By MAKENA PRATT, correspondent
In the coming months, California State University Northridge associate professor of biology Cristian Ruiz Rueda, and researchers at Weill Cornell Medicine in New York City, hope to finalize groundbreaking efforts to develop a cancer detection method that can recognize cancer mutations in the earliest stages — with a mere blood test.
The testing method they are pursuing, known as a “cancer-detection assay,” utilizes biopsies that assess blood samples for DNA indicators that are released by tumors or by circulating cancer cells.
Their idea is to create a testing method in which “you will be able to go to the doctor and get your blood sampled the same way they use some of your blood to measure your blood sugar and cholesterol,” Ruiz Rueda said.
“You should be able to use some of the blood to test for markers associated with cancer,” he explained. “If you test positive, that would be an alert to say, ‘Okay, maybe you need to go have further tests.’”
Their goal is to improve patients’ health and survival percentage by detecting cancers before they spread throughout the body and become more challenging to fight.
Since 2020, Acuamark Diagnostics has collaborated with Ruiz Rueda and the team at Weill Cornell Medicine to turn the laboratory “assays” into low-cost commercial tests available to the public.
CEO and co-founder of Acuamark Diagnostics, Dr. Bernard Peperstraete, believes that time is not far away.
“Everything depends on resources,” he noted. But if things go well, “We could be ready for commercialization or pre-commercialization for our first product within 18 to 24 months,” said Peperstraete.
The “molecular genetic assay,” or test, that they are working on is incredibly sensitive and rapidly detects specific genetic DNA indicators of cancer — at the single-molecule level.
The method is vastly more effective than traditional methods of sampling tumors. The process would end the need to take samples from tumors in difficult-to-reach areas of the body, or tumors in such early stages that detection is difficult.
If doctors can find cancer sooner, they will have a better chance of preventing the disease from spreading. And that means saving lives and reducing patient suffering, treatment costs and hospitalizations. Ideally, Ruiz Rueda intends that his research will contribute to a widely available commercial test so people can get a biopsy from their doctor.
The test was originally designed to detect markers specific to colorectal cancer. But Ruiz Rueda and his collaborators hope the test can be escalated to detect the markers for all cancer types in people — a huge achievement in medicine and human health, if it comes to pass.
“[Developing this detection method] was very, very hard,” said Ruiz Rueda. “There was so much trial and error. We had several ideas of what could be good ways of finding that needle in the haystack and we had to try every single one until we found the right combination.”
Ruiz Rueda holds a bachelor of science degree in molecular biology and a master’s and PhD in microbiology from the University of Barcelona. He moved from Barcelona to Boston in 2006 to work on antibiotic resistance research at Tufts University School of Medicine.
Six years later Ruiz Rueda moved his work to Weill Cornell Medicine, Cornell University’s biomedical research unit and medical school in New York City. In 2013 he began working on the research contributing to this new cancer detection method and in 2015, he became an assistant professor at CSUN in the San Fernando Valley.
Ruiz Rueda continued his cancer detection research and in 2019 the cancer test was issued a patent, and in 2020 it was published in the journal Human Mutation.
But ot was not until the last few months that success began to show itself.
“We tried hundreds of permutations of different primers, conditions, and reagents,” he explained. “It’s sort of like winning the lottery — one number is gonna win, but you’re going to have to try lots of combinations.”
While Ruiz Rueda’s research to develop the test might be done, he faces more work before the cancer test shows up in doctors’ offices. Instead, the first product to emerge from this collaboration is a test called a CRC, which stands for colorectal cancer. “[The colorectal cancer test] is a pilot, to show the world we can do this,” said Peperstraet, “because it has received quite a lot of attention and visibility.”
Peperstraet said the company is taking a contrarian approach by developing their tests to be “ultra-low cost and convenient,” that at the same time will provide an “ultra-reliable screening as an aid for early cancer detection that is highly scalable and can be performed on commercially available equipment.”
He says Acuamark Diagnostics is different from other companies in this field, noting that they have developed their technology from the ground up — while others have retrofitted existing technology and tested whether it can be effectively used for early cancer detection.
“We actually decided that current technology would be inadequate for the need that the market has, and the amount of detection that’s needed in stage one and stage two detection cancers,” Peperstraete said. “So, we decided to build a new technology from the ground up — that’s a bit of a different beast.”
The team has continuously licensed their new technology as they test different versions of their tests, ensuring that they properly function and deliver accurate results. It has been a constant pattern of fine-tuning.
The final step to get the tests cleared for the market will be validation in which the assays produce the correct results in controlled case studies, and are then tested on volunteer patients. After that, they would pursue a regulatory path such as FDA-approved clinical trials and premarket approval from the FDA.
“It’s very close to our hearts,” said the doctor, because of the impact this test might have on thousands of people around the world.
Source: Orange County Register
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