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Genewiz Planning to Release Next-Gen Sequencing PGx Panel Next Month; Cancer Panel to Follow

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Genewiz, a contract research organization specializing in sequencing and other genomic services, is branching out into the clinical sequencing and personalized medicine space and is planning to introduce two targeted sequencing-based tests in the coming months.

The first test is a pharmacogenomic panel, covering about 25 of the most clinically actionable PGx genes, and the other is an oncology panel designed to help guide therapeutic decision-making across all cancers.

Guanghui Hu, the company's VP of translational genomics, announced the upcoming clinical push at the consumer genetics conference in Boston last month.

Hu told PGx Reporter this week that the company expects to release its pharmacogenomic test, called PGxOne, by the end of next month.

"We are in the final stage of CLIA validation," he said. "And we have a partnership with [Coriell Life Sciences] lined up to launch it immediately when that is complete, so there are patient samples waiting for that already."

At the conference, Hu said that combining multiple pharmacogenomic genes and markers into a single sequencing-based assay carries several advantages over PGx testing that is conducted one gene at a time. He declined to detail what the cost of the PGx panel will be, but said that it will be priced competitively with currently marketed standard 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."

He said the company also believes that "it is becoming more and more clear that having all the information — all the gene tests at once — will be cost-effective so that doctors don't have to [order another] test every time they need more information."

According to Hu, looking at this potential cost benefit of the PGx panel will be part of a pilot study conducted when the company launches the test with Coriell later this year.

Hu said Genewiz's PGxOne will span a set of about 25 genes: 196 alleles and 112 amplicons — about 26 kilobases in all — including a number of CYP genes, VKORC1, SLCO1B1, and others. The panel includes markers that the company has determined through analysis of professional guidelines, literature, and under advice of groups like Coriell to be the most medically actionable.

In the future, as additional treatment-response linked areas of the genome are identified, Genewiz will continue to update the panel, Hu said.

At the conference, Hu presented data comparing variant calls using PGxOne against a CDC reference database in eight samples in which Genewiz's panel showed nearly 100 percent accuracy.

Following the release of the PGx test this fall, Genewiz will also commercialize a clinical cancer sequencing panel, OncoGxOne — a test designed to cover the full spectrum of genes harboring potentially actionable cancer mutations — by the end of the first quarter of 2014.

Hu said that the Genewiz cancer panel will be akin to what Foundation Medicine offers through its FoundationOne test, and will be intended to provide information physicians can use to potentially personalize treatment using targeted cancer therapies.

Unlike FoundationOne, however, Hu said the OncoGxOne panel will be slightly smaller, focused more tightly on only medically actionable genes. Because of this, he said the company can run the panel on the Illumina MiSeq instead of the HiSeq and reduce costs by half of what Foundation Medicine charges for its test.

He said OncoGxOne will also include chemotherapy-associated genes, a benefit Hu claimed distinguishes Genewiz's test from other cancer sequencing offerings.

Overall, the current panel contains 35 genes, according to Hu's conference presentation — 28 genes associated with targeted therapy and seven associated with chemotherapy response.

OncoGxOne joins a set of smaller cancer-specific panels the company already offers for research use. Genewiz also offers a research-use version of its PGx sequencing panel, which is broader than what will be included in the clinical version.

According to Hu's 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 company CeGaT told PGx Reporter sister publication Clinical Sequencing News earlier this year that it is currently developing a pharmacogenetic panel that includes more than 340 genes (CSN 8/14/2013).

In addition, researchers from the Pharmacogenomics Research Network and the Electronic Medical Records and Genomics, or eMERGE, consortium have said they are conducting a study to integrate genomic data from a sequencing-based pharmacogenomics panel with the electronic medical records of as many as 10,000 patients (CSN 11/14/2012).

The Medical College of Wisconsin has also developed a sequencing-based pharmacogenomics panel covering 35 genes (CSN 1/11/2012).

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