Helicos BioSciences Corporation (NASDAQ: HLCS) announced today that it is in the early stages of validating molecular diagnostic (MDx) tests that utilize its HeliScope® Single Molecule Sequencer. The HeliScope Sequencer’s ability to sequence single molecules of natural, unamplified DNA or RNA simplifies the diagnostic testing workflow obviating the need for the amplification steps utilized by most genetic analysis methods. This ability to eliminate amplification steps has several advantages including the potential for Helicos to sell its MDx tests for substantially less than the price of comparable existing diagnostic tests.
“Our plan to develop and market our own MDx tests is driven by our confidence in the unique capabilities of the HeliScope Sequencer,” stated Ron Lowy, President and Chief Executive Officer. “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. 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 believes that the HeliScope Sequencer will have utility across a broad array of MDx tests. Initially, Helicos is developing a MDx test that will identify gene mutations indicative of a woman’s increased risk of developing hereditary breast or ovarian cancer. This test is currently scheduled to launch during the second quarter of 2011.
Helicos is also developing additional MDx tests in well-established markets. Helicos intends over the longer term to use its core technology’s quantitative capabilities to explore developing MDx tests based upon the detection and quantification of foreign DNA/RNA circulating in the bloodstream, such as a non-invasive prenatal diagnostic test.
In furtherance of its new strategic plan, Helicos has begun development of its own genetic testing laboratory for which it expects to seek certification under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). In connection with this, Helicos recently hired Dr. Robert Wassman as Chief Medical Officer (CMO). Dr. Wassman has over 25 years of experience in the clinical translation of innovative genetic testing technologies, and has held a variety of professional and senior management positions. Most recently, he was a Founder and CMO of Good Start Genetics, a company focused on the application of “Next Generation” DNA sequencing to assess individual carrier status for rare genetic disorders. Previously, he was President of Celula, Inc., which developed instruments for the isolation and analysis of rare, highly informative cells for personalized diagnostics. Prior to these start-up ventures, he was the Vice President and National Medical Director of Genzyme Genetics, where he held operational responsibility for all clinical services and genetic counseling, and also led business development and new product implementation for their reproductive franchise.