AIBiotech, a contract research organization and clinical genomic testing company, began offering next-gen sequencing-based pharmacogenomic testing using Life Technologies' Ion Torrent PGM earlier this year to physicians and patients through its CLIA-certified and NY State Department of Health-approved lab.
The firm is currently offering an NGS PGx panel available in several different versions to help guide therapy with cardiac, pain, and psychiatric drugs, the company's Founder and Executive Vice President, Thomas Reynolds, told Clinical Sequencing News this week.
Though AIBiotech works with several different sequencing technologies in its CRO activities, including the Illumina HiSeq 2500 and Roche's 454, Reynolds said that when moving forward with its PGx panel the company decided that Ion Torrent would best suit its needs.
"We use each one of these NGS platforms according to their strengths for different projects," Reynolds said. "On the clinical side, we found that for this massively multiplexed panel that the Ion Torrent did the best job." The company is among the first groups to offer clinical testing using the Ion Torrent through a CLIA lab.
AIBiotech's PGx panel for cardiac drugs covers variants in cytochrome P450 genes, including CYP2C9, CYP2c19 and CYP2D6, which are implicated in metabolism of a range of drugs, as well as a number of other targets with relevance to drug response that include Factor V and Factor II Leiden mutations, MTHFR, and ApoE genotype, according to Reynolds.
"Basically, we determine whether people are poor, intermediate, or rapid, or ultra rapid metabolisers, and provide recommendations to [ordering] doctors on [therapeutic implications]," Reynolds said.
The same panel, excluding factor V, factor II, and APOe is offered specifically to inform treatment with pain management drugs, mainly opiates, he added. And another version is targeted at psychiatric drugs.
Before launching its NGS PGx panel, AIBiotech offered PGx testing using real-time PCR and other platforms.
"It was always our goal to set this up on an NGS platform, and it became rapidly clear to us as we grew that we'd have to move toward a more high-throughput system," Reynolds said.
"Also, DNA sequence provides us with [the] depth of coverage and accuracy we were looking for … and allows us to cover a variety of mutations in all 10 genes we are looking at, and [to] multiplex at the same time, much more than with other [technologies]," he added.
Reynolds said the company does plan to expand its clinical NGS offerings, but he declined to detail what disease areas it may target in the future.
He said upcoming decisions about additional panels will be determined primarily by where the company sees the soundest science backing up clinical validity and utility, as well as what it believes it will be able to successfully seek reimbursement for and market.
"We do offer some cancer testing, so that may be an area we go into, but we are going to tread carefully with those three conditions attached to it," Reynolds explained.
The PGx panel is covered by both Medicare and private insurers, Reynolds said. Future tests AIBiotech offers would also have to merit reimbursement.
"We are not going to bring something to market that would not be paid for," he said.
One thing Reynolds said the company definitely does not plan to offer clinically is whole-genome or whole-exome sequencing.
"For the clinic, we want to develop things that we can provide for physicians, actionable information that they can use to actually do something to impact their treatment plan for patients."
Researchers at the Medical College of Wisconsin have also been developing a sequencing-based pharmacogenomics panel on the Ion Torrent PGM with plans to offer it from the college's CLIA-certified and CAP-accredited laboratory (CSN 1/11/2012).
Mount Sinai School of Medicine has also recently said it plans to develop NGS PGx panels for the Illumina HiSeq and potentially other platforms and submit them for NY State approval (CSN 1/16/2013).