Veridex, Lcc

Immunivest Corporation

Aviana Molecular Technologies, LLC

Janssen Diagnostics, LLC

Herman Rutner

Paul A Liberti

Galla Chandra Rao

Leon W M M Terstappen

Shawn Mark O'Hara

Steven Gross

Madeline I Repollet

Christopher Larson

Leon Terstappen

Jerry Prohaska

Michael Kagan

Lisa Laury-Kleintop

Teresa Bendele

Dave Howard

Douglas Keene

Dave Lapeus

Jared Mayes

Douglas Paynter

Thomas Harbart

Shawn Mark O'hara

Melissa Hermann

Madeline Repollet

Biosensor components (chips) are described based on direct biocoating processes that result in the tenacious and stable, noncovalent (believed to be chemisorptive) binding of anchor substances such as avidin(s) other proteins having specific binding partners or oligo- or poly-nucleotides onto any piezo-electrically active crystal surface. The resulting platform technology can be developed for a variety of biosensors with specific applications in biological assays. The table mono layers of the anchor substances forms reactive layers, ready to bind a capture reagent such as a biot-inylated antibody for capture and detection of analytes in biologic fluid samples. Although the processes described herein can be performed on any type of piezoelectric material in any number of configurations, some embodiments are directed to a biosensor with the foregoing biocoating onto a particular acoustic plate mode biosensor and where the interdigitated transducers (IDTs) are present on the opposite side of the crystal's biocoated film.

Biocoated piezoelectric biosensor platform for point-of-care diagnostic use

The present invention provides a protocol and apparatus for enriching circulating tumor cells and other rare cells from blood, including debris and other components, from samples with high precision and at high throughput rates. This invention discloses an improved processing system from previously described semi-automated sample processing. The system further reduces operator intervention and hands-on time from prior systems. While this system has general utility in processing diverse materials, the system is configured for sample processing of biological specimens to provide an enriched fraction suitable for detection, enumeration and identification of target cells by appropriate analytical methodologies. The presence and quantities of such target cells in a sample specimen can utilized for screening and detection in disease such as cancer, assessing early stage pre-metastatic cancer, monitoring for disease remission in response to therapy and selection of more effective dose regimens or alternative therapies in case of relapse.

Operator independent programmable sample preparation and analysis system

The methods and reagents described in this invention are used to analyze circulating tumor cells, clusters, fragments, and debris. Analysis is performed with a number of platforms, including flow cytometry and the CELLSPOTTER&#xae; fluorescent microscopy imaging system. Analyzing damaged cells has shown to be important. However, there are two sources of damage: in vivo and in vitro. Damage in vivo occurs by apoptosis, necrosis, or immune response. Damage in vitro occurs during sample acquisition, handling, transport, processing, or analysis. It is therefore desirable to confine, reduce, eliminate, or at least qualify in vitro damage to prevent it from interfering in analysis. Described herein are methods to diagnose, monitor, and screen disease based on circulating rare cells, including malignancy as determined by CTC, clusters, fragments, and debris. Also provided are kits for assaying biological specimens using these methods.

Analysis of circulating tumor cells, fragments, and debris

The methods and reagents described in this invention are used to analyze circulating tumor cells, clusters, fragments, and debris. Analysis is performed with a number of platforms, including flow cytometry and the CellSpotter&#xae; fluorescent microscopy imaging system. Analyzing damaged cells has shown to be important. However, there are two sources of damage: in vivo and in vitro. Damage in vivo occurs by apoptosis, necrosis, or immune response. Damage in vitro occurs during sample acquisition, handling, transport, processing, or analysis. It is therefore desirable to confine, reduce, eliminate, or at least qualify in vitro damage to prevent it from interfering in analysis. Described herein are methods to diagnose, monitor, and screen disease based on circulating rare cells, including malignancy as determined by CTC, clusters, fragments, and debris. Also provided are kits for assaying biological specimens using these methods.

Methods and kits for used as an internal or external control in rare cell analysis are disclosed. A plurality of fluorescently distinct sets of cells is used to define a range to assess the isolation of rare target cells from a sample. Thus, a known number of cells, expressing the surface and intracellular antigens present in the targeted rare cells, are stabilized and modified in such a way that they can be discriminated from the targeted rare cells. In addition, these cells are separated into at least two sets based upon the number. These sets are detectably distinct from each other and provide an upper and lower indication of the detection ability of the rare cell assay.

Labeled cell sets for use as functional controls in rare cell detection assays

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Hatboro, PA, United States of America

Herman Rutner