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Pathwork Submits Tissue-of-Unknown Primary Test to FDA; Expands Sales, Support Teams

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After taking a year to focus on building its commercial organization and to tweak its flagship array-based oncology diagnostic for US Food and Drug Administration clearance, Pathwork Diagnostics has submitted its test to the FDA and is preparing for a full commercial launch of the product in coming months, according to a company official.
 
CEO Deborah Neff told BioArray News in an interview this week that the company has submitted for FDA approval a diagnostic test for tumors of unknown origin, and that it is busy building its infrastructure to support a launch upon receiving a positive response from the regulatory body.
 
Pathwork’s test is manufactured on Affymetrix’s GeneChip platform, and if cleared it would be the first diagnostic on Affy’s platform to reach the clinical market since Roche’s CYP450 AmpliChip drug metabolism test received 510 (k) clearance two years ago (see BAN 1/5/2005).
 
“The tissue of origin test is now under review at the FDA. While we are waiting for their final response, we are preparing for commercialization,” Neff said.
 
“That means that we are building our sales and application support team,” she added. “We are also bringing in medical advisors to help work with pathologists and oncologists as we get through the adoption process. We are preparing internally so that we … have all the process methods underway so that we can sell the product to the customer,” Neff said.
 
Neff said that the company, now around 20 people, has nearly doubled since last June, and will most likely grow to up to 32 employees by the end of this year. The company is currently seeking to round out its team with more financial support personnel as well as a chief medical officer, she said.
 
In November 2005, Pathwork’s former CEO Glenda Anderson told BioArray News that the company would submit for US regulatory approval a PathChip for identifying the tissue of origin for metastatic cancers by the end of 2006 (see BAN 11/16/2005).
 
Last July, Predicant Biosciences acquired the firm — then called Pathwork Informatics, for an undisclosed sum — and the companies combined management teams, with Predicant’s CEO Neff taking the same position at Pathwork Diagnostics and Anderson moving into the role of chief scientific officer (see BAN 7/11/2006). Pathwork moved from its office in downtown San Jose, Calif., into a new laboratory space in nearby Sunnyvale in November.
 
“We did the merger and acquisition at the beginning of the summer, and then took the summer to take a real hard look at our study and tried to fine-tune everything, and then we completed our analytical studies and clinical validation studies in the early fall,” Neff explained, noting that by filing the test with the FDA in late December, the firm met its internal deadline of submitting for 510 (k) clearance by the end of 2006.
 
Pathwork’s diagnostic, called the Tissue-of-Unknown Origin test, measures the gene expression of select genes to quantify the molecular similarity of a biopsy specimen across 15 different tissues and about 60 morphologies of known origin.
 
The test is run on an array manufactured by Affymetrix, but Pathwork developed the proprietary algorithm and analysis tools that make it work. Neff said that the OEM deal with Affy will enable Pathwork to “standardize data across multiple labs and lab processes” while remaining a comparatively cost-efficient business because it doesn’t need to sell an instrument.
 
Pathwork’s business model calls for clinical labs to run the test using an Affy scanner. Clinicians then send a data file to Pathwork for analysis and the company sends a summary report back to the lab. Pathwork expects that clinicians will use the information to identify the tumor origin in cancer patients who lack positive diagnosis.
 
Pathwork may have a niche test at the moment, but it may eventually compete with Agendia, a Dutch diagnostics firm affiliated with the Netherlands Cancer Institute that already sells a microarray-based test tumor-of-unknown origin test called CupPrint. The test uses a gene-expression database of 32 different tissue types and 78 tumor types and Agendia has been offering it as a service through its Amsterdam-based labs since 2005.
 

“We do expect that reimbursement will be case-by-case to start with, and we’ll be providing a fair amount of support to the various labs as they go through their reimbursement processes.”

Agendia CEO Bernard Sixt told BioArray News in an interview last July that Agendia is currently focused on introducing its MammaPrint array-based test for breast cancer recurrence in the US, and that products like CupPrint may follow a similar route.
 
“For the US we are looking momentarily only into the correct regulatory path for MammaPrint,” Sixt said at the time. “This is a learning process and we are confident that other products may benefit later from our experience,” he added.
 
As Pathwork prepares to market its test, Neff said that the company is keeping a wary eye on reimbursement issues. “We do expect that reimbursement will be case-by-case to start with, and we’ll be providing a fair amount of support to the various labs as they go through their reimbursement processes,” she said.
 
“We are already meeting with some of the large payers regionally. We will work hard to get the clinical evidence in place and the advocates in place so that we can get broader coverage over the next year or two,” Neff added.
 
Neff said that the company will also look to develop additional content for its tissue-of-unknown primary test, including more tissue samples and additional information to help guide treatment decisions.
 
Neff declined to name additional products in Pathwork’s pipeline, although she affirmed the company’s focus in oncology. In 2005, Anderson told BioArray News that Pathwork had plans for breast and prostate cancer tests in "feasibility testing."
 
Anderson said at the time that Pathwork expects that these chips will also be available through its agreements with Affy (see BAN 11/16/2005).

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