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Helicos Targets 2011 Launch for Molecular Test for Hereditary Breast, Ovarian Cancer


This article was originally published June 25.

About a month after Helicos BioSciences laid off half its workforce to refocus its business on diagnostics, the company said last week that it is in the early stages of developing several molecular diagnostics tests.

Helicos said it will launch a test in the second quarter of 2011 that will identify gene mutations associated with a woman's risk of developing hereditary breast or ovarian cancer. It also plans to develop additional MDx tests such as non-invasive prenatal diagnostic tests.

The company did not disclose which genes it plans to evaluate for the hereditary breast and ovarian cancer test.

"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' president and CEO Ron Lowy said in a statement.

Under its new, diagnostics-focused plan, Helicos said it has begun developing its own genetic testing laboratory for which it will seek CLIA certification.

In addition, the company recently hired Robert Wassman, formerly vice president and national medical director of Genzyme Genetics, as its chief medical officer because of his "experience in the clinical translation of innovative genetic testing technologies."

Wassman, who will facilitate the company's transition to focus on clinical applications, founded the company Good Start Genetics, which used sequencing to assess carrier status for rare genetic disorders.

In May, when Helicos decided to restructure, it said that under its current business model there was doubt about its ability to continue operations because it had not been successful at raising funds. The company said that as of mid-May it had received no new orders for its HeliScope machines in 2010. By the end of 2009, it had received orders for 10 instruments and recognized revenue on two of the orders (IS 5/18/2010).

As of March 31, Helicos had $11.3 million in cash and cash equivalents.

Helicos first disclosed late last year that it was considering repositioning itself to focus on diagnostics (IS 12/15/2009). The company has said that its single-molecule sequencing platform is well-suited for molecular diagnostic applications due to its quantitative accuracy, small sample input requirements, relatively simple sample-prep methods and high throughput, and a lack of bias from sample amplification.

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