Immunivest Corporation

Veridex, Lcc

Duke University

Janssen Diagnostics, LLC

Menarini Silicon Biosystems, Inc.

Other

Menarini Silicon Biosystems S.p.a.

Scripps Health

Galla Chandra Rao

Paul A Liberti

Leon W M M Terstappen

Mark Carle Connelly

Steven Gross

Jonathan W Uhr

Herman Rutner

Emilian V Racila

Tor Alden

Leon W Terstappen

Mariano A Garcia-Blanco

Brad Foulk

Michael Kagan

Jerry Prohaska

Shawn Mark O'Hara

Madeline I Repollet

Denis Smirnov

Andrew J Armstrong

Joseph N Chiarappa

Christopher Larson

Karl Nielsen

Rhonda L Bitting

Dhanesh I Gohel

Brian P Feeley

Carrie Morano

Marielena Mata

Ellen S Church

Gerald V Doyle

Madeline Repollet

Leon Terstappen

Mark Connelly

Samir Damani

Eric Topol

Mark C Connelly

Melissa Hermann

Shawn Mark O'hara

Leon Wmm Terstappen

Provided are methods for detecting or isolating circulating tumor cells (CTCs) in a subject. The methods may include detecting the expression of at least one epithelial mesenchymal transition (EMT) biomarker. Further provided are kits for detecting or isolating CTCs. The kits may include antibodies to at least one EMT biomarker. Further provided are methods of predicting the responsiveness of a subject to a cancer drug, methods of targeting delivery of a cancer drug in a subject, methods of providing a cancer prognosis to a subject, and methods for following the progress of cancer in a subject.

Method of isolating circulating tumor cells

The disclosed invention includes methods and kits for the removal of white blood cells from samples of immunomagnetically enriched rare cells by treating the sample with a leukocyte marker conjugated to a hapten which adheres to the white blood cells and treating the resulting product with a second medium that adheres to the hapten of the white blood cells that are labeled with the leukocyte marker conjugated to hapten and removing the labeled white blood cells.

Molecular characterization of circulating tumor cells

The invention includes methods for isolating circulating multiple myeloma cells as well as method of treating patients suspected of having diseases of abnormal plasma cells.

Assay to capture and detect circulating multiple myeloma cells from blood

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

Elevated number of Circulating Endothelial Cells (CEC) have been implicated in disease conditions associated with the formation or destruction of blood vessels such as acute coronary syndrome, thrombocytopenic purpura, sickle cell disease, sepsis, lupus, nephrotic syndromes, rejection of organ transplants, surgical trauma and cancer. This invention provides a method for assessing the levels of CEC which vary between different studies using a sensitive enrichment, imaging, and enumberation analysis. CD146 is one of the most specific endothelium-associated cell-surface antigens which can be used in image cytometry. CEC analysis provides an essential tool in prognostic/diagnostic evaluation in the clinic.

Method for assessing disease states by profile analysis of isolated circulating endothelial cells

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.

An improved cartridge for holding a fluid sample with a small volume is disclosed herein. The cartridge has a test chamber and a vestibule through which the test fluids are inserted into the test chamber. Improved grips are flared-out to aid manipulation. The handle portion is reinforced to prevent flexing, and a prefabricated trough along the edge of the land surface prevents introduction of the adhesive into the region for analysis. The cartridge has a stopper having a dual sealing mechanism, which seals the test chamber inlet between the vestibule and the test chamber, and the mouth of the vestibule so that when the stopper is in place, the test chamber is closed to the admission of air or other contaminants. The vestibule is similarly closed against escape of the overflow from the test chamber. The stopper is composed of a single elastomer. An improved locking mechanism has two flexible walls on either side of the handhold that locks into their respective keepers on the cartridge to provide a secure lock. Additionally, an improved method for loading the cartridge allows for an even distribution of magnetically responsive particles contained within a fluid sample to be viewed in an array through the optically clear land surface portion of the cartridge.

Cartridge for containing a specimen sample for optical analysis

A highly sensitive assay is disclosed which combines immunomagnetic enrichment with multiparameter flow cytometric and immunocytochemical analysis to detect, enumerate and characterize carcinoma cells in the blood. The assay can detect one epithelial cell or less in 1 ml of blood and has a greater sensitivity than conventional PCR or immunohistochemistry by 1-2 orders of magnitude. In addition, the assay facilitates the biological characterization and staging of carcinoma cells.

Methods and reagents for the rapid and efficient isolation of circulating cancer cells

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

Upon a cartridge for containing a specimen sample for optical analysis

Apparatus and methods are disclosed which facilitate immobilization of magnetically labelled particulate entities, e.g., cells, preferably in a defined pattern, on a collection surface via binding between specific binding pair members, as an aid to particle analysis.

Apparatus and methods for capture and analysis of particulate entities

Compositions and methods are disclosed which enhance the microscopic observation and analysis of biological entities such as cells, bacteria and viruses by eliminating interfering magnetic clusters created by naturally occurring aggregators of colloidal magnetic particles. Additionally means for significantly enhancing the magnetic isolation of low antigen density target cells from biological samples are disclosed.

Increased separation efficiency via controlled aggregation of magnetic nanoparticles

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Princeton Junction, NJ, United States of America

Galla Chandra Rao