Navigation Links
Studies Investigate Diagnostic Performance and Reproducibility of Pathwork Diagnostics' Tissue of Origin Test
Date:11/8/2007

SUNNYVALE, Calif., Nov. 8 /PRNewswire/ -- Pathwork Diagnostics, a genomics-based diagnostics company focused on oncology, announced that its Pathwork(TM) Tissue of Origin Test is the focus of two studies featured in poster presentations at this week's 12th Annual Meeting of the Association for Molecular Pathology (November 7-10, Los Angeles). The new genomics-based test is designed to help determine a tumor's origin so that tissue-specific management can begin.

There are an estimated 200,000 cancer patients each year in the United States who may benefit from diagnostic information to determine the tissue of origin for their cancer. One study showed that, in some cases, the primary tumor site is identified only 25 percent of the time using traditional diagnostic tools. National Comprehensive Cancer Network guidelines emphasize the importance of identifying the tissue of origin so that management specific to the primary cancer can begin.

The Pathwork Tissue of Origin Test's proprietary analytics are designed to measure the expression of more than 1600 genes and compare a tumor's genetic "signature" against those of 15 known tissue types. The test uses microarray technology, which enables large numbers of genes to be evaluated at the same time, using the proven, commercially available Affymetrix instrument system.

"This test has the potential to be an effective aid in the diagnosis of cancer patients presenting with poorly differentiated and undifferentiated tumors," concluded Federico Monzon, M.D., Methodist Hospital, Houston, TX, (Poster #ST102, Friday, November 9, 1:00-3:00 PM, Constellation and Olympic Ballroom).

Dr. Monzon's clinical validation study ("Validation of a gene expression-based tissue of origin test applied to poorly differentiated and undifferentiated cancers") evaluated the performance of the Pathwork Tissue of Origin Test in a clinical setting. In the study, specimens of 477 metastatic and poorly differentiated and undifferentiated primary human tumors were obtained. All samples were of known origin (termed reference diagnosis).

Frozen tissue specimens were processed in two laboratories with a recommended protocol for gene expression with the Affymetrix platform. Data were analyzed with the Pathwork Tissue of Origin algorithm and a Tissue of Origin report was generated for each sample. The result was compared to the reference diagnosis to establish the performance characteristics of the Pathwork test. The Tissue of Origin Test results matched the reported origin in 89% of samples tested and provided greater than 92% agreement for at least 8 tissues of origin.

In the second study, Catherine I. Dumur, Ph.D., Virginia Commonwealth University, Richmond, VA, led a group which examined the analytical performance characteristics and reproducibility of the Tissue of Origin Test, "Analytic performance of a microarray-based gene expression test to determine tissue of origin in uncertain primary cancers" (Poster #ST01, Thursday, November 8, 2:30-4:30 PM, Constellation and Olympic Ballroom).

In Dr. Dumur's study, 60 archived tissue specimens from poorly and undifferentiated tumors (metastatic and primary) were analyzed at four laboratories representing a wide range of pre-analytical conditions. Reproducibility was analyzed by cross-wise comparisons of all 4 sites. Cross-laboratory comparisons, performed using a variety of measures, showed highly reproducible results between laboratories. In addition, an average of 93.8% overall concordance between laboratories in terms of final tissue of origin calls was obtained.

"As a result of the study, we concluded that the Pathwork Tissue of Origin Test is a robust assay that produces consistent results in diverse laboratory conditions reflecting the pre-analytical variations found in the everyday clinical practice of molecular diagnostics laboratories," explained Dr. Dumur.

Note: The Pathwork Tissue of Origin Test is not cleared by the FDA for sale in the U.S. It is for Investigational Use Only.

About Pathwork Diagnostics

Pathwork Diagnostics, based in Sunnyvale, California, develops and delivers genomics-based diagnostics that advance cancer care. The company solves unmet clinical needs in oncology by using innovative technology to harness the power of genomics information and apply it in a robust, reproducible and reliable manner. Pathwork Diagnostics plans to deliver FDA-cleared microarray-based diagnostic tests for oncology to the clinical laboratory. The company's initial tests will consist of Pathwork Diagnostics' proprietary analytics and a companion Pathchip(TM) microarray, which runs on the proven Affymetrix instrument system. The company's first test -- the Pathwork(TM) Tissue of Origin Test -- is designed to be an aid in the diagnosis of the tissue of origin in patients with poorly or undifferentiated tumors or metastases.


'/>"/>
SOURCE Pathwork Diagnostics
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Gene Studies of Male-Female Differences Often Flawed
2. Two studies published in the Lancet
3. Study of Studies Finds No Risk to Children From Phthalates in Toys
4. Just Completed Studies Reveal Impact of New Medicare Reimbursement Regulations
5. Studies Prove Exercise Can Heal the Body Mind and Soul
6. Studies Shed New Light on Breast Cancer, Treatment
7. Multi-Year Compendium of Pharmaceutical Case Studies Available from Best Practices, LLC
8. Genomic Health Announces Multiple Studies on Oncotype DX(TM) Presented at 2007 American Society of Clinical Oncology (ASCO) Breast Cancer Symposium
9. Best Practice Database: Complimentary Excerpt of Three Sales Force Excellence Studies
10. Major Pharma Clinical Case Studies From Amgen, AstraZeneca, GSK, Intermune, Cephalon Inc, Sunesis Pharmaceuticals and Dartmouth Medical School During Fall Clinical Focused Programs
11. NIH awards Einstein multimillion dollar grant to extend studies of exceptional longevity
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... ... 27, 2016 , ... With a team of certified experts, ... Aside from its GMP accreditation, Validation Center is also a registered authority of ... and staff. , Validation Center is ISO17025 accredited and only offers its clients ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... ... and clinical outcomes, hosted members and suppliers for its inaugural Member Conference at ... on their mission of elevating the operational health of America’s healthcare providers. , ...
(Date:5/26/2016)... ... 2016 , ... Cardiac arrhythmia is a common complication following ... survival, reports a team of UPMC researchers in the largest study of its ... Thoracic and Cardiovascular Surgery, provide critical information that will hopefully lead to better ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... An April ... American families. , The 550 employees of Sun Health Senior Living (SHSL) ... Aetna that reduces their doctor and prescription copays for the year, while holding the ...
(Date:5/26/2016)... ... ... The Lung Institute has partnered with the Gulfcoast North Area ... at their clinic in downtown Tampa. The class is complimentary for the public. Register ... a free downloadable 4 Week Smoking Cessation Guide for those who are ...
Breaking Medicine News(10 mins):
(Date:5/24/2016)... May 24, 2016 Niederländische ... gebracht, die es Ärzten erlaubt, ihre Expertise weltweit ... MDLinking kombiniert Live Streaming mit einer Instant-Messaging-Funktion und ... kommunizieren. Mediziner in Europa, Afrika, Asien und den ... für die Plattform registriert. Information und ...
(Date:5/24/2016)...   , Study met both ... in , Excellent plus Good ... of the ascending colon   ,      ... announced new positive data from the phase III MORA study for ... litre PEG with ascorbate. The study met both primary endpoints showing ...
(Date:5/24/2016)... 2016  NxStage Medical, Inc. (Nasdaq: NXTM ... renal care, today announced that Jeffrey H. Burbank ... following schedule of investor conferences. Where applicable, a webcast ... http://ir.nxstage.com/ .   ... NY           Friday, June 10, 2016 1:30 p.m. ET ...
Breaking Medicine Technology: