Category Archives: Pharmacogenomics

By Brian Marckx, CFA

Q3 2012 RESULTS

Transgenomic (OTC Markets:TBIO) reported financial results for Q3 ending September 30, 2012 on November 8th. Revenue fell just over 4% yoy and was well below our estimate due to relatively disappointing numbers from the Pharmacogenomics and Instruments/Diagnostics segments. While Clinical Lab revenue was dead-on with our $4.5 million estimate, the 10% yoy growth in this segment was more than offset by a very poor showing in Pharmacogenomics ($220k, -60% yoy) and Instruments ($3.2 million, -12% yoy).

As a reminder, Pharmacogenomics activity can be highly variable q-to-q, largely dependent on customer directives and not in direct control of TBIO which makes forecasting this line difficult on a short-term basis. Nonetheless Pharmacogenomics revenue in aggregate has disappointed over the first nine months of the year - which we think relates at least in part to longer than anticipated timelines (and potentially delays) of TBIO's phase III clinical trial customer(s). TBIO is still awaiting the green-light from a pharma customer to commence processing for a phase III trial - our model had assumed this work would have already commenced - we are now pushing this assumption and the related revenue back to 2013.

Relative to the Instruments/Diagnostics business, management noted that while they sold more instruments in the quarter compared to the year earlier period, revenue was significantly softer as the majority were sold through Menarini, their European distributor (at a lower average price point relative to the year earlier period which were mostly non-distributor sales). Going forward we continue to expect bioconsumables to be the major revenue driver of the Diagnostics business, particularly with the launch of several cancer marker kits using ICE COLD PCR which should begin to show a meaningful contribution in 2013.

The quarter did have some important positive highlights, namely the ScoliScore acquisition and new collaborations with ICE COLD PCR (with NYU and Univ of Nebraska). Management also noted that C-GAAP, TBIO's Plavix response test, has seen strong physician interest and was a substantial contributor to the 10% growth in Clinical Lab revenues. ScoliScore, as we noted in our 8/9/12 Investor Note (see below), looks like a very solid addition to TBIO's Clinical Lab business and one which we think will make a meaningful top and bottom line impact as early as next year.

The collaboration with NYU's Langone Medical Center involves the use of ICE COLD PCR in the detection of mutations in the blood related to non-small cell lung cancer and response to existing a new therapies. Similar to the collaboration with the MD Anderson Cancer Center (Univ of Texas), the NYU study will focus on circulating tumor cells (CTCs) and use TBIO's CTC capture ScreenCell devices. The collaboration with the University of Nebraska Medical Center involves the use of ICE COLD PCR in the early detection of pancreatic cancer and is being funded by a $100k NIH grant awarded to TBIO which was announced in August. The project could result in a diagnostic test for early stage pancreatic cancer which is almost always fatal if not caught early.

Revenue

Q3 revenue was $7.9 million, down 4% y-o-y and $1.1 million (13%) less than our $9.0 million estimate. The difference came from a $555k variance ($220k A vs. $775k E) in Pharmacogenomics revenue and a $607k variance ($3.2 million A vs. $3.8 million E) in Instruments/Diagnostics with Clinical Lab revenue in-line with our $4.5 million estimate.

Gross Margin

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ScoliScore/C-GAAP Should Drive Clinical Lab Revs in 2013

Biomarkers For Psychiatric Disorders
ll4.me Biomarkers For Psychiatric Disorders Blood and Brain Gene Expression in Major Psychiatric Disorders: A Search for Biomarkers.- Biomarkers in Schizophrenia.- Proteomic strategies for biomarker discovery from differential expression to isoforms to pathways.- Schizophrenia Biomarkers: a means to advance the disease understanding, diagnosis and treatment.- RNA Biomarkers in Schizophrenia.- Metabolomics: a global biochemical approach to the discovery of biomarkers for psychiatric disorders.- Animal models for schizophrenia a brief overview.- Synaptoproteomics of existing and new animal models of depression.- Animal Models for Anxiety Disorders.- Animal Models of affective behaviors and drug addiction.- Neuroimaging biomarkers in schizophrenia.- Sleep EEG provides biomarkers in depression.- Strategies to identify biomarkers for depression.- Pharmacogenetics of antidepressant response.- Perspectives for an integrated biomarker approach to drug discovery and development.- Hunting for peripheral biomarkers to support drug development in psychiatry.- Biomarkers for the development of antidepressant and anxiolytic drugs.- DNA biomarkers for pharmacogenomics and personalized medicine.- Biological modeling in the discovery and validation of cognitive dysfunctions biomarkers. EAN/ISBN : 9780387792514 Publisher(s): Springer, Berlin, Springer US Discussed keywords: Neurologie Format: ePub/PDF Author(s): Turck, Chris W. Blood and Brain Gene Expression in Major Psychiatric Disorders ...From:judybruno986Views:0 0ratingsTime:00:13More inPeople Blogs

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Biomarkers For Psychiatric Disorders - Video

FARMINGTON, Conn., Nov. 6, 2012 /PRNewswire-iReach/ -- Four innovating life science fields to keep an eye on include blood banking, spectrometry, anticoagulants, and cell and tissue culture. Thanks to an aging population and a steep increase in healthcare expenditures among other trends, these markets are on the rise.

(Photo: http://photos.prnewswire.com/prnh/20121106/CG07120)

Global Information Inc (GII) presents four innovative life science market research reports from our premium research partner Global Industry Analysts, Inc. These global strategic business reports provide market forecasts, profile key companies and players, and review mergers, acquisitions and other strategic industry activities related to the dynamic markets for spectrometers, cell and tissue cultures, anticoagulants and blood banking.

Spectrometers and Spectrophoto/Fluorometers

Spectroscopic instruments are the swiss army knife of laboratories they perform diverse tasks such as monitoring processes, identifying compounds and elucidating chemical structures. Driven by rising sales of instrument systems by laboratories, the market for spectroscopy instruments recovered in 2010 and experienced a strong resurgence in 2011 and is project to reach $18.4 billion by the year 2018.

Developed markets such as the United States, Europe and Japan account for a predominant share of the global market for spectrometers and spectrophoto/fluorometers. Despite the continued dominance of developed regions, emerging economies specifically in Asia-Pacific, such as India and China, and Latin America are expected to offer newer opportunities owing to the different economics as well as application needs.

In the long run, demand from industries such as metals, chemicals and automotive is expected to continue driving growth in the spectroscopy market. Advancements in the areas of drug discovery and development, metabolomics, pharmacogenomics, and expanded application markets bode well for the future of spectroscopy market. Above average demand is also expected from security and defense industries; research targeted at discovery and use of new materials as well as continued growth in applications suitable for use in the life sciences market. Advanced spectrometers of the future will target the emerging demands of areas such as mineralogy, medicine, environment, pharmaceuticals and biochemistry.

An Executive Summary for this report and free sample pages from the full document are available at http://www.giiresearch.com/report/go134266-spectrometers.html

Cell/Tissue Culture Supplies

The global market for Cell/Tissue Culture Supplies is projected to reach US$5.6 billion by 2018, driven by advances in biotechnology and life science research coupled with broader range of application areas. Going forward, the market for Cell/Tissue Culture Supplies is expected to grow at an impressive pace, fueled by heightened interest in biopharmaceutical therapeutics, human and veterinary vaccine applications, and growing success of industrial biopharmaceuticals.

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Global Market for Blood Banking and Blood Products Projected to reach $43 billion by 2018; Spectrometers and ...

LOS ANGELES, Nov. 5, 2012 /PRNewswire/ --Response Genetics, Inc. (RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, announced today the launch of testing for ROS1 gene rearrangements. Recently, the Massachusetts General Hospital Cancer Center ("MGH") published studies showing that ROS1 driven tumors are sensitive to the FDA approved drug XALKORI1 (crizotinib)2 to treat non-small-cell lung cancer ("NSCLC") patients with ALK gene rearrangements. Tumors driven by rearrangements in the ROS1 gene represent an additional 1 to 2 percent of patients who may be candidates for crizotinib therapy.3 The company will offer both fluorescence in situ hybridization ("FISH") and polymerase chain reaction ("PCR") based ROS1 translocation testing.

"We are pleased to add ROS1 to our growing test menu," said Thomas Bologna, chairman and CEO of Response Genetics. "We believe the dual option of FISH and PCR represent a unique offering and is consistent with our Leave No Stone Unturned program whereby we go to great lengths to help patients receive optimal therapy. While FISH is the technology that has been used for ROS1 to date, PCR has the advantage of providing additional information about the variant found, information that may be useful for evaluating response and resistance mechanisms.This promising new marker is now readily available to pathologists and oncologists seeking fast turnaround time and utilizes the company's proprietary methods that enable results on very small biopsies including fine needle aspirates."

ROS1 supplements the company's recently introduced Leave No Stone Unturned program, in which patients whose tumors test negative for the ALK Break Apart FISH assay receive follow-up ALK testing using the company's proprietary EML4-ALK RT-PCR-based assay at minimal additional cost. With the addition of ROS1, ordering clinicians can now make a more complete evaluation of each of their NSCLC patients as candidates for crizotinib therapy.

1 XALKORI is a registered trademark of Pfizer, Inc. 2 Bergethon et. al. "ROS1 rearrangements define a unique molecular class of lung cancers." Journal of Clinical Oncology 2012 Mar 10;30(8):863-70. Epub 2012 Jan 3. 3 Ibid

About Response Genetics, Inc.

Response Genetics, Inc. (the "Company") is a CLIA-certified clinical laboratory focused on the development and sale of molecular diagnostic tests for cancer. The Company's technologies enable extraction and analysis of genetic information derived from tumor cells stored as formalin-fixed and paraffin-embedded specimens. The Company's principal customers include oncologists and pathologists. In addition to diagnostic testing services, the Company generates revenue from the sale of its proprietary analytical pharmacogenomics testing services of clinical-trial specimens to the pharmaceutical industry. The Company's headquarters is located in Los Angeles, California. For more information, please visit http://www.responsegenetics.com.

Forward-Looking Statement Notice

Except for the historical information contained herein, this press release and the statements of representatives of the Company related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995.

Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions, such as the ability of the Company to continue to provide clinical testing services to the medical community, to continue to expand its sales force, to continue to build its digital pathology initiative, to attract and retain qualified management, to strengthen marketing capabilities, to expand the suite of ResponseDX products, to continue to provide clinical trial support to pharmaceutical clients, to enter into new collaborations with pharmaceutical clients, to enter into areas of companion diagnostics, and to continue to execute on its business strategy and operations, to continue to analyze cancer samples, the potential for using the results of this research to develop diagnostic tests for cancer, the usefulness of genetic information to tailor treatment to patients, and other statements identified by words such as "project," "may," "could," "would," "should," "believe," "expect," "anticipate," "estimate," "intend," "plan" or similar expressions.

These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities Exchange Commission. Actual results, including, without limitation, actual sales results, if any, or the application of funds, may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by law.

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Response Genetics, Inc. to Offer ROS1 Testing for Lung Cancer

Monday

Job Search 101: Free series hosted by Christ Centered Jobs Ministry. Mondays, Nov. 5, 12, 19 and 26, 9:30 a.m.-noon, Living Word Lutheran Church, 3700 South Mason Road, Katy. Information: Selina Ponniah, selinapon@gmail.com, 281-352-4712 or Jean Marie Huntington, dbhuntington@consolidated.net, 281-693-9764.

Introduction to Microsoft Power Point: Class hosted by Leisure Learning Unlimited. 6:20-9:30 p.m., 2990 Richmond, sixth floor. Cost: $169. Information: http://www.llu.com or 713-529-4414.

Tuesday

The After Hours Network: Meeting. 6-8 p.m., Little Napoli Italian Cuisine, 6445 Westheimer. Speaker: Robert Hinsley. Topic: How to beat the credit card sharks. Cost: $15. Information: http://www.afterhoursnetwork.com.

Bio/Medical Technology Club of Houston: Monthly breakfast meeting. 7-8:30 a.m., Rotary House International, 1600 Holcombe. Speaker: Kevin Rosenblatt, M.D., Ph.D., UTHealth. Topic: Cancer Companion Diagnostics and Pharmacogenomics Testing for Predicting Patient Response to Therapeutics. Cost: $25-$40. Information: Deborah Mansfield, 713-201-4378.

Applications Principles and Intro to Windows: Class hosted by Leisure Learning Unlimited. 9:30 a.m.-5 p.m., 2990 Richmond, sixth floor. Cost: $99. Information: http://www.llu.com or 713-529-4414.

Wednesday

Services Cooperative Association - Houston CrossRoads Business Building Breakfast: 7:15-8:30 a.m., H.E.S.S. Club, 5430 Westheimer. Cost: $22-$30. Information: http://www.servicesca.org/crossroads.htm.

The Parkway Business Partners Chapter of BNI: Meeting. 7:15-9 a.m., Willow Fork Country Club, 21055 Westheimer Parkway, Katy. Speaker: Tom McCarty of Five Star Inspection Service. Information: Chris, 832-252-9413.

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Metamark Genetics, Inc., a privately held, oncology-focused molecular diagnostics company, announced today that it has closed a $13 million series B financing led by current and new private investors. The proceeds from this round will enable the company to further refine its novel, protein-based prostate cancer prognostic tests and complete final clinical validation work. The company is developing two separate prognostic tests. The first is designed to use prostate cancer biopsy tissue to help physicians more accurately determine if patients have a slow-growing or aggressive form of prostate cancer, thereby improving treatment decisions. The second is designed to predict the longer-term course of disease.

This new funding comes on the heels of Metamark successfully completing important proof-of-concept work last spring, said Kenneth Weg, Metamark co-founder and founding chairman of the board of directors. This enables us to proceed with diagnostic and drug target research at an accelerated rate and moves us closer to our goal of achieving commercialization of the Metamark prostate cancer test.

Leadership and board appointments

In conjunction with closing the financing, the company announced changes to the board of directors and the resignation of Mark Straley as president and CEO. Straley resigned to pursue other opportunities and Metamark is conducting a search for a new CEO to lead the company into commercialization and further development.

Michael Kauffman, M.D., Ph.D., joined the Metamark Genetics board of directors and will serve as interim executive director until a new company president and CEO is appointed. Kauffman was vice president of medicine and an early employee at Millennium Predictive Medicine, the diagnostics and pharmacogenomics arm of Millennium Pharmaceuticals Inc. where he co-led collaborations with Becton Dickinson and Bristol-Myers Squibb. More recently, Dr. Kauffman co-founded Karyopharm Therapeutics, a pharmaceutical company developing novel oncology drugs. He was previously chief medical officer of Proteolix Pharmaceuticals and Onyx Pharmaceuticals Inc., where he oversaw the clinical development of carfilzomib. He received his M.D. and Ph.D. from Johns Hopkins Medical School and is board certified in internal medicine.

Greg Critchfield, M.D., M.S., was appointed as lead director of the board. Dr. Critchfield has served on the Metamark board since September 2010. Previously he served as president and board member of Myriad Genetic Laboratories, Inc., the diagnostic subsidiary of Myriad Genetics, Inc., where he was responsible for building scientific, medical, and commercial capabilities and launching seven novel molecular diagnostic products across a variety of technology platforms. Prior to Myriad, he served as chief medical and science officer with responsibility for science, medicine, and innovation at Corning Clinical Laboratories, which later became Quest Diagnostics, Inc. Dr. Critchfield received a bachelor's degree in Microbiology with a minor in Chemistry from Brigham Young University, a M.D. degree from the University of Utah, and a master's degree in Biophysical Sciences at the University of Minnesota. He currently serves as CEO of Sera Prognostics, Inc., and is an independent director of a number of innovative life sciences companies.

Commenting on the leadership changes, Dr. Critchfield stated, Mark has led the company to achieve critical clinical and commercial milestones and we thank him for his contributions and wish him the very best with his future endeavors. He continued, During this time of transition, we are pleased to have Kens continued leadership on our board. He has served as board chairman since the company was formed and has been a rallying foundation for the company. We also feel fortunate to have an individual of Michaels talents and accomplishments serve in this interim leadership capacity as we complete validation of the strong clinical diagnostics foundation built by the Metamark Founders and employees.

About Metamark Genetics, Inc.

Metamark is a privately held oncology company focused on the development of molecular function-based prognostic assays for early staged cancers. The MetamarkDx Prognostic Assays under development are based on Metamarks proprietary Prognosis Determinants, genes discovered through leading edge cancer research and demonstrated to play a causal role in promoting tumor progression and spread. For further information, please visit the companys website at http://www.metamarkgenetics.com.

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Metamark Genetics Completes $13 Million Series B Financing; Announces Leadership Changes