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The Paris-based firms earlier this year announced a partnership to develop monoclonal antibody microarrays that combine BSI's antibodies with MBC's microarray platform.

Although Arrayit had previously said it would pursue 510(k) clearance for OvaDx, Schena told PGx Reporter this week that the company chose the PMA path in order to prove that the technology platform for OvaDx could "pass muster in a rigorous clinical trial," and differentiate the test in the marketplace.

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Arrayit's 3 Series Microarray Substrate Slides, SuperMask Substrates, VIP Genotyping Packages, and Whole-Cell Microarray Printing Pins

While the pre-market approval route is more stringent than the 510(k) pathway and is for devices with the highest risk to patients, the company said it would be the most appropriate strategy for its ovarian cancer test.

Results from the 94-subject study suggest that the test could be useful in screening high-risk patients for ovarian cancer and possibly even as a screening diagnostic for the general population, a Georgia Tech researcher said.

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Duane Steele, Gregory Freitag, Wolfgang Renz

The trial will study samples from 1,150 patients in Australia and the UK to explore the utility of adding two protein biomarkers to the test to improve its sensitivity and specificity, Nick Gatsios, HealthLinx managing director, told ProteoMonitor.

The Sunnyvale, Calif.-based array company said its growth has been "frustrated" by a lack of capital and inability to meet orders, and that it expects to close one or more rounds of financing during the second quarter of this year.

The hiring of a diagnostic oncology CRO seems to signal that Arrayit is readying its OvaDx test for a clinical trial in preparation of filing for FDA approval.

Arrayit is hoping to submit OvaDx, an array-based pre-symptomatic ovarian cancer test that includes 100 proteomic biomarkers, to the FDA later this year.


The former commissioner of the FDA has returned to the venture capital firm New Enterprise Associates as a special partner on the healthcare investment team.

Astronauts have edited yeast genes on the International Space Station in an experiment designed to show how cells repair themselves in space.

Emory University has found that two of its researchers failed to divulge they had received funds from China, according to the Atlanta Journal-Constitution.

In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.