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Pancreatic Cancer Application Provides First Toehold for Biological Dynamics in Clinical Testing

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NEW YORK – With the receipt of breakthrough device designation from the US Food and Drug Administration last month, molecular diagnostics firm Biological Dynamics is preparing to validate and launch its first clinical product, a pancreatic cancer early detection test built on the firm's electrochemical multi-analyte detection technology.

Called Exo-PDAC, the test is designed to detect pancreatic ductal adenocarcinoma in high-risk adults, which include those with new-onset diabetes, a family history of pancreatic cancer, certain germline mutations, and other recognized risk factors. The company has collected data showing that a proteomic classifier gleaned from isolated exosomes can discriminate early-stage cancers from normal controls with high sensitivity and specificity.

Biological Dynamics has been exploring its Verita platform, a novel alternating current electrokinetic-based system, for several potential applications, including cancer, Alzheimer's disease, and infectious diseases, but pancreatic cancer has now emerged as its first commercial target.

"A lot of that baseline research work is still continuing, so that has not changed. But we have, I'd say, a renewed focus on things that we think can be more actionable in the clinic," Kevin Han, Biological Dynamics' chief financial officer, said in an interview this week.

"I'd say the best way to characterize us right now is that we're a platform technology company that is venturing into diagnostics using a multiomics instrument," he added, "and we're in this unique position because we have a platform technology [with which] we can isolate cell-free DNA and RNA, protein, and specifically exosomal proteins. So in some respects, we're just scratching the surface of what our technology can enable for the clinical community."

Many of the most prominent companies vying for a position in the emerging blood-based cancer detection market have chosen colorectal cancer as their first, or only target. Biological Dynamics is not alone however, in steering toward pancreatic cancer. Bluestar Genomics is developing a test for these tumors, also with FDA breakthrough designation but for a more specific population of patients with new-onset diabetes.

Freenome, which began with colorectal cancer also recently marked its intention to expand to pancreatic cancer, and Grail includes the tumor type as one of its many targets in the already-launched Galleri assay.

Unlike colorectal cancer, where clinical screening paradigms and reimbursement pathways already exist for colonoscopies and stool tests, pancreatic cancer doesn't have a framework built in for asymptomatic screening.

However, the disease's aggressiveness and mortality have made it just as prominent a target as CRC for early detection test development.

According to Biological Dynamics, only about 10 percent of pancreatic cancer patients survive five years. For those with metastatic disease, the two-year survival is less than 10 percent, and for the few with local disease, five-year survival is approximately 40 percent.

Biological Dynamics core technology differs significantly from many of its potential competitors, which employ genomic sequencing of cell-free nucleic acids to identify epigenetic signals. The Verita technology platform allows direct isolation of a variety of targets including cells and extracellular vesicles or exosomes.

Initially spun out of academic work by University of California, San Diego researchers, the system uses alternating current to create a nonuniform electric field that can capture particles within particular size ranges while repelling those that are smaller or larger. In the context of pancreatic cancer, the company has employed the platform to isolate exosomes, which it then analyzes with multiplex proteomic immunoassays.

Biological Dynamics hasn't published data on its work in pancreatic cancer since an initial proof of concept in 2018, but investigators presented some updated data this year at the annual meeting of the American Association for Cancer Research analyzing a small set of samples from early-stage bladder, ovarian and pancreatic cancer patients.

Researchers examined isolated exosomes for the expression of 54 cancer-related proteins using stepwise logistic regression and splitting the cohort into a training and test set. A resulting classifier trained to discriminate between cancers and healthy control samples demonstrated an overall area under the receiver operating curve of 0.95, with a sensitivity of 71.2 percent at 99 percent specificity.

The classifier's performance for the pancreatic cancers alone had a sensitivity of almost 96 at the same specificity.

According to Han, the success of this exosomal signal in distinguishing cancers was somewhat of a surprise. "In the past, we were looking at a lot of cell-free DNA markers, but we discovered that there was this whole other set of biomarkers attached to exosomes that no one had been able to really [explore] at scale because the workflow is very cumbersome for isolating exosomes," he said.

The strength of the firm's early data led it to prioritize cancer among its larger research pipeline, which includes neurologic and infectious disease diagnosis. And the plan now is to pursue a multi-cancer strategy but in a stepwise format, addressing individual tumor types separately. "We're definitely going to be targeting the colorectal cancer market because that is a market that has a pretty established reimbursement pathway. And then we'll be looking to accelerate the other cancers in the space," he said.

Han declined to provide detail about the company's ongoing studies to support FDA approval and clinical launch, but he said that company investigators have generated "a lot more data this year than last year" with even more to come.

"Part of that data that we generate next year will be discussed with the FDA. And now that we have that breakthrough device [designation] we have an open channel for communication with them, so we're very excited to work closely together to help us commercialize a product that can ultimately save lives and help patients," he said.

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