Genewiz, a contract research organization specializing in sequencing and other genomic services, has announced that it is branching out into the clinical sequencing and personalized medicine space with two sequencing panels — a 25-gene general pharmacogenomic panel and a 35-gene panel for use in guiding targeted cancer therapy.
The company plans to release the two panels within the next six months, according to Guanghui Hu, Genewiz's vice president of translational genomics, who discussed the firm's new clinical push at the consumer genetics conference in Boston last month.
Hu told Clinical Sequencing News that Genewiz expects to launch the PGx test, called PGxOne, by the end of next month following a CLIA validation, and the oncology panel, OncoGxOne, early next year.
PGxOne, Hu said, is designed to run on both the Illumina MiSeq and the Ion Torrent PGM, and will initially cover 25 of what are considered the most clinically actionable PGx genes — including a number of CYP genes, VKORC1, SLCO1B1 — spanning about 26 kilobases in all, according to his conference presentation.
"We are in the final stage of CLIA validation [for PGxOne]" Hu said. "And we have a partnership with [Coriell Life Sciences] lined up to launch it immediately when that is complete, [and have] patient samples ready."
Hu declined to detail what the cost of the PGx panel will be, but said that it will be priced competitively with currently marketed single-gene pharmacogenomic tests.
"When we designed the PGx panel, we had patients and payors in mind, so the test can be used just for one gene of interest, and it is comparable in price to existing single-gene tests," Hu said. "It doesn’t have a price advantage, but it's comparable."
Hu said the company also believes that sequencing-based testing may prove itself to be more cost-effective over a patient's lifetime than repeated single-gene tests in the eyes of clinicians and payors, and that Genewiz intends to evaluate this potential cost benefit as part of a pilot study it will conduct when the company launches the test with Coriell later this year.
At the conference, Hu presented data from eight samples showing that PGxOne had nearly 100 percent accuracy calling variants as compared against a CDC reference database.
According to the presentation, the company plans to offer an additional verification step for any positive result from the PGxOne test — either Sanger sequencing or qPCR, depending on the type of variant in question — to ensure "100 percent sensitivity and specificity."
Genewiz is not the only company developing a sequencing-based PGx test. German firm CeGaT, for example, told CSN earlier this year that it is developing a pharmacogenetic panel that includes more than 340 genes (CSN 8/14/2013).
Genewiz is also far from alone in offering clinical targeted sequencing of cancer-associated genes.
Genewiz's second clinical test, OncogGxOne, will include 35 genes, according to Hu's conference presentation — 28 associated with targeted therapy and seven associated with chemotherapy response genes.
Hu said that Genewiz sees OncoGxOne as a rival to Foundation Medicine's FoundationOne test. Like Foundation Medicine, Genewiz has developed proprietary methods that allow it to detect copy number variation and gene fusions in addition to point mutations, Hu said.
Unlike the FoundationOne test, however, Hu said the OncoGxOne panel's smaller size — focused more tightly on only medically actionable genes — allows the company to run the panel on the Illumina MiSeq instead of the HiSeq and reduce costs to what he claimed is half of what Foundation Medicine charges for its test.
With broader tests, Hu said, "a lot of the information is purely for research, and [cannot] really be used in the clinic."
"We focus on a slightly smaller panel, which focuses on only genes with medically actionable information available," he said. "So we can fit it on the MiSeq instead of the HiSeq, and the user gets [a lower price, and much quicker turnaround time.]"
Additionally, OncoGxOne includes some genes associated with response to chemotherapy, which Hu said many cancer panels do not.
"We were thinking about the patient when we designed the panel. Walking into a doctor's office they are not just thinking about targeted therapy. Chemo may be part of first line treatment … so we integrated that information into the [test] as well," Hu said.
Genewiz's new panels join a set of smaller cancer-specific panels as well as a broader PGx panel the company already offers for research use only.
According to Hu, after the company launches the PGx Panel this year, it expects to move forward with CLIA validation of OncoGxOne and release it, hopefully, by March 2014.