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CpG Diagnostics: A powerful approach to early cancer detection

A powerful approach to early cancer detection

Ovarian cancer is difficult to diagnose and causes more deaths than any other cancer of the female reproductive system

Early detection of cancer by a technique called liquid biopsy holds the potential to dramatically improve outcomes for patients by helping physicians diagnose and begin treatment earlier in the progression of the disease — perhaps even before patients exhibit symptoms.

But while some liquid biopsy tests have been approved for use by the FDA, their application has been limited to certain kinds of advanced cancers.

Bodour Salhia, Ph.D., is founder and chief executive officer of CpG Diagnostics, where she is working to expand the liquid biopsy approach to ovarian cancer, a disease that is particularly difficult to diagnose.

“We’ve been focusing on high-grade, serious ovarian cancer,” said Salhia, who is also associate professor of translational genomics at the Keck School of Medicine at the University of Southern California. “It’s one of the most common and lethal gynecological malignancies. That’s where the biggest unmet need is.”

Ovarian cancer is lethal partially because it is difficult to diagnose.

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Bodour Salhia, Ph.D.

Founder & CEO
CpG Diagnostics

The least invasive and the most robust way to analyze circulating DNA from cancer, from tumors, is to analyze the DNA that is circulating in blood.

Bodour Salhia, Ph.D.

Founder & CEO
CpG Diagnostics

If a tumor is found in some other parts of the body, it can often be biopsied, and the cells from the tumor can be analyzed to determine if the mass is cancerous before a treatment is given. Pelvic masses, however, are typically not biopsied because doing so poses a risk of further spreading cancerous cells if the mass is indeed malignant.

The only way to definitively diagnose a patient with ovarian cancer today is to surgically remove the mass from a patient and analyze it. And while some tests do exist for ovarian cancer, they don’t perform very well on early-stage disease, Salhia said.

With OvaPrint, CpG Diagnostics’ lead program, Salhia is working to change that.

OvaPrint has two main purposes. The first is to determine the risk of a pelvic mass being cancerous before excising the growth. The ability to accurately determine this would help physicians plan the best surgical approach and treatment plan. The second is to use the test for early detection and risk assessment of high-grade serious ovarian cancer in asymptomatic women in both general and high-risk populations who are predisposed to the disease.

The Complexities of Liquid Biopsies

Liquid biopsy is a simple concept that is made possible by advanced science and engineering.

All tissue in the body, including tumors, shed genetic material like DNA and RNA into the bloodstream. These particles provide information about the tissue that they were released from. “The least invasive and the most robust way to analyze circulating DNA from cancer, from tumors, is to analyze the DNA that is circulating in blood,” known as cell-free DNA, Salhia said.

Developing a liquid biopsy is difficult in practice, however, because the test must distinguish the signal from the noise.

To isolate cell-free DNA, the liquid portion of blood — called plasma — is separated from the cells that makes up blood, including red blood cells, white blood cells and platelets.

“Cell-free DNA found in plasma can come from cancer cells, but it can also come from all kinds of normal cells in blood, including cells of the liver or white blood cells,” Salhia said. “There’s a lot of background information that we have to sift through to get to what is referred to as circulating tumor DNA. We then have to identify the discrete signal within that to serve as the biomarker.” 

The test Salhia and her team have developed analyzes biological material called cell-free DNA methylation, which is found in the plasma. 

DNA methylation is a process that regulates gene expression and provides extremely detailed information about the health of tissue in the body. Unlike a genetic mutation, which results in a change to the genetic sequence, methylation is known as an epigenetic mechanism, as it modifies the activity of a gene without an alteration to the gene itself.

DNA methylation provides a detailed and precise understanding of the characteristics of the cells that released the information, including the kind of tissue it came from and whether the tissue was cancerous. 

This analysis allows OvaPrint to determine a patient’s risk for ovarian cancer simply by analyzing the patient’s blood.

Cell-free DNA methylation is going to be one of the mainstays of liquid biopsy approaches to cancer detection, particularly in ovarian cancer.

Bodour Salhia, Ph.D.

Founder & CEO

Advancing to the Clinic

Salhia and her team are preparing a manuscript for publication that includes an analysis of more than 300 patient samples. This data will represent the core of the company’s Phase 1 study of OvaPrint. They are also working to launch the test by the end of the year so that it can act as a risk assessment in women with pelvic masses.

The company is in the Heal.LA BioScience & Healthcare Accelerator. This Larta program is focused on piloting and commercializing solutions to improve the health and wellness of underserved communities in Los Angeles, providing access to better care for all, and scaling these innovations to communities beyond LA. The company recently received financing to advance their mission, and Larta is working with CpG to develop a local pilot to benefit underserved women in the L.A area.

CpG Diagnostics is expanding beyond ovarian cancer, but Salhia is focusing on developing OvaPrint to help women with ovarian cancer in the near term.

She believes that the use of liquid biopsy holds substantial promise. “There’s a lot of additional room for new approaches to come to market” in the liquid biopsy sector, Salhia said. “Cell-free DNA methylation is going to be one of the mainstays of liquid biopsy approaches to cancer detection, particularly in ovarian cancer.”

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