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News Article | November 10, 2016
Site: www.newsmaker.com.au

Cancer is characterized by the growth of abnormal cells that divide uncontrollably and have the ability to infiltrate and destroy normal body tissue. Cancer is triggered by both external factors such as tobacco, chemicals, alcohol, infectious organisms, sun exposure and internal factors such as hormones, inherited gene mutations, immune conditions and abrupt mutations. Cancer can start almost anywhere in the human body and has the ability to spread all over the body. Cancers are majorly solid tumors (tissue masses) and blood cancers (leukemia). There are more than 100 types of cancers such as lung cancer, colorectal, breast, blood cancers, etc. Cancer is the second-leading cause of death in the United States. But survival rates have improved for many types of cancer due to continuous development of screening and treatment procedures. The most common cancer diagnostic methods are biopsy, sentinel node biopsy, endoscopy, blood tests, bone marrow aspiration, Pap test, sputum and bronchial washing analysis, imaging studies, genetic analysis, etc. The diagnosis of cancer involves collection of patient samples such as a cell or tissue or cells’ proteins, DNA, and RNA followed by detection of specific cancer. Cancer diagnostics market is witnessing high growth due to increasing prevalence and incidences of several types of cancers. Major drivers for the global cancer diagnostic market are technologically advanced and increasing point-of-care diagnostics, cost-effective treatment modalities, and personalized medicine. Additionally, increasing persistence to provide best-in-class healthcare services with high accuracy and efficiency towards patient is expected to fuel the global cancer diagnostics market across the globe. However, lack of adequate reimbursement policies for novel technologies and stringent regulatory procedures particularly for United States are the major factors that can hamper the global cancer diagnostics growth over the forecast period. The global cancer diagnostics market has been classified on the basis of product, application, end use and geography. Based on product type, the global cancer diagnostics market is segmented into the following: Based on application type, the global cancer diagnostics market is segmented into the following: Based on end use type, the global cancer diagnostics market is segmented into the following: North America was the key region in global cancer diagnostics market in terms of revenue in 2014, followed by Europe. The first FDA-cleared assay for breast cancer diagnosis was In Vitro Diagnostic Multivariate Index Assays (IVDMIA). The "MammaPrint" and “BluePrint” assays for breast cancer diagnosis and a microarray-based gene expression assay "ColoPrint" for predicting the recurrence of stage II and III colon cancer, has recognized the potential of cancer/tumor profiling in diagnostics and prognosis. This scenario is anticipated to revolutionize the cancer diagnostics companies and boost growth in global cancer diagnostics market in the coming five to 10 years.  By product type, genomic biomarkers are dominating as compared to other product types in global cancer diagnostics market. For instance, GUARDANT360 blood test, next generation sequencing test 'Cologuard', Cobas HPV Test, and myRisk Hereditary Cancer multigene molecular diagnostic test are few examples of genomic biomarkers. By end use, hospitals and diagnostic centres segments held 50% share in the global cancer diagnostic market and the trend is forecast to continue through 2025. The altering regulatory consequences among the high growth countries of Asia Pacific is attracting the leading companies in the global cancer diagnostics market. Key players of cancer diagnostics market are M Genomics Ltd., Abbott Laboratories,  Agena Bioscience Inc., Alere Inc., Astra Biotech GmbH, bioMérieux SA, BioMosaics, Biotype Diagnostic GmbH, Cancer Genetics, Inc., CDx Diagnostics, Celerus Diagnostics, Inc., Cube Dx GmbH, Dako A/S (an gilent company), EntroGen, Inc., Epigenomics AG, Exact Sciences Corporation, GE Healthcare, Genalyte, Inc., GeneCentric Diagnostics, Inc., GeneDx,., Genomic Vision, Genoptix (a Novartis company),  Hologic, Inc., Illumina, Inc., Inform Genomics, Inc., Mayo Medical Laboratories and Mayo Clinic, MBL International Corporation, NanoIVD, Inc., NanoString Technologies, Inc., NewGene Ltd., OncoPlex Diagnostics (OncoPlexDx), Oncospire Genomics, Oxford Cancer Biomarkers Ltd., Oxford Gene Technology, PrognosDx Health, Inc., Provista Diagnostics, Inc., QuantuMDx Group, Quest Diagnostics, Rheonix, Inc., Rosetta Genomics Ltd., Siemens Healthcare Diagnostics, Thermo Fisher Scientific, Inc., Transgenomic, Inc., TrimGen Corporation, TrovaGene, Inc., Ventana Medical Systems, Inc. Getting regulatory approvals for in vitro cancer diagnostics in Europe is easy as compared to United States. So preferably most of the cancer diagnostic companies are launching their new innovative products in Europe and consequently applying for FDA in the United States.


News Article | February 21, 2017
Site: www.businesswire.com

OMAHA, Neb.--(BUSINESS WIRE)--Transgenomic, Inc. (TBIO) (OTCQB: TBIO) today reported that trading in its shares will begin on the OTCQB exchange under the ticker “TBIO” effective at the open of business on February 22, 2017. On February 17, 2017, the Company received written notification from the staff of the Nasdaq Stock Market LLC (“Nasdaq”) that it had determined to delist the Company’s shares from Nasdaq and accordingly, trading in the Company’s shares will be suspended effective at the open of business on February 22, 2017, as a result of the Company no longer meeting certain Nasdaq continued listing requirements. As previously disclosed, Nasdaq had informed Transgenomic that its shares would no longer continue to trade on Nasdaq, unless the Company met the minimum share price and shareholder equity requirements on or before February 19, 2017. Nasdaq will complete the delisting by filing a Form 25 Notification of Delisting with the Securities and Exchange Commission (the “SEC”) after the applicable appeal periods have elapsed. On February 3, 2017, Transgenomic filed a preliminary proxy statement with the SEC with respect to the previously announced merger of its wholly owned subsidiary, New Haven Labs Inc., with Precipio Diagnostics, LLC in a transaction which has been structured, in part, to result in a combined entity that will meet all initial listing standards for the Nasdaq Capital Market. Additionally, the new company that will be created by the merger, and which will be known as Precipio, has applied in advance to Nasdaq to list its shares, and trading on the Nasdaq Capital Market is expected to resume when the merger closes, under the proposed ticker “PRPO”. Transgenomic currently expects that the merger, which is subject to approval of the Transgenomic stockholders and certain other conditions, will close during the second quarter of 2017. Paul Kinnon, President and Chief Executive Officer of Transgenomic, commented, “We are working diligently toward completion of the merger and we are excited about the opportunities the combination will create and believe that the combined company will be well positioned to build on its unique assets in the rapidly growing fields of advanced diagnostics and personalized medicine.” Ilan Danieli, Precipio’s founder and Chief Executive Officer noted, “We look forward to the closing of our merger with Transgenomic so that we can begin the process of integrating our teams, technologies, services and growing this platform. We believe the distinctive strengths of our two companies are complementary and, together, we expect to be a dynamic, growing, value-added player in the rapidly changing healthcare sector.” About Transgenomic Transgenomic, Inc. is a global biotechnology company advancing personalized medicine in oncology and inherited diseases through advanced diagnostic technologies, such as its revolutionary ICE COLD-PCR, which enables use of liquid biopsies for mutation detection. The company also provides specialized clinical and research services to biopharmaceutical companies developing targeted therapies. Transgenomic’s diagnostic technologies are designed to improve medical diagnoses and patient outcomes. About Precipio Precipio Diagnostics has built a platform to harness the intellect, expertise and technology developed within academia, delivering quality diagnostic information to physicians and patients worldwide. Through its collaborations with world-class academic institutions specializing in cancer research, diagnostics and treatment, and its experience delivering quality service, Precipio Diagnostics offers a new standard of diagnostic accuracy enabling the highest level of patient care. For more information, visit www.precipiodx.com. Forward-Looking Statements Certain statements in this press release constitute “forward-looking statements” of Transgenomic within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to management's current views and estimates of future economic circumstances, industry conditions, company performance and financial results, including the ability of the Company to grow its involvement in the diagnostic products and services markets, expectations regarding new clients, projects and prospects, and MX-ICP’s ability to accelerate the Company’s growth and generate revenue. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic's filings with the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law. In connection with the proposed merger, Transgenomic has filed with the SEC a preliminary proxy statement relating to the approval of the merger agreement. The information in the preliminary proxy statement is not complete and may be changed. The preliminary proxy statement and this press release are not offers to sell Transgenomic securities and are not soliciting an offer to buy Transgenomic securities in any state where the offer and sale is not permitted. The definitive proxy statement will be mailed to stockholders of Transgenomic. TRANSGENOMIC URGES INVESTORS AND SECURITY HOLDERS TO READ THE DEFINITIVE PROXY STATEMENT AND OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the definitive proxy statement (when available) and other documents filed with the SEC by Transgenomic through the web site maintained by the SEC at www.sec.gov. Free copies of the definitive proxy statement (when available) and other documents filed with the SEC can also be obtained on Transgenomic’s website at www.transgenomic.com/ir/investor-information. Transgenomic and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Transgenomic in connection with the merger. Information about the directors and executive officers of Transgenomic is set forth in Transgenomic’s proxy statement filed with the SEC on April 29, 2016. Additional information regarding the interests of these participants and other persons who may be deemed participants in the merger may be obtained by reading the definitive proxy statement regarding the proposed transaction when it becomes available.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 200.00K | Year: 2013

DESCRIPTION (provided by applicant): Cancers develop from the life-long accumulation of critical somatic mutations due to DNA-damaging agents that lead to cells transforming into tumor-forming cells. These low-level tumor-associated somatic DNA mutations can have profound implications for development of metastasis, prognosis, choice of treatment, follow-up or early cancer detection. Unless they are effectively detected, these low-level mutations can misinform patient management decisions or become missed opportunities for personalized medicine. Widely-used technologies such as sequencing are not sensitive enough to detect these mutations when they are at very low percentages compared to normal DNA. Likewise the next generation sequencing technologies (NGS)are promising technology advances that can effectively detect prevalent somatic mutations in targeted gene panels; however due to the limited quantity of DNA in most patient samples and the abundance of normal DNA when analyzing blood, NGS 'loses steam' and its integration with clinical practice is problematic. For mutations at an abundance of ~2-5% or below, NGS generates false positives ('noise') independent of sequencing depth; yet these are often the clinically relevant mutations causing resistance todrug treatments. Commercial sample preparation kits for targeted re-sequencing of cancer gene panels have emerged1-3, however they are uniformly unable to detect mutations below a 2% abundance level. Thus, while targeted re-sequencing provides an opportunity for integration of NGS with clinical oncology, the technology is ineffective in detecting DNA mutations in heterogeneous cancers or in circulating DNA. We intend to use COLD-PCR, a new method that enriches unknown mutation-containing sequences over wild-type, normal alleles during PCR amplification. We have been able to show sequencing of mutations down to 0.02% abundance. However in its current form this method only can be used with single amplicon per reaction, limiting its efficient combination withNGS. In this project we propose a simple and powerful modification that enables COLD-PCR to be applied on hundreds or thousands of DNA targets in a single reaction, thus enabling mutation enrichment in cancer- specific gene panels prior to NGS. This wouldconvert the rare mutations to high abundance mutations, overcoming the 'noise' and avoid the costly need for repeated sequence reads during NGS. This method, known as temperature-tolerant-COLD-PCR (TT-COLD-PCR), will be developed into kits for cancer-specific gene panels, to magnify rare mutations in multiple DNA targets thus enabling expanded application of targeted re-sequencing for heterogeneous cancers or circulating DNA. This project meets one of the stated aims of the NCI to support the developmentof new methods of diagnosis for the detection, discovery and validation of biomarkers for cancer detection, diagnosis and prognosis. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: The selection of the best available cancer treatment is, in many instances, dependent on the genetic profile of the patient's cancer cells. This can be difficult to determine when there is limited availability of tumor DNA, as when analyzing blood, when obscured by far more abundant healthy cell DNA and when many DNAtargets need to be analyzed. This project aims to develop a multiplexed DNA analysis technique that enriches low abundance cancer mutations in clinical specimens such as blood to improve cancer treatment selection.


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 100.00K | Year: 2012

DESCRIPTION (provided by applicant): Ninety percent of all pancreatic cancers are pancreatic ductal adenocarcinoma (PDAC). PDAC diagnosis is difficult, usually occurring in the late stages of disease. Patients with these advanced tumors typically respondpoorly to therapy. Post diagnosis, median survival is 6 months and the five-year survival rate is lt 4%. Five-year survival is lt 1% for those with advanced cancer. Progression to advanced disease occurs with few, if any, symptoms but studies have shown that there is a long period of time during which early detection may be possible. There appears to be a timeline for detection of specific biomarkers during the disease's development: (1) in Stage 1a, mutations in K-RAS occur early when there are minimal visible cytological, morphological or symptomatic changes; (2) in Stages1b and 2, additional genetic mutations occur that lead to Her-2 overexpression and p16 inactivation; (3) in Stage 3, mutations occur in the TP53, DPC4, and BRCA2 genes. The lack of symptoms in the early stages means that patients go undetected until the later stages when treatments may not be as effective. It is not feasible to routinely test pancreatic tissues for markers of early disease and it has been difficult to identify disease markers in plasma, serum and/or urine that might enable early disease detection. The discovery of the accumulated mutations in many human pancreatic tumors, specifically in K-RAS and TP53, has suggested that pancreatic cancer animal models are useful for the study of disease development. These mouse models will be used to test the application of Ice COLD-PCR to the high sensitive detection of K- RAS and Trp53 mutations in urine and blood. Further, this model system will allow the study of pancreatitis- relatedprogression to pancreatic cancer stage 1 in a mutant K-RAS background. Pancreatitis will be induced in these mice models which will enable a time-line investigation of early detection of K-RAS and Trp53 mutations in murine samples. The method will be further validated in several tissues from well-characterized human pancreatic autopsy samples, including pancreas, blood and urine. If promising results are obtained from these Phase I studies, a Phase II STTR application will include more comprehensive studiesof Ice COLD-PCR detection of DNA mutations associated with early and late stage pancreatic cancer in humans. This could ultimately lead to a simple, highly sensitive diagnostic assay for the early detection of pancreatic ductal adenocarcinoma. PUBLIC HEALTH RELEVANCE: Pancreatic cancer is difficult to diagnose at an early stage. In the disease's late stage response to therapy is poor with an average survival of 6 months after diagnosis and a five-year survival rate of less than 4%. We aim to develop a highly sensitive genetic test that can detect pancreatic cancer biomarkers in blood or urine, enabling much earlier diagnosis and more effective treatment.


The present invention relates to a polymorphic MRP-1 polynucleotide, genes or vectors comprising the polynucleotides and a host cell genetically engineered with the polynucleotide or gene. Also provided are methods for producing molecular variant polypeptides, cells capable of expressing a molecular variant polypeptide and a polypeptide encoded by the polynucleotide or the gene or obtainable by the method or cells produced herein. Also provided is an antibody to the polypeptide, a transgenic animal, and a solid support comprising one or a plurality of the provided polynucleotides, genes, vectors, polypeptides, antibodies or host cells. Furthermore, methods of identifying a polymorphism, identifying and obtaining a pro-drug or drug or an inhibitor are also provided. In addition, the invention relates to methods for producing a pharmaceutical composition, diagnosing a disease and detection of the polynucleotide. Furthermore, provided herein are uses of the polynucleotides, genes, vectors, polypeptides or antibodies herein.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase II | Award Amount: 773.51K | Year: 2016

DESCRIPTION provided by applicant Low level tumor associated somatic DNA mutations can have profound implications for development of metastasis prognosis choice of treatment follow up or early cancer detection Unless they are effectively detected these low level mutations can misinform patient management decisions or become missed opportunities for personalized medicine Widely used technologies such as sequencing are not sensitive enough to detect these mutations when they are at very low percentages compared to normal DNA Likewise the next generation sequencing technologies NGS are promising technology advances that can effectively detect prevalent somatic mutations in targeted gene panels however due to the limited quantity of DNA in most patient samples and the abundance of normal DNA when analyzing blood NGS andapos loses steamandapos and its integration with clinical practice is problematic For mutations at an abundance of or below NGS generates false positives `noiseandapos independent of sequencing depth yet these are often the clinically relevant mutations causing resistance to drug treatments Commercial sample preparation kits for targeted re sequencing of cancer gene panels have emerged however they are uniformly unable to detect mutations below a abundance level Thus while targeted re sequencing provides an opportunity for integration of NGS with clinical oncology the technology is ineffective in detecting DNA mutations in circulating DNA urine or heterogeneous cancers We intend to use COLD PCR a recently developed method that enriches unknown mutation containing sequences over wild type normal alleles during PCR amplification In previous work we showed COLD PCR NGS based sequencing for mutations down to abundance However COLD PCR was only applicable with a single amplicon per reaction limiting its efficient combination with NGS This STTR proposes a simple and powerful modification that enables COLD PCR to be applied to hundreds or thousands of DNA targets in a single reaction thus enabling mutation enrichment in disease specific gene panels prior to NGS The new approach temperature tolerant COLD PCR TT COLD PCR converts the rare mutations to high abundance mutations overcoming the `noiseandapos and avoiding the costly need for repeated sequence reads during NGS In Phase I we obtained proof of principle for TT COLD PCR In Phase II TT COLD PCR will be developed into kits for cancer specific gene panels to magnify rare mutations in multiple DNA targets thus enabling expanded application of targeted re sequencing for heterogeneous cancers or circulating DNA This project meets one of the aims of the NCI to support the development of new methods of diagnosis for the detection discovery and validation of biomarkers for cancer detection diagnosis and prognosis PUBLIC HEALTH RELEVANCE Screening of patientsandapos tumors for genetic alterations over many genes in a minimally invasive rapid and cost effective manner is a significant challenge that must be fulfilled in order to realize the promise of individualized cancer treatment Although major advances have been made there is still a significant gap in technology that prevents molecular profiling from repeated blood collections `liquid biopsiesandapos This STTR project provides an answer to this challenge by employing a new technology TT COLD PCR in combination with Next Generation Sequencing This novel approach overcomes technical limitations and enables reliable mutation screening in multiple genes simultaneously in bodily fluids or surgical cancer samples from individual patients In view of the fundamental role of mutations in causing cancer and modulating tumor response to drug treatment this project has significant implications for public health


Patent
Transgenomic, Inc. | Date: 2014-01-10

The invention is based, at least in part, on the observation that the presence of particular biomarkers, e.g., particular mutations in any of the KCNQ1, KCNH2, SCN5A, KCNE1 and KCNE2 genes as identified in Tables 1-5 (and, in particular, those identified with an asterisk), is associated with Long QT Syndrome (LQTS).


Patent
Transgenomic, Inc. | Date: 2013-03-15

Methods of using polymerase chain reactions to enrich a target sequence in a sample containing reference sequences and target sequences having high homology and amplifiable by the same primer pair are provided herein. In particular the methods provide a robust means to improve the fold enrichment of the target sequence and minimize reaction-to-reaction, well-to-well and run-to-run variations in the enrichment methods.


Patent
Transgenomic, Inc. | Date: 2012-02-28

Methods and kits for sequencing a target DNA sequence in a sample having a related reference sequence are provided herein. In particular, kits and methods for sequencing cancer and cancer therapy associated mutations are described. Also provided are kits and methods for detecting mitochondrial mutations and for differentiating between closely related viral strains.


OMAHA, Neb.--(BUSINESS WIRE)--Transgenomic, Inc. (NASDAQ:TBIO), today announced that the company will hold its Third Quarter 2015 Financial Results and Business Update Conference Call on Thursday, November 12, 2015 at 5:00 PM ET. The company will present an overview of financial results for the third quarter in a press release issued after the market close that day. To participate in the call, dial 866-952-8561 from the U.S. and Canada or 785-424-1883 from international locations and enter conference ID: TRANS. The call will be webcast live and can be accessed at https://www.webcaster4.com/Webcast/Page/1139/11743, which is also available at the Investor Relations (IR) section of Transgenomic’s website. A replay will be available for two weeks beginning approximately two hours after the call’s conclusion, until 11:59 PM ET November 26, 2015. To access the replay, dial 800-839-3616 (domestic) or 402-220-2974 (international). The conference call will also be archived at the IR section of the company’s website. About Transgenomic, Inc. Transgenomic, Inc. is a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through advanced diagnostic technologies, such as its revolutionary ICE COLD-PCR™ and its unique genetic tests provided through its Patient Testing business. Transgenomic also provides specialized clinical and research services to biopharmaceutical companies developing targeted therapies and sells equipment, reagents and other consumables for applications in molecular testing and cytogenetics. Transgenomic’s diagnostic technologies are designed to improve medical diagnoses and patient outcomes.

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