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Despite Recent Acquisition, Pathwork Diagnostics Still Intends to Submit Test to FDA This Year

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Though Predicant Biosciences' acquired of Pathwork Informatics last week, the combined new firm, called Pathwork Diagnostics, will stay true Pathwork's original plan to launch a test for the origin of secondary and unspecified malignant cancers by year end, according to a company official.

Last fall Pathwork Informatics then-CEO Glenda Anderson told BioArray News that the company this year planned to submit for US regulatory approval a PathChip for identifying the tissue of origin for metastatic cancers (see BAN 11/16/2005).

This week the company affirmed its plans to deliver the test within that timeframe and said that the acquisition would not hamper its plans to do so.

"The validation of Pathwork's test is underway; once complete, the company plans to submit it for [US Food and Drug Administration] clearance. The acquisition should not affect timing of this process," Deborah Neff, the president and CEO of the combined firm, told BioArray News.

According to a statement from Pathwork, the first, yet-to-be-named test will be applicable for diagnosing cancer of unknown primary (CUP), which occurs when metastatic cancer is found but its origin cannot be determined.

The test runs on the Affymetrix platform and the company joined Affy's "Powered by Affymetrix" diagnostics program • which enables diagnostic shops to use the array firm's technology • in October 2005. Affymetrix will also manufacture Pathwork's chips through an OEM deal, according to the company.


"The validation of Pathwork's test is underway; once complete, the company plans to submit it for [US Food and Drug Administration] clearance. The acquisition should not affect timing of this process."

Last November, Anderson said that Pathwork had pursued the CUP application for "strategic" reasons. "It requires a large number of genes to do well, so it really lends itself to a microarray platform," she said, adding that CUP is "a difficult problem." She said that nearly 30,000 patients a year are diagnosed with CUP and face a "costly, frustrating, and time-consuming series" of diagnostic procedures that are "successful just 25 percent of the time."

The decision to pursue a chip that will be used in CUP diagnostic applications may eventually put Pathwork in direct competition with Agendia, a Dutch diagnostics firm affiliated with the Netherlands Cancer Institute that already sells a microarray-based test called CupPrint. The test uses a gene-expression database of 32 different tissue types and 78 tumor types to make a diagnosis in CUP patients. Agendia has been offering it as a service through its Amsterdam-based labs since 2005 (see BAN 2/9/2005).

Agendia also sells a breast cancer recurrence prognostic called MammaPrint in Europe, and the firm recently closed a private financing round to back its efforts to submit MammaPrint for FDA clearance in the US (see BAN 6/6/2006).

Similarly, Pathwork has plans for breast and prostate cancer tests, albeit in "feasibility testing," Anderson said at the time. Pathwork expects that these chips will also be available through its agreements with Affy.

By looking to tap the market for array-based prostate cancer tests, Pathwork could also compete against other diagnostics shops using the Affy platform. For example, Affy partner Epigenomics, a German molecular diagnostics firm, announced its intentions this month to deliver a prostate recurrence test by the second half of 2007 (see BAN 7/5/2006).

New Team

Despite Pathwork Diagnostics' relatively small size compared to other Affy partners planning diagnostics • including bíoMerieux, Roche, and J&J's Veridex business • it is possible that the company could beat all the others to be the next firm to debut an FDA-cleared test on the GeneChip platform. Of all of Affy's partners, only Roche has announced a tentative date • 2009 • for its next array-based diagnostic (see BAN 3/7/2006).

Pathwork Diagnostics is backed with $11 million from Prospect Venture Partners, Advent Venture Partners, Novus Ventures, Venrock Associates, and Versant Ventures and has roots in both genomics and proteomics through Pathwork Informatics, according to Neff.

"Predicant was a clinical proteomics company focused on oncology diagnostics through analysis of protein patterns in the blood," the new CEO, who also served as CEO of Predicant, explained.

"This provides a great fit for the new company, enabling the management team from Predicant to leverage this recent oncology diagnostics experience, along with a very strong network of clinical advisors," she said.

While Neff will lead the new firm, Anderson will serve Pathwork as chief technology officer. But it is some of the firm's other new officials that give Pathwork its clinical labs and microarray pedigree.

Among Pathwork's incoming team are its new chairman, Richard Bastiani, who is also chairman of Response Biomedical, a clinical and environmental diagnostics company; and board members Richard Klausner, a former global health executive director of the Bill & Melinda Gates Foundation's Global Health program and former director of the National Cancer Institute; and Kenneth Nussbacher, who previously served as executive vice president and chief financial officer at Affymetrix.

Coming from Pathwork Informatics is the firm's vice president of sales and marketing, Ted Riegl, who previously served at Applied Biosystems, Dade Behring and Baxter-Dade. Neff added that some of its other employees come from Behring Diagnostics and Abbott Laboratories. Neff said that the company's management "has significant experience and expertise in molecular diagnostics • and in the life science arena generally."

Although some of the major managerial positions have shifted, Neff added that the company "does not anticipate any major personnel changes associated with the acquisition." She said that Pathwork "is currently operating out of Pathwork Informatics' location in San Jose, [Calif.]" Predicant is based in South San Francisco. With new funding, Pathwork Diagnostics also "plans to add additional capabilities in the future," Neff said.

Pathwork's backers will also have their say in the firm's agenda. James Tananbaum, managing director at Prospect Venture Partners, Shahzad Malik, a general partner at Advent Venture Partners, and Greg Lahann, managing director at Novus Ventures, will all sit on Pathwork's board, according to Neff.

Affy's Dx Strategy

Pathwork Diagnostics' decision to stick to its timeline for introducing tests, along with the recently announced Epigenomics deal, could be seen as good news for Affymetrix's "Powered by Affymetrix" program.

Affy routinely courts investors at conferences by singling out the program, after expression analysis and genotyping, as one of the key pillars of its business strategy. However, to date only one diagnostic on the Affymetrix platform has received FDA clearance • Roche's AmpliChip, which was cleared for clinical use in January 2005 (see BAN 1/5/2005).

Recently, Greg Schiffman, the firm's chief financial officer, told investors at Nasdaq's 17th Annual Investor Program, held in London last month, that Affy sees itself as a "diagnostics player" and to be "a standard in the industry."

Schiffman said that there are currently "14 diagnostics underway" in the "Powered by Affymetrix" program, and that the company sees diagnostics as a "strong growth opportunity as [it] looks out a few years from now" when many of the tests are expected to hit the market.

• Justin Petrone ([email protected])

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