeks after starting chemotherapy to see if their tumors have shrunk or not.”

Sukumar spoke with Healio about the technology, plans for its future, and its value in saving advanced breast cancer patients a lengthy wait for imaging results.

Sanio: What is liquid biopsy for breast cancer methylation? and what inspires you a develop it?

Sukumar: We wanted to give patients a much faster snapshot of how their tumor is responding to chemotherapy. This test is capable of detecting tumor DNA spilling into the bloodstream and measuring whether tumor burden is increasing or decreasing with a single blood test. It is a test that can be read within a few hours of obtaining the blood sample.

What is the test detecting? Over the years, we’ve spent a lot of time trying to find those red flags that indicate tumor-specific methylated DNA is present in the blood. The methylated DNA in the blood is removed by dead tumor cells. Cell division and death occur continuously in the tumor. So when tumor cells respond to therapy, they begin to die off in large numbers. The smaller tumors that responded shed small amounts of methylated DNA, and the tumors that regressed completely shed no tumor DNA. If we see that the load of methylated DNA in the blood has decreased a lot from the start of treatment to within 3 to 4 weeks, we know that the patient is, in all probability, responding to therapy. On the contrary, if the levels of methylated DNA increase or remain stable, this tells us that the tumor does not respond to therapy.

Sanio: What is special about this test compared to with other tests that use methylation markers?

Sukumar: Many of the other methylated marker tests require a lot of laboratory expertise, or must be sent to a centralized facility to get the results. This cartridge-based test is so simple to perform that any lab technician can perform it. Imagine that a patient who lives in a remote area of ​​the country needs the test. It is not necessary to send the blood to a central location. The test can be done at any facility that has a decent lab equipped with a GeneXpert machine that can run the cartridges. Interestingly, these devices are already widely distributed in hospitals in low- and middle-income countries, where they are used to diagnose infectious diseases. The speed at which results are obtained is also invaluable to both physicians and patients when planning the next steps in treatment.

Sanio: How cash is?

Sukumar: This paper is about selecting genes that can better detect cancer in the blood using the automated cartridge system for the first time, to find out if a blood test can work on that cartridge. We have shown that it works in the cartridge and that we can get results in 5 hours. The test correctly predicted whether tumor burden increased or decreased 85 percent of the time. Most other methylated gene tests have not reached this level of accuracy.

healium: What’s next for this test?

Sukumar: We will soon announce the results of a prospective clinical study designed to validate our current findings. When a test is that simple and can be done with just a blood draw, it can be useful in remote areas with limited CT or PET imaging facilities. In these cases, the cartridge-based blood test we are developing to monitor response to therapy will be a boon. Much more testing is needed before the cartridge assay is used routinely in the clinic.

For more information:

yesDr Araswati Sukumar, can be contacted at Johns Hopkins University, Breast Cancer Program, 1650 Orleans St., Baltimore, MD 21231; email:

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