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HAYWARD, CA, United States

Patent
Advanced Cell Diagnostics, Inc. | Date: 2011-09-20

Disclosed is a method for diagnosing melanoma in a human subject, as well as a method for providing a prognosis to a human subject who is at risk of developing melanoma recurrence, and a method for determining the stage of melanoma in a human subject, comprising the step of determining the level of expression of phosphatase and actin regulator 1 (PHACTR1) gene, or fragments thereof, either alone or in combination with the level of expression of secreted integrin-binding phosphoprotein (SPP1), preferentially expressed antigen in melanoma (PRAME), growth differentiation factor 15 (GDF 15), and chemokine C-X-C motif ligand 10 (CXCL10) genes. Further, the invention relates to a diagnostic kit, comprising at least one substance for detection of the expression of PHACTR1, or fragments thereof, either alone or in combination with the detection of SPP1, PRAME, GDF15, and CXCL10, for the diagnosis or prognosis of melanoma.


Patent
Advanced Cell Diagnostics, Inc. | Date: 2013-05-03

The invention provides an apparatus for securing an object on a frame, wherein the object comprises a surface for displaying a sample. The apparatus can comprise a first clamping member movably mounted on a frame, wherein the first clamping member changes from an open position to a closed position to secure an object on the frame.


The invention relates to methods of categorizing a cervical tissue or cytology sample by performing an in situ hybridization assay using an antisense E6 or E7 probe on a cervical tissue sample, wherein the antisense E6 or E7 probe can simultaneously detect HPV DNA and HPV RNA; detecting the presence of HPV nucleic acid; and categorizing the cervical tissue sample based on HPV nucleic acid expression.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 269.74K | Year: 2015

DESCRIPTION provided by applicant In the US lung cancer will add new cases and cause deaths in Non small cell lung cancer NSCLC accounts for of lung cancer The availability of targeted therapies directed to driver oncogenes such as EGFR mutations and gene fusions e g EML ALK in recent years has transformed the management of NSCLC These advances have also created an unprecedented challenge to conduct multiple molecular testing using limited diagnostic materials In many settings of NSCLC patients present with advanced disease and are simultaneously diagnosed staged and their tumors molecularly tested for targeted therapy using fine needle aspiration FNA derived cytology specimen obtained during endobronchial ultrasound EBUS Liquid based cytology slides especially ThinPrep slides have proven superior to formalin fixed paraffin embedded FFPE cell blocks for assessing ALK gene status by DNA fluorescent in situ hybridization FISH However the number of ThinPrep slides that can be prepared from a typical EBUS FNA specimen is limited usually In order to perform multiple testing an in situ method with multiplexing capability beyond conventional FISH and immunohistochemistry IHC is needed In this Phase I study we propose to leverage the high sensitivity and multiplexing capability of a recently developed RNA in situ hybridization technology RNAscope R to develop a novel companion diagnostic algorithm that can efficiently and accurately detect multiple rare but andquot actionableandquot oncogenic gene fusions ALK ROS RET NTRK and others in NSCLC patients using FNA derived ThinPrep slides PUBLIC HEALTH RELEVANCE The current increasing use of minimally invasive diagnostic procedures in oncology poses a number of challenges to companion diagnostic testing First while the number of molecular targets to be tested is increasing on a regular basis the amount of diagnostic specimen is decreasing Second most of the molecular changes of interest are present only in small subsets of patients Therefore there is an urgent need to develop molecular diagnostic methods that have multiplexing capability beyond conventional fluorescent in situ hybridization FISH and immunohistochemistry IHC yet maintain the benefits of in situ biomarker detection In this Phase I study we propose to leverage the high sensitivity and multiplexing capability of the RNAscope RNA ISH technology to develop a novel companion diagnostic algorithm that can efficiently and accurately detect multiple rare but andquot actionableandquot oncogenic fusions in non small cell lung cancer NSCLC using limited fine needle aspiration FNA derived cytology samples


Patent
Advanced Cell Diagnostics, Inc. | Date: 2011-10-21

Disclosed is a method for in situ detection of one or more target nucleic acids based on a combination of RNAscope method and a general ISH signal amplification method. This new method produces high signal intensity and while keeps low background noise of signal amplification. The result can be consistently reproduced and the method can be easily adopted for routine clinic diagnostic use. Further, the invention relates to a kit, comprising the components of RNAscope assay and a general ISH signal amplification assay, for sensitive detection of one or more target nucleic acids.

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