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GeneDx Launches Suite of Inherited Cancer Panels, Including BRCA1 and BRCA2 Genes

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In the wake of the US Supreme Court's decision to strike down Myriad Genetics' patents on isolated BRCA1 and BRCA2 gene sequences, GeneDx this week become the latest laboratory to launch sequencing-based tests for inherited cancer that include those genes.

GeneDx's next-gen sequencing inherited cancer tests include a comprehensive cancer panel of 35 genes, a 26-gene panel for breast and ovarian cancer, an 18-gene panel for pancreatic cancer, an 18-gene panel for colorectal cancer, and an 11-gene panel for endometrial cancer. All panels, which are marketed as OncoGeneDx, also include deletion and duplication analysis. The comprehensive panel, breast and ovarian panel, and endometrial panel will include the BRCA 1 and 2 genes.

Additionally, GeneDx has launched Sanger-based tests, including one that combines sequencing and deletion/duplication analysis of the BRCA1 and BRCA2 genes and an Ashkenazi Jewish panel for the three common Ashkenazi Jewish founder mutations in BRCA1 and BRCA2.

GeneDx joins a small but growing number of laboratories that are now offering testing for BRCA1 and 2 mutations, either as standalone tests or included within a larger inherited cancer panel, following the Supreme Court's June ruling against gene patents (CSN 6/26/2013).

Ambry Genetics, Ethigen, and Gene by Gene's DNA Traits were among the first labs to launch tests. As reported by sister publication Pharmacogenomics Reporter, Myriad has sued Ambry and Gene by Gene, alleging that the firms infringe on a number of claims in patents that were not struck down by the Supreme Court (PGx Reporter 7/10/2013).

Ambry and Gene by Gene have in turn countersued, alleging anti-trust violations by Myriad.

Whether or not GeneDx will now also be pulled into the legal fray remains to be seen. A spokesperson for Myriad declined to comment on whether the firm would pursue legal action against GeneDx. Sherri Bale, GeneDx's managing director, told Clinical Sequencing News that despite the lawsuits Myriad has brought against other companies, "we've done our homework and we're confident in our legal position."

GeneDx's next-gen based inherited cancer panels are being run on the Illumina MiSeq system using Illumina's TruSeq enrichment technology and include microarray-based deletion and duplication analysis. Sanger sequencing is used to confirm all potentially pathogenic variants as well as to fill in areas of low coverage. Turnaround time for the panels is around four weeks.

Bale said that the company is "currently in negotiations with several insurers for pricing," so she didn't comment on what the cost of the panels would be. However, she said that the cost "will most certainly be competitive" with other inherited cancer panels. Additionally, Bale said she expects the panels to be covered by payors, given the company's success at gaining reimbursement for its other diagnostic tests.

Prior to the Supreme Court's ruling on Myriad's BRCA1 and 2 patents, Myriad held a monopoly on testing for the mutations, which confer elevated risk for inherited forms of breast and ovarian cancer. Since it first launched its BRACAnalysis test 17 years ago, the company has built up a database of BRCA1 and 2 mutations, which it has said will give it a competitive advantage over potential competition, enabling it to classify fewer variants as having unknown significance.

However, according to GeneDx, it too has its own database with more than 4,000 reference sequences and is adding more than 150 individuals per week to the database. Additionally, the company shares data with publicly curated databases such as ClinVar, and some experts have said that such public efforts could soon rival Myriad's proprietary database, diminishing the firm's competitive advantage for BRCA testing (CSN 5/22/2013).

Myriad, however, also plans to launch an NGS-based hereditary cancer panel in September on the Illumina HiSeq 2500, which will assess mutations in 25 genes related to six different cancers (CSN 8/14/2013). The panel will cost between $4,000 and $4,500 and have a turnaround time of about two weeks.

Regarding the potential impact of competitors' offerings, a spokesperson for Myriad told CSN that Myriad "has the advantage of having over a quarter of a million patient samples coming through our laboratory every year," which the company said will help expedite the process of characterizing the genetic information in the extended gene panel.

Aside from Myriad and Ambry Genetics, GeneDx will likely have to compete with other laboratories, including Emory Genetics Laboratory and Pathway Genomics, both of which have indicated intentions to launch next-gen sequencing-based inherited cancer panels that include the BRCA genes.

Bale said that GeneDx's "panels are made of the most appropriate and well-vetted genes that have clinical utility. We'll compete on price, service, quality, and our experience in doing next-gen sequencing panels."

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