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Sequenta Looks to 2013 for Launch of Sequencing-based Cancer Test

By Tony Fong

NEW YORK (GenomeWeb News) – Having demonstrated the utility of its technology, molecular diagnostics firm Sequenta will focus on clinical validation of its technology in 2012 with an expected launch of its first product next year.

During the past year, the South San Francisco, Calif.-based firm has concentrated on proof-of-concept work directed at its technology, which is based on immune repertoire sequencing. The firm is now in the process of seeking CLIA certification for its laboratory and is eyeing the launch of a test for monitoring disease in lymphoid cancers, Sequenta Co-founder and CEO Tom Willis told GenomeWeb Daily News.

Sequenta, founded in 2008, published five studies in the past year showing the utility of its technology to measure "very small" amounts of cancer in circulation during and after treatment in childhood and adult cases of acute lymphoblastic leukemia, chronic lymphoblastic leukemia, and mantle cell leukemia.

In the coming year, it will collaborate with researchers to clinically validate its technology and in 2013 expects to offer tests, Willis said on the sidelines of the 30th Annual JP Morgan Healthcare Conference in San Francisco earlier this month.

Sequenta raised $13 million in a Series B round a year ago, and the company has enough in its coffers to last through its initial product launch, he added.

As part of its commercialization ramp-up, Sequenta will work on a reimbursement strategy "so that we hit the ground running next year," said Willis. The firm also brought Laura Parmer-Lohan on board in October as vice president of marketing to help with those plans. Prior to Sequenta, she was executive director of marketing for Genoptix, which Novartis acquired a year ago.

Sequenta's technology, which profiles recombined DNA sequences in T- and B-cell cells, was developed in-house by Willis and Co-founder Malek Faham. After a blood sample is drawn, individual molecules of nucleic acid derived from the T- and B-cells are spatially isolated and amplified by PCR, and then sequenced. The DNA sequences are then reconstructed via bioinformatic methods.

Other firms, such as iRepertoire also offer immune repertoire sequencing and analysis services, but unlike them, Sequenta is targeting the clinical market, not the research market. Another firm, Adaptive Biotechnologies, formerly called Adaptive TCR, also is moving into the clinical arena.

Sequenta's first assays will target lymphoid cancers, but because the immune system is implicated in a wide range of diseases, the company is developing assays for other diseases and assays for use as companion diagnostics for autoimmune disease therapies.

"Measuring immune system response to different things is becoming an increasingly important part of healthcare," Willis said, though he declined to provide details on the progress of that development.

In the short-term, Sequenta plans on running its assays in its own laboratory, but further out, it hopes to make its tests available through other CLIA labs.

The lymphoid cancer test is also intended for use along its entire spectrum, from diagnosis to monitoring of the disease. "Our goal is to make this a routine viral load assay … for lymphoid cancer that is cost-effective and non-invasive, so that clinicians can track their patients through their episode of care into remission and subsequently monitor them for relapse," Willis said.

The company has been using Illumina's HiSeq platform to develop its tests, but Willis declined to say whether it will continue to do so going forward. He said Sequenta is continually monitoring the development of sequencing platforms and speaking with vendors.

Life Technologies business Ion Torrent recently unveiled its Ion Proton benchtop sequencer that the company said is capable of sequencing the human genome in one day for $1,000. On the same day, Illumina announced a new HiSeq instrument it said can also sequence a human genome in one day.

As sequencers improve in throughput and costs drop, that will only hasten Sequenta's own development work, Willis said. The company's technology and IP estate around it are platform-independent, so "there also will be more than one version of the product that we're going to launch … even if we launch an initial product on one platform, that doesn't stop us from working on another platform in the future," he said.