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:10/13/2017)... NJ (PRWEB) , ... October 13, 2017 , ... Global ... at scenic Alexandria Park in Milford, NJ. This free event, sponsored by Global ... physical activity. The fun run is geared towards children of all ages; it ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the ... “America On The Brink” is the creation of published author, William Nowers. Captain ... As a WWII veteran, he spent thirty years in the Navy. Following his ...
(Date:10/12/2017)... CITY, Fla. (PRWEB) , ... October 12, 2017 , ... ... cold therapy products, announced today the introduction of an innovative new design of the ... multipurpose pad so you get maximum comfort while controlling your pain while using cold ...
(Date:10/12/2017)... ... 12, 2017 , ... HMP , a leader in healthcare events and ... Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during the Eddie ... annual award competition recognizes editorial and design excellence across a range of sectors. This ...
(Date:10/12/2017)... ... October 12, 2017 , ... In the United States, ... In some states—like New York, New Jersey, Massachusetts, Texas, Virginia, Connecticut, and California—the ... have extremely low property-tax rates, which contributes to the relatively lower cost of ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/7/2017)... , Oct. 6, 2017   Provista, a ... than $100 billion in purchasing power, today announced a ... information. The Newsroom is the online home ... trends, infographics, expert bios, news releases, slideshows and events. ... to a wealth of resources at their fingertips, viewers ...
(Date:10/4/2017)... 2017  South Korean-based healthcare product Development Company I.M. ... on Kickstarter. The device will educate the user about ... better efficiency compared to the dated and pricey CPR ... efficacy of the compression for a more informed CPR ... to raise $5,000. ...
Breaking Medicine Technology: