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Helicos Eyes Dx Test Launch Next Year

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Helicos BioSciences today said that it has launched its diagnostics business and intends to commercialize its first sequencing-based test to the market next year.

The Cambridge, Mass.-based single-molecule sequencing technology firm last month said that it was starting the process of repositioning its strategy with a focus on the molecular diagnostics field. Part of that repositioning includes laying off half of its workforce, or 40 positions.

Helicos today said that it is in the early stages of validating molecular diagnostic tests that would use the firm's HeliScope single-molecule sequencer. Though the firm said that it believes the HeliScope will have utility across a broad range of MDx tests, it is initially developing a test intended to identify gene mutations indicating a woman's increased risk of developing hereditary breast or ovarian cancer. Helicos did not disclose which markers the test will target, but it said it intends to launch the test in the second quarter of 2011.

"Over the past months, we have considered a number of alternatives to our long-term strategic focus and consulted with industry experts, many of whom shared our confidence in the HeliScope Sequencer," Helicos President and CEO Ron Lowy said in a statement. "Ultimately, we decided developing tests for the nascent and expanding diagnostics sequencing market presented the best opportunity to deploy technology that will potentially drive rapid near term revenue growth by providing attractively priced MDx tests."

Helicos said that it is developing additional tests for "well-established" markets. It intends to evaluate the development of sequencing-based tests for detection and quantification of foreign DNA/RNA circulating in the bloodstream, such as a non-invasive prenatal diagnostic test.

Many of the firms that sell the latest generation of sequencing technologies are eying molecular diagnostics applications, due to that market's rapid growth rate of around 15 to 20 percent annually. For example, in April, sequencing firm Knome teamed up with established diagnostics firm BioMérieux to develop and market sequencing-based tests.

And last week, Gen-Probe announced that it was making a $50 million investment in Pacific Biosciences and that the firms will collaborate on developing new integrated diagnostic systems based on PacBio's Single Molecule Real Time platform.

In Friday morning trade on the Nasdaq, shares of Helicos were up 16 percent at $.50.