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San Francisco, CA, United States

Schwartz M.,Fluxion Biosciences Inc.
American Laboratory | Year: 2015

Liquid biopsy offers the potential to understand and treat cancer in an effective manner. The primary advantage of liquid biopsy is its ability to access tumor content at all critical inflection points, such as at the start of a new therapy or temporal monitoring of an existing course of treatment. This is facilitated by a conventional blood draw that makes the sample collection process more tolerable for the patient. Source

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 203.58K | Year: 2009

DESCRIPTION (provided by applicant): The detection and analysis of rare cells is a pervasive challenge in cellular biology and clinical diagnostics. Fluxion Biosciences proposes the development of a high throughput instrument and microfluidic consumable to conduct rare cell isolations for research and clinical applications. Targeted cell isolations are important to numerous fields such as cancer research, stem cell biology, prenatal care and immunological disorders. Quantifying the number of circulating tumor cells in the bloodstream is one such application that can lead to early cancer detection and can help monitor disease progression during treatment. These cells occur as low as one in ten million cells. Other compelling applications requiring rare cell detection include screening fetal cells during pregnancy for genetic aberrations and performing CD4 counts for immunocompromised patients with HIV. Modern laboratory tools such as centrifuges, cell sorters and cytometers are poorly equipped to detect and analyze cells appearing in such low frequencies. Although many kits are commercially available for conducting routine cell separations, most exhibit very poor recovery and purity yields when it comes to low prevalence target cells. This proposal aims to develop a microfluidic chip for rare cell isolations using the Company's well-plate microfluidic technology. The proposed research entails use of laminar flow streams to create efficient and accurate cell separations with high recovery and purity of targeted cells. The resultant product will deliver an automated, high throughput platform for conducting rare cell isolations on the research and clinical settings. Fluxion's approach represents a significant breakthrough over existing technologies which are mainly confined to low throughput, low efficiency cell isolations performed in filtration columns or well plates. The proposed system also enables multiple downstream analysis options with minimal cell handling and trauma. Cells will be available directly in the microfluidic devices for microscopic observation, high content screening and automated detection using a fluorescence plate reader. Cells will be easily removable from the devices for further analysis such as RT-PCR. Clinicians and researchers will be able to leverage this versatility of analysis and high throughput, high efficiency cell sorting to greatly enhance their productivity in life saving discoveries, diagnoses and treatments. PUBLIC HEALTH RELEVANCE: An unfortunate aspect of cellular biology is that the cells which hold the most promise for clinical diagnosis, disease progression and biological understanding often occur in the lowest frequencies. Circulating tumor cells can aid in the early detection and treatment of cancer yet appear as only one in ten million cells. A similar low prevalence is true for fetal cells found in the maternal bloodstream which could offer noninvasive ways to screen for genetic disorders earlier in pregnancy. Modern laboratory tools such as centrifuges, cell sorters and cytometers are simply not equipped to detect and analyze cells appearing in such low frequencies. This proposal aims to develop a high throughput system to isolate rare cells from biological samples and provide a range of analysis options to accommodate the desired endpoints of both clinical and research applications.

Apparatus and methods are provided for analysis of individual particles in a microfluidic device. The methods involve the immobilization of an array of particles in suspension and the application of experimental compounds. Such methods can also include electrophysiology studies including patch clamp recording, electroporation, or both in the same microfluidic device. The apparatus provided includes a microfluidic device coupled to a multi-well structure and an interface for controlling the flow of media within the microchannel device.

Fluxion Biosciences Inc. | Date: 2011-07-14

Methods, microfluidic devices, and instruments for magnetic separation of particles from a fluid are described. Examples include microfluidic devices having a removable portion. Examples include microfluidic devices having one or more regions of reduced fluid velocity. Examples further including instruments having pneumatic interfaces. Examples further includes instruments having controllable magnets, imaging components, or combinations thereof.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--In advance of the 2015 American Society of Clinical Oncology Annual meeting, Fluxion Biosciences, Inc. and Swift Biosciences, Inc. announced a new workflow for oncology clinical research designed to detect somatic mutations from a routine blood draw. The jointly-developed workflow utilizes Fluxion’s IsoFlux™ System for circulating tumor cell (CTC) enrichment and Swift’s Accel-Amplicon™ technology for high sensitivity variant detection using low starting inputs. Liquid biopsies represent a major breakthrough in the ability to detect molecular changes in tumor progression without the need for a tissue biopsy. They offer the potential to characterize cancer in real time using only a routine blood draw, enabling targeted therapies to be used simultaneously monitoring for response and resistance. Until recently, this approach has been limited by the available amount of tumor DNA that can be recovered from peripheral blood samples. The IsoFlux System enriches rare tumor cells circulating in the blood using a combination of epithelial and mesenchymal markers, and delivers them at high purity for molecular analysis. Swift’s Accel-Amplicon 56G Oncology Panel provides sensitive mutation detection across 56 cancer-related genes using very low starting DNA inputs from the IsoFlux System, making this combination of technologies especially appropriate for liquid biopsy samples. “We’re pleased to be working with Swift on this application for translational oncology research,” said Michael Schwartz, VP Marketing at Fluxion. “We expect the combination of blood-based tumor DNA enrichment and broad tumor gene coverage to be put to good use by the types of institutions that are pursuing diagnostic strategies based on liquid biopsies.” “This workflow is a wonderful example of how innovators can collaborate to produce advanced tools for oncology research,” noted David Olson, CEO at Swift Biosciences. “Fluxion's CTC enrichment is a great pairing with our 56G Oncology Panel, and we are pleased that our respective technologies can be used together to shine new light on cancer biology.” The combined workflow begins with a standard blood draw and proceeds to CTC enrichment using epithelial and mesenchymal antibodies. The captured CTCs undergo DNA extraction and purification without the need for whole genome amplification. The genomic DNA then goes through target enrichment using the 56G Oncology Panel and library preparation for Illumina sequencers. The resulting data utilizes a custom bioinformatics pipeline designed to identify low frequency variants from liquid biopsy samples. The complete workflow is described in an application note and the products involved are available from Fluxion and Swift. For more information, please visit: www.fluxionbio.com and www.swiftbiosci.com. Fluxion Biosciences brings the power of cellular analysis to the benchtop with advanced tools to automate complex assays. The company’s IsoFlux System enables translational oncology research using a non-invasive liquid biopsy. This platform utilizes high-sensitivity circulating tumor cell (CTC) collection to facilitate broad-based genomic analysis using tools such as Next Generation Sequencing (NGS). This approach provides a more comprehensive look at the disease status, as compared to alternative approaches that only look at limited panels of known mutations. Fluxion’s other products, the BioFlux System and IonFlux System, have helped hundreds of research institutions and pharmaceutical companies around the world advance their cellular research and drug discovery. Swift Biosciences is developing innovative and enabling technologies for genomics research. The company’s Accel-NGS product portfolio brings unique capabilities to improve the efficiency and quality of (NGS) sample preparation across multiple applications. The Accel-NGS library preparation kits offer superior sequence coverage metrics, even from challenging samples, and can generate PCR-free libraries for whole genome sequencing from as little as 10ng of genomic input. The Accel-Amplicon products encompass multiple panels that include 56G, a stand-alone TP53 panel, and custom panels across multiple genomes. Swift Biosciences also offers kits for bisulfite converted DNA for methylation sequencing and a product for single-stranded DNA, ideal for viral and phage metagenomes.

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