Life Technologies this week broadly outlined its strategy for growing its molecular diagnostics business, which will include its next-generation sequencing platforms.
The company's new president of medical sciences, Ronnie Andrews, has been developing a "comprehensive strategy" to expand the firm's molecular diagnostics presence and to capitalize on its existing platforms and tools in the clinic, according to Greg Lucier, Life Tech's CEO and chairman.
Life Tech already has more than 7,500 instruments in clinical settings "that enable hospitals and labs to develop and use assays," including capillary electrophoresis, qPCR, SOLiD, and Ion Torrent PGM instruments, he said. The company is currently focusing on these existing clinical placements "and determining how we can extract value from this installed base."
Lucier, who made his remarks during a conference call to discuss Life Tech's first-quarter earnings, said that the company's technologies position it well to support assay development and "information synthesis" in five disease areas: oncology, inherited disease, transplant diagnostics, infectious diseases, and neurological disorders.
He said the company has a strategy and timeline for entering each of these markets and promised future updates "as the strategy unfolds."
Specifically, he said, Life Tech is working with unnamed pharmaceutical companies to develop companion diagnostic panels for new treatments. "With over 500 new targeted therapeutics in the oncology space alone, we know there are complex decisions to be made and that molecular diagnostics solutions, covering both the proteome and the genome, will need to be involved."
Life Tech also plans to broaden its clinical offerings by adding "newly introduced technologies," as well as fluorescent microscopy and flow cytometry, so it will be "more than a single-discipline product supplier to the clinical market," Lucier said.
In addition, the company is working on "new innovative informatics solutions" in order to simplify "the vast amount of information" resulting from diagnostics for complex diseases, he said.
Lucier stressed that Life Tech's molecular diagnostics strategy will not only involve genomic technologies. "I think one of the differentiators for us is that we will not just be on the genomics side of things, we will be a more broader-based solutions provider that will include genomic, proteomic, and other aspects of our technology," he said.
As previously stated, the company plans to seek 510(k) approval for the Ion Torrent PGM from the US Food and Drug Administration. In preparation for that, it recently started to manufacture the system at its Singapore factory, which already produces its 510(k)-approved qPCR instruments, said chief operating officer Mark Stevenson. The Singapore facility produces certain products under FDA Quality Systems Regulations at 21 CFR Part 820, according to a recent company statement.
Lucier also said that the recently introduced AmpliSeq technology, which allows PGM users to amplify and analyze panels of up to hundreds of genes in a day, will "transform disease research."
He claimed that the AmpliSeq custom panels the company launched in March are "one of the most important breakthroughs since qPCR, unlocking archive research samples containing low amounts of DNA."
The company has also hired a "focused selling force around the clinical opportunities" of the PGM, Lucier said, but provided no further details.