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Biological Dynamics Aims to Boost Adoption of Raw Sample Biomarker Tech Through Microsoft Program

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NEW YORK – Biological Dynamics has developed and refined its electric field detection platform over the last year to capture, quantify, and analyze a variety of targets including extracellular DNA, RNA, proteins, and circulating vesicles directly from unprocessed samples.

The firm is now hoping that this work will pay off in new research partnerships fostered under the umbrella of a Microsoft commercial partnership program, to which it was accepted this January, said CEO Raj Krishnan.

The company's technology was initially spun out of academic work by University of California, San Diego researchers and uses alternating current to create a non-uniform electric field that can capture particles within particular size ranges while repelling those that are smaller or larger.

When a whole-blood or plasma sample is run through the chip and over a microelectrode array, target particles are attracted and bound after which they can either be analyzed on-chip or removed for further analyses.

"We've always seen the chip as an enabling [technology] because it's unique in its ability to be able to isolate all of these different biomarkers from unprocessed biological samples, but also to run these orthogonal markers in the same sample at the same time," Krishnan said.

The company's early publications were focused mainly on exosomes and oncology applications. In one study published last year in ACS Nano, for example, a team from the UCSD lab where the chip technology was initially developed piloted detection of pancreatic cancer biomarkers via isolated exosomes. That study followed a previous publication, also in ACS Nano, in which the same group demonstrated the ability of the chips to isolate glioblastoma exosomes from undiluted human plasma samples.

Later last year, some of the same researchers followed up with new data on glioblastoma in a study in Nature Scientific Reports, in which they isolated vesicles and subjected them to on-chip immunofluorescence staining to determine the concentration of glial fibrillary acidic protein and Tau.

In a small cohort, the group established threshold cutoffs by comparing extracellular vesicle GFAP and Tau levels in glioblastoma patients versus controls. When they applied these to a second, independent cohort of 15 glioblastoma patients and eight controls, they could discriminate cancers with high-enough performance that the authors said warranted further research. 

Although the scientific literature doesn’t yet reflect it, Krishnan said that Biological Dynamics has been continuing over the last year to develop the system far beyond just exosome detection and protein analysis — branching out to demonstrate a variety of both on- and off-chip biomarker capabilities in not only oncology, but also infectious disease and neurology.

"Internally, we've been focused on … three main areas," he said. "The majority of our work is in oncology. But using the same chips we also have data in infectious disease, specifically tuberculosis where we have been working with the Gates Foundation. And we have data in neuroscience where we've been working on Alzheimer's disease to try to identify [new] biomarkers."

In terms of platform capabilities, Krishnan said that the company has also been putting the system through its paces much more comprehensively than just experiments with exosome detection.

"We've now actually taken [cell-free] DNA, we've done quantitative PCR, sequencing — both next-gen as well as capillary." We have a MiSeq in house, so we've run whole-exome sequencing on oncology patients," he said.

In addition, "we can isolate and look at the protein markers, which we are doing in tuberculosis," he added. The platform essentially allows quantification of DNA or RNA molecules, of extracellular vesicles, analysis of specific biomarkers among those populations, and downstream sequencing in virtually any combination.

"It's very robust, and so that's what we have been working on: building the technology to that capability and also finding specific partners that we can work with."

According to Krishnan, Biological Dynamics' adoption into Microsoft's One Commercial Partner (OCP) program last month will now be key toward translating this platform development into new research and hopefully diagnostic development partnerships.

"They're now connecting us with various pharma and other potential partners that we can collaborate with and bring our products to market for both pharma services as well as other areas," he said.

Making the platform attractive to players in the field who are already doing DNA mutation detection in blood, or exosome detection, or RNA analysis — but for whom a raw-sample system could provide even better or easier detection —  is one arm of the company's strategy, Krishnan said. The other is applying the technology in-house and with academic collaborators to specific areas of unmet need, with the eventual goal of developing clinical tests.

The firm's work in infectious disease point-of-care testing, supported by the Gates Foundation is one arm of this, as is the early cancer detection work in pancreatic cancer that the UCSF team has already published on.

A third is reflected in the company's launch of its first defined assay product, a therapy response monitoring tool called OncoState IO, that involves quantification of cell-free DNA and is currently aimed at lung cancer.

Specifically, the assay isolates and counts long cfDNA molecules (greater than 300 base pairs), which Krishnan said represents a population that is non-apoptotic.

"We're starting out first offering it as a research tool for pharma services," Krishnan said. "Immuno-oncology is a pretty hot space right now and if you can help track [response] ... and find out what is working as fast as possible, that is a pretty valuable tool."

Because Biological Dynamics has its own CLIA lab, it could be possible at some point to implement clinical treatment monitoring using its electrokinetic platform in house "if we generate enough data," he added.

This response monitoring application has recently garnered attention from multiple players plying a variety of blood-based technologies, including DNA mutation detection methods and epigenetic signatures, so Biological Dynamics likely faces significant competition for adoption in both the drug development space and potentially the clinic.

"Right now, we're comparing [our approach] versus the gold standard of imaging and physician's assessment and using those clinical studies to show that we have some pretty good data," Krishnan said. The company hasn't yet published on this work though, he added.

Though he declined to quantify growth in the company's research usership over the last year, Krishnan said that Biological Dynamics is currently in the middle of a financing round intended to support the commercial rollout of expanded research services and future clinical test development.

In the meantime, the firm has continued to work with key academic partners including its collaborators at UCSC and Oregon Health and Sciences University. The firm is also expecting to soon be working with one other group at the John Wayne Cancer Institute, he added.

In the background "we've been setting up collaborations with various diagnostic tools as well as pharma companies," Krishnan said, of which the Microsoft announcement is "just one of the major ones" in this vein. "We've started generating revenue [from this] last year and obviously this year we hope there's going to be a pretty good year for us in that regard," he added.

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