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Vala Sciences, Inc. is a life sciences company that develops and markets pathology diagnostics, in vitro alternatives to animal cardiac and neurological assays for early drug discovery, and related technologies to academia, pharmaceutical, and biotechnology companies. The company’s multiplexed breast cancer assay includes quantitative fluorescent labels on a single slide for ER, PR, HER2/neu, and cytokeratin, and is read with an automated microscope that measures expression of all four biomarkers at the single cell level. Multiplexing speeds the pathologists’ workflow over classical reading of one biomarker/slide and by converting the current subjective scoring to an analytical test, Vala will eliminate the 15-25% error rates reported with the current standard of practice.

Vala holds a dozen issued patents and a total of 26 patents and patent applications encompassing the underlying enabling technological approaches and the key aspects of analytical biomarker testing and workflow optimization critical for this new diagnostic approach.  This digital analytical pathology diagnostic approach can be adapted to pharmaceutical research, companion diagnostics and all cancer diagnostic tests that utilize biomarkers in tissue sections – the histopathology market – a global market that will surpass $3 billion annually in 2015. Vala has raised $26.7 million since 2004 and is seeking $10 million to create a suite of related pharmaceutical biomarker assays, carry out validation studies with CLIA-approved diagnostic laboratories, introduce a laboratory-developed test (LDT), obtain FDA 510(k) approval, and ramp marketing and sales.