Thursday 28 November 2013

Myriad: school bully, or just sticking up for themselves?

Can some explain Myriad's strategy, other than using bullying tactics to kill competition I don't get it? Is there any real prospect of the law siding with their point of view? I hope not. And since the US market has some pretty wonderful advertising (surely you all remember the PGM vs MiSeq ad series), surely Myriad will end up damaging their own reputation with consumers therefore shooting themselves in the foot?

Coverage of the Myriad litigation this Summer by Genomics Law Report bloggers and says that with Myriad's BRCA patents expiring in 2015 the field would open up to competition anyway. The $400M they earned from BRCA testing in 2012 may be a reason they don't want new entrants to the market until 2015, as they stand to make nearly $1B over the next 2 years! Ultimately we should see panel-based rather than single-gene testing becoming commonplace. And the problem of confirmatory testing Genomics Law Report also discusses goes away entirely.

Will consumers vote with their feet once the market opens up? I guess we'll just have to wait and see.

At the bottom of this post is one of Counsyl's clinical reports.

Who else offers BRCA testing: If you want to find a provider of next-generation sequencing tests for compex diseases, or just BRCA1&2 then simply follow Myriad's trail of lawsuits (links to coverage are from GenomeWeb): InVitae, Ambry GeneticsGene-by-Gene, GeneDX, Quest Diagnostics, Counsyl. I'm pulling together a list of the genes covered by different providers and hope to include it in a future post.

Ambry Genetics: Offer clinical genetics services and have 26 genes in their Cancer Next panel, including BRCA1&2.

Counsyl: Uses targeted genotyping of 398 variants associated with 100 diseases and next-generation sequencing of 1427 exons in 98 genes at high coverage. They say in their clinical reports that "mutations may not be detected in areas of lower sequence coverage. Triplet repeats and large deletions and duplications may not be detected. Small insertions and deletions may not be as accurately determined as single nucleotide variants. Genes that have closely related pseudogenes are not well analysed by this method".

Foundation Medicine: I've not see coverage of Myriad suing Foundation, they do include BRCA1 & 2 in their 250+ gene F1 test but perhaps as it is aimed at somatic rather than germline the case is not so clear?

GeneDX: 7 cancer gene panels and 14 single-gene tests for inherited cancers. The
OncoGene Dx: Comprehensive Cancer Panel for instance covers 35 cancer genes. They use Agilent SureSelect for target capture and sequence on Illumina's MiSeq using PE150bp reads; all variants are currently confirmed by Sanger sequencing. At the same time exon-level oligo arrayCGHis used for CNA analysis.
Gene by Gene: includes BRCA1&2 as part of their $995 DNA Traits test. The same people also run Family Tree DNA for genealogical testing.

InVitae: offer BRCA1&2 as part of their 150 gene panel which you can order as single-gene tests or as any combination of tests all for the same $1500 price.

Quest Diagnostics: BRCA1&2 sequenced with their BRCAvantage test. They also have a Peanut allergy test!

Reporting clinical results from NGS: I think this shows how simply complex information can be communicated. There is a lot of discussion about how difficult NGS data is to report, but when I see reports from people like Counsyl, Foundation Medicine and 23andMe I think we can get the important stuff across pretty well already! 

1 comment:

  1. Hi James! Great summary-- FYI: Invitae recently updated our test menu to include more genes. And I'd like to suggest adding a third metric to any provider comparisons: turn around time(sample receipt->report delivery). Test quality & cost are often focused on primarily, but turn around time can be critically important as well.
    I'd love to see a comparison on all three measures (Invitae has a 2 week sample->report turn around time FWIW).
    Feel free to drop me a line if you want more specifics!


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