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Biological Dynamics’ Clinical Study Gets IRB Approval

BIOTECH: Platform Uses Electricity to Isolate Exosomes

Electrical current has long been a method of interest for separating biological molecules from solution. Now, San Diego-based Biological Dynamics is preparing to prove that its trademarked exosome-isolation ExoVeritaTM  platform for early disease diagnostics is capable of the task and useful in detecting cancer.

Last month, Biological Dynamics announced it had received Institutional Review Board approval and will soon begin enrolling patients in its ExoLuminateTM  clinical study to validate its pancreatic ductal adenocarcinoma (PDAC) lab-developed test.

Harmeet Dhani, MD
Director of Medical Affairs
Biological Dynamics

“Using novel data, we are one of the first companies in this country to use exosome-isolation for early detection of pancreatic disease. We are accelerating its application by initiating the ExoLuminate registry trial, which will enroll for high-risk or clinically suspicious patients and their family members that share risk factors,” said  Harmeet Dhani, MD, director of medical affairs at Biological Dynamics.

The ExoVerit platform is based on science developed by Biological Dynamics founder Raj Krishnan at the Heller Lab at UCSD. Krishnan discovered a method of separating desired biological molecules of specified sizes using electricity without damaging them in the process – a feat which had long eluded others who sought to use electrical current for the task.

Paul Billings, MD
CEO
Biological Dynamics

“The principle of all our devices is alternating current tuned to whatever you want to get out of it – DNA, RNA, extracellular vesicles,” said Biological Dynamics CEO Paul Billings, MD, adding that the platform utilizes a “secret sauce” to coat specialized chips which allows the molecules to get close enough to the electrodes to be separated but not burn up in the process. “What we hope we’ve done is create the very best platform, the most efficient platform, the least damaging platform to efficiently isolate extracellular vesicles and exosomes.”

Early-Stage Detection

Although the platform instrument can be “tuned” to isolate different particles, Biological Dynamics is currently focused on exosomes – specifically exosomes that are markers for the presence of cancer.

“We discovered we could very easily – with not many protein markers – distinguish cancer from noncancer,” Billings said, adding that the exosomes are also present in “very early stages of tumors.”

What that means is that the Biological Dynamics platforms can detect cancer, even in Stage 1 when cancer is most treatable. The ExoLuminate study will focus on one of the deadliest cancers – pancreatic cancer – because of its poor survival rate caused by a lack of early detection.

The average five-year survival rate for patients diagnosed with pancreatic cancer is 11.5%, which is driven largely by current methods that detect PDAC at late stages. The five-year survival rate improves to 44% when patients are diagnosed at the localized, earlier stages when surgery can be effective. But this only constitutes about 12% of diagnosed pancreatic cancer patients.

Razelle Kurzrock, MD,
Chair, Precision Oncology
Medical College of Wisconsin  Cancer Center

“Although most pancreatic cancer is diagnosed at a late stage and is almost uniformly lethal, when pancreatic cancer is detected at Stage 1 – as can be achieved using exosome-isolation on the ExoVerita platform – survival rates can be as high as 80%. This promising research suggests the assay could become an integral diagnostic component for pancreatic cancer management,” said Razelle Kurzrock, MD, chair of precision oncology at  Medical College of Wisconsin  Cancer Center.

Powerful Platform

As a diagnostic tool, the ExoVerita platform is faster and cheaper than DNA sequencing and has a sensitivity of 99%, Billings said.

In addition, each generation of Biological Dynamics’ instruments gets faster. Early this year, the company will be launching an automated version of the instrument that is expected to lower the cost of tests by 80% and reduce the time it takes to complete a test. Currently, the process takes a day to day and a half of assay time to get results.

“And that’s not acceptable to me,” Billings said, adding that the next version of the platform will eliminate a step and be able to do all the protein analysis “right on the chip.”

“And that drops the cost dramatically,” he said, adding that the goal is to get tests down to $50-$100.

In addition to being useful as a diagnostic tool, the platform’s technology can also be helpful in developing therapeutics.

“One of the pillars of the company is to deliver exosomes and ensure the quality of exosomes for pharma companies to use – to help quality assure them, help target certain kinds of cell surface markers,” Billings said. “We want to be a companion diagnostic for them; we want to do response monitoring for them.”

Biological Dynamics

Founded: 2009
CEO: Paul R. Billings, MD
Headquarters: San Diego
Business: Multiomic platform for detecting diseases at the earliest stages
Employees: 70
Website: biologicaldynamics.com
Notable: Biological Dynamics’ ExoVerita platform was a finalist for an American Association of Clinical Chemistry’s Disruptive Technology Award in 2022.

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