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Pathwork Diagnostics Looks to Collaborators To Validate TOO Test as it Awaits FDA’s OK

Pathwork Diagnostics last week said that it has partnered with Virginia Commonwealth University’s School of Medicine to evaluate the applicability of its first commercial product, an array-based multiplex tissue-of-origin test, while it awaits approval from the US Food and Drug Administration.
According to a company official, the firm will increasingly draw on partnerships and exhibitions to showcase the TOO test while the FDA reviews it for 510 (k) clearance. The company submitted the test for clearance in January and has not provided a timeline for when it expects approval.
VCU will conduct an investigational-use study to demonstrate the test’s performance in the clinical setting “and to evaluate its ability to identify the tissue of origin of human malignancies whose origin is not definitively established following routine biopsies and pathologic review of hematoxylin- and eosin-stained sections,” wrote Pathwork CEO Deborah Neff in an e-mail to BioArray News this week.
She added that the company is “in discussion” with several other institutions regarding similar studies for the TOO test and will “continue to work with major cancer centers that plan to assess the performance of our test through these investigational-use-only programs.”
Neff said that the company has received “enthusiastic support” from cancer centers “regarding the clinical need for our test and investigational results to date.”
Pathwork currently has ongoing collaborations related to the TOO test with the University of Pittsburgh Medical School, Stanford University Medical Center, and the Methodist Hospital in Houston, Tex., according to its website.
Neff wrote that the firm will also seek to raise awareness of the TOO test through exhibits and forthcoming publications.
She said that Pathwork anticipates publishing studies related to the TOO test in peer-reviewed journals in the next few months, including an article in the Journal of Molecular Diagnostics that is currently in press.
In addition, the company also plans to submit abstracts for “key oncology-based meetings,” she wrote.
TOO and the FDA
The TOO test is a 1,600-gene-signature-based diagnostic assay that runs on a custom Affymetrix GeneChip that Pathwork designed called the Pathchip. Pathwork originally signed an agreement with Affy to deploy its content on the GeneChip platform in 2005 (see BAN 11/16/2005).


In January, Neff told BioArray News that Pathwork had submitted its assay to the FDA for review. Since then, the company has offered no guidance on when it expects to be able to move ahead with full-scale commercialization plans for a cleared diagnostic (see BAN 1/16/2007).

“It is always difficult to predict timelines for the clearance process for new products going through a de novo process.”

This week, Neff was mum on when the firm expects to receive the go-ahead to market its test for clinical use. “We are in active and ongoing discussions with the FDA, working to resolve open issues regarding our product submission,” she wrote.
“It is always difficult to predict timelines for the clearance process for new products going through a de novo process. So as these discussions with the FDA reach conclusion, we will be able to provide more information regarding our timeline for clearance,” wrote Neff. She added that the firm does not have a CE Mark to sell the tests for clinical use in Europe but that this is “under consideration for the future.”
While working with the FDA, Pathwork has been building the foundation for a North America-wide marketing effort. In 2006, Pathwork’s predecessor company, Pathwork Informatics, was acquired by Predicant Biosciences for an undisclosed sum. Through the transaction, Pathwork Informatics CEO Glenda Anderson became the new company’s chief technology officer while Neff, formerly head of Predicant, became Pathwork Diagnostics’ CEO.
Shawn Becker, vice president of marketing support, and Claudia Mellen, vice president of business development, also joined Pathwork from Predicant. In May, Pathwork named David Craford its vice president of commercial operations. Craford previously served as vice president of business development at Affy.
According to Neff, Pathwork is developing additional tests on the GeneChip platform that are “operationally similar” to the TOO test, but based on “different analytics that are applied to the Pathchip microarray.”
“We are not talking publicly yet about our next applications, other than to say that our follow-on products will also be oncology-focused,” she added. In 2005, former CEO Glenda Anderson told BioArray News that Pathwork had plans for breast and prostate cancer tests in "feasibility testing" (see BAN 11/16/2005).

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