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Pathwork First to Net FDA OK for CUP Dx

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By being the first to launch an FDA- and CLIA-approved test designed to help physicians determine cancer type in a tumor, Pathwork Diagnostics may have gained a significant advantage over competitors.

This summer, Pathwork received 510(k) clearance from the FDA for its Tissue of Origin test.

The test, which uses Pathwork's PathChip microarray and runs on Affymetrix's GeneChip platform, "is the first custom Affymetrix gene expression array to be cleared for diagnostic use," the FDA noted in a statement.

Pathwork is not the only company with a diagnostic test for cancer of unknown primary origin. Currently, AviaraDx markets a CUP assay in the US, called Aviara CancerTYPE ID, which Agendia markets in Europe as CUP-Print. AviaraDx plans to submit its test for FDA clearance in the next 12 to 18 months.

Meanwhile, Rosetta Genomics and Exiqon are both developing a diagnostic for the indication.

However, Pathwork's product is the only test that is FDA-cleared for CUP, and its regulatory approval also marks an achievement for the agency. The Tissue of Origin test is only the second in vitro diagnostic multivariate index assay to receive the FDA's approval.

The FDA has said that it intends to regulate so-called IVDMIAs, a subset of laboratory-developed tests that combine multiple variables into a single, predictive test, and has issued two draft guidances in this regard. The first IVDMIA to receive a nod from the FDA was Agendia's MammaPrint assay for breast cancer recurrence. 

According to the National Cancer Institute, between 2 percent and 4 percent of US cancer patients have a cancer for which the primary site is never identified. David Craford, Pathwork's VP of commercial operations, says that "the cost to identify a primary tumor can be significant," since traditional treatment approaches involve running multiple diagnostic technologies in parallel.

Turna Ray

PGx & Molecular Dx Notes

Northern Ireland-based Almac Diagnostics kicked off an international, multi-center collaborative lung cancer study aimed at finding a prognostic gene expression signature for patients with early non-small cell lung cancer. The study will be led by Dean Fennell at Queen's University Belfast.

HX Diagnostics expanded a license and development agreement with Nanogen, under which the companies will develop rapid, point-of-care diagnostics for respiratory infectious diseases. The firms are developing a fluid test to detect multiple strains and subtypes of influenza, including avian influenza, in one test.

Sequenom certified its first Center of Excellence for genotyping technology — the McGill University and Genome Quebec Innovation Centre.

Datapoint

$27.8 Million
Genomic Health reported that second-quarter revenue was $27.8 million, up 89.1 percent from its revenue in the same quarter last year.

Funded Grants

$658,595/FY 2008
Proteome signatures and target validation in lymphomas
Grantee: Daniel Jay, Tufts University
Began: May 1, 2004; Ends: Jul. 31, 2010

Jay and his colleagues will use the funds to improve the use of proteomics as a pharmacogenomic tool by developing surface proteome signatures and performing functional proteomic target validation analysis directly on primary tumor tissue. Part of the proteome signature will help differentiate how someone is responding to a therapeutic.

$572,928/FY 2008
Corticosteroid Pharmacokinetics and Pharmacodynamics
Grantee: William Jusko, SUNY Buffalo
Began: Jul. 1, 1977; Ends: Jun. 30, 2010

Currently, this NIGMS grant is funding Jusko and his colleagues to study pharmacogenomics as well as pharmacokinetics and pharmacodynamics in rat. The team will study genes from liver, muscle, and kidney tissue using microarrays, and hopes to assess the expression of biomarkers for diabetes.

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