Pathwork Diagnostics

Press Release.

REDWOOD CITY, California – Pathwork Diagnostics Inc., a molecular diagnostics company focused on oncology, today announced that it has entered into a research collaboration with Novartis.

The parties intend to discover clinically meaningful biomarker signatures that can serve as the basis for diagnostics across a range of cancer types. Under the terms of the agreement, both parties have rights to develop and commercialize the diagnostic products.
Financial terms were not disclosed.

“There is no question that the future of cancer treatment will require and depend on molecular diagnostics,”

said Richard Klausner, M.D., former director of the National Cancer Institute and member of Pathwork Diagnostics Board of Directors.

“The collaboration between Pathwork and Novartis has the potential to yield diagnostic products that improve the quality of cancer care worldwide.”

About Pathwork Diagnostics
Pathwork Diagnostics Inc. develops and commercializes high-value molecular diagnostics for oncology and is a privately held company based in Redwood City, Calif. The company’s Tissue of Origin Test is the only FDA-cleared molecular test that assists in the determination of the tissue of origin. The test uses microarray-based RNA profiling to compare the patient’s specimen to a database of known tumor types. The accurate and reproducible results are evaluated by the physician in the context of the patients’ clinical history and complementary diagnostics, such as immunohistochemistry.

Press Release.

Pathwork Diagnostics, Inc., a molecular diagnostics company focused on oncology, announced that the U.S. Food and Drug Supervision (FDA) has cleared its Pathwork(R) Tissue of Genesis Test concerning purchase in determining the origin of debatable tumors.

The assess analyzes a tumor’s gene wording diagram to help pinpoint the beginning of insensitive-to-relate to tumors and is the first test of its kind to walk off FDA clearance. Up to an estimated 200,000 newly diagnosed cancer patients annually in the U.S. may have a tumor for which the site of origin is uncertain after the initial diagnostic workup. The FDA’s clearance underscores the growing capacity that patients’ genomic information can drag one’s feet use in helping physicians make preferably decisions.

“Knowing the primary tumor plat with greater certainty enables more appropriate cancer treatment. The growing style in cancer nurse is the fritter away of therapies that target specific tissues and their genomic components, rather than relying on a one-size-fits-all treatment approach,”

said Deborah J. Neff, President and Chief Executive Officer of Pathwork Diagnostics.

“We believe the Pathwork Tissue of Creation Check up on will help purvey more certainty in tumor diagnosis, which will enable more patients to realize the benefits of this experimental times in genomics-based diagnostics.”

The FDA-cleared Pathwork Tissue of Commencement Test will be present as an in vitro diagnostic (IVD) kit, message that clinical laboratories can run the evaluate themselves. The test is currently within reach as a service through Pathwork’s CLIA-certified laboratory.

The Pathwork Tissue of Origin Prove uses a microarray to measure the expression pattern, comprising more than 1,500 genes, in the indecisive tumor and compares it to expression patterns of a panel of 15 known tumor types, representing 60 morphologies blanket, to help shape the tumor’s origin. In the in vitro diagnostics clinical validation study submitted to the FDA, the test demonstrated 89 percent auspicious agreement (akin to sensitivity) with close by diagnoses and 99 percent cool agreement (akin to specificity). The cram consisted of 545 metastatic, poorly differentiated and undifferentiated tumors that had been identified as sole of the 15 tumor types on the panel using existing methods. The assay demonstrated an as a rule 94 percent overall concordance across four laboratories in a cross-laboratory comparison scrutiny of 60 metastatic, inadequately differentiated and undifferentiated tissue specimens.

“Hard-to-identify tumors are a significant clinical problem,”

said Dr. James Abbruzzese, Professor of Medicine at M.D. Anderson Cancer Center.

“They are time-consuming and frustrating in requital for both physicians and patients. Accurately identifying a tumor’s origin — and ergo knowing what thoughtful of cancer the tenacious has — is necessary seeking dawn standard-of-care, cancer-proper to treatment per the National Comprehensive Cancer Network Clinical Practice Guidelines. Knowing the tumor’s origin can also enable patients to get into — and benefit from — appropriate clinical trials.”

Targeted cancer therapies can be clobber even with metastatic tumors and are typically tumor-specific (e.g., Herceptin® for breast cancer), requiring identification of the primary tumor purlieus or tissue of origination. Targeting therapy to clear-cut tumor types can allow patients to avoid the toxicity of broader chemotherapy.

“Traditional tools inured to to identify tumors of inconstant origin include imaging studies, such as CT scans and MRIs, as well as a thorough pathological appraisal with immunohistochemistry and other techniques,”

said Federico Monzon, M.D., Director of Molecular Diagnostics of The Methodist Hospital in Houston.

“However, seeking difficult cases the use of these complex iterative techniques can often chronicle b debase weeks, and in some cases they smooth do not definitively identify the tissue of origin. A gene expression probe of a piece with the Pathwork Tissue of Derivation Check provides unrivalled facts and, based on this text, it is reasoned to expect that it will promote the diagnosis of uncertain primary tumors.”

Pathwork Diagnostics

Pathwork Diagnostics, Inc., based in Sunnyvale, California, develops and commercializes high-value molecular diagnostics with a view oncology. The firm delivers FDA-cleared, microarray- ased tests to clinical laboratories and also provides diagnostic tests through its CLIA-certified laboratory. The company’s initial tests utilize Pathwork Diagnostics’ proprietary analytics and a companion Pathchip(R) microarray, which runs on the proven Affymetrix GeneChip(R) System. The company’s start test — the Pathwork Tissue of Fountain-head Study — is now FDA-cleared as an in vitro diagnostic kit. A functionally equivalent understanding of the check up on is also present through Pathwork(R) Diagnostics Laboratory. The test aids in determining a tumor’s origin so that model-of-care, cancer-specific treatment can set out.

www.pathworkdx.com

Press Release.

Second Round of Funding Supports Commercialization of Recently FDA-cleared Pathwork® Tissue of Origin Test

SUNNYVALE, Calif. — Pathwork Diagnostics, a molecular diagnostics company focused on oncology, announced the closing today of a $20 million financing led by Abingworth. The announcement came on the heels of FDA’s clearance for the Pathwork® Tissue of Origin Test for diagnosis of tumors of uncertain origin, including poorly differentiated, undifferentiated and metastatic tumors.

”With this $20 million round of financing completed and the recent FDA clearance, the company is well positioned to fund important commercialization programs, including offering the Pathwork Tissue of Origin Test through an additional distribution channel, and building our pipeline,”

said Deborah J. Neff, President and Chief Executive Officer of Pathwork Diagnostics.

In addition to offering the Pathwork Tissue of Origin Test as a service through the CLIA-certified Pathwork Diagnostics Laboratory, FDA clearance of the in vitro diagnostic (IVD) kit version of the test will give Pathwork’s customers the opportunity to purchase an IVD kit and run the test in their own labs.

“Our channels to market are expanding and we are building our customer support team to provide outstanding service to our customers,” said Neff. “In addition, we are investigating new applications of our technology that will enable us to offer new, breakthrough diagnostic capabilities to the oncology community.”

Pathwork’s lead investor, Abingworth, based in London and with local offices in Menlo Park, Calif., specializes in the life sciences and healthcare industries.

“We are delighted to become an investor in this unique company,” said Ken Haas, Venture Partner with Abingworth. “Molecular diagnostics is already making a significant difference in the care of cancer patients and Pathwork, with its combination of a novel and proprietary approach, a validated test available through two commercial channels and a broadly applicable platform, is poised to be a leader in this field.”

Abingworth joins the existing investors participating in this round, including Prospect Venture Partners, Advent Venture Partners, Novus Ventures, Venrock and Versant Ventures.

“Completing this successful financing in the current economy, with well-respected investment firms is a strong vote of confidence in our technology and commercialization strategy”

said Neff.

About Pathwork Diagnostics
Pathwork Diagnostics, Inc., based in Sunnyvale, Calif., develops and commercializes high-value molecular diagnostics for oncology. The company delivers FDA-cleared, microarray-based tests to clinical laboratories and also provides diagnostic tests through its CLIA-certified laboratory. The company’s initial tests utilize Pathwork Diagnostics’ proprietary analytics and a companion Pathchip® microarray, which runs on the proven Affymetrix GeneChip® System. The company’s first test – the Pathwork Tissue of Origin Test – is now FDA-cleared as an in vitro diagnostic kit. A functionally equivalent version of the test is also available through Pathwork® Diagnostics Laboratory. The test aids in determining a tumor’s origin so that standard-of-care, cancer-specific treatment can begin. For more information, please call toll-free 1.877.808.0006 or visit www.pathworkdx.com.

© 2008 Pathwork Diagnostics, Inc. All rights reserved. Pathwork, Pathchip, Pathwork Diagnostics, and the Pathwork Diagnostics logo are trademarks or registered trademarks of Pathwork Diagnostics, Inc. Other names may be the trademarks of their respective owners.