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PerkinElmer Says It Will Still Sell Signature Genomics Microarrrays, Software Outside US

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NEW YORK (GenomeWeb) – PerkinElmer will continue to sell microarrays and software developed by Signature Genomics, despite its decision to shutter the company's laboratory services business.

A company spokesperson told BioArray News that PerkinElmer will make Signature Genomics' products available to its clients outside of the US.

PerkinElmer has sold Signature Genomics' products since it paid $90 million to acquire the Spokane, Wash.-based company. At the time, Roche NimbleGen manufactured Signature Genomics' comparative genomic hybridization oligonucleotide arrays, and PerkinElmer agreed to sell and support the products outside of the US, while Roche retained its right to sell the arrays to its US customers.

After Roche shuttered most of its NimbleGen business in 2012, Agilent Technologies began manufacturing Signature Genomics' arrays. It is unclear why PerkinElmer can only sell those arrays outside of the US. The spokesperson did not respond to additional queries about the state of the business.

PerkinElmer currently sells two catalog arrays based on Signature Genomics' designs. The first, the CGX Oligo Array, covers 245 known syndromic regions and 980 functional genes, and is available in three formats: CGX, an 8-plex array; a higher-density, 4-plex array called CGX HD; and a 4-plex array called CGX-SNP that contains SNPs for detecting uniparental dysomy and loss of heterozygosity.

PerkinElmer also sells a Signature Genomics-designed array for cancer cytogenetics. The CGX Onco Array is available in a 4-plex, 180,000-marker array format, and covers about 2,410 cancer relevant regions. All of PerkinElmer's CGX Oligo and Onco Arrays are marketed for research use only. Agilent, meanwhile, is working toward submitting its platform to the US Food and Drug Administration for clearance later this year.

A third component of the Signature Genomics offering is its software. PerkinElmer sold access to Signature Genomics' Genoglyphix software to CGX Oligo customers and its Oncoglyphix software to CGX Onco Array customers. Both web-based programs offer data visualization tools as well as access to Signature Genomics' tens of thousands of cases.

While Signature Genomics will continue to live on via PerkinElmer's product offerings, the company decided to shut down its services lab, which employed about 80 people. The PerkinElmer spokesperson said this week that the "primary driver behind the decision was the increasingly challenging reimbursement environment for lab services that would not permit us to continue to provide Signature's high-quality offering to physicians."

The company previously said that competition from next-generation sequencing-based noninvasive prenatal testing was also at play in its move. PerkinElmer distributes Verinata Health's verifi test for high-risk pregnancies. The PerkinElmer spokesperson did not respond to questions about what role PerkinElmer's involvement with Verinata, an Illumina company, might have had in its decision to shutter Signature Genomics.

Affymetrix, a vendor that sells chips for chromosomal microarray analysis including its FDA-cleared CytoScan Dx Assay offering, did comment on PerkinElmer's decision during a recent earnings call.

When asked if Affymetrix had experienced similar challenges related to reimbursement and NIPT, COO Andy Last said that the company has not seen "any major shifts in buying patterns or trends from our business point of view."

He also said that the FDA clearance of the CytoScan Dx Assay might be helping the company gain reimbursement for its test. "We're seeing signs of it increasing coverage from payors as a consequence of the clearance and so we expect that to continue," Last said. At the same time, he characterized the reimbursement environment for CMA as "very competitive and strange right now."

Arup helps out

At least one laboratory that offers CMA has responded publicly to PerkinElmer's decision to close Signature Genomics. Salt Lake City-based Arup Laboratories posted a Signature Genomics FAQ on its website to assist Signature Genomics clients with moving to Arup Labs for its CMA services.

According to Arup, it was contacted by PerkinElmer and asked if the company could recommend Arup to its clients as an alternative laboratory. As detailed in the FAQ, Signature Genomics clients can submit the same paperwork and test kits to Arup for analysis. Arup said that it has also developed kits that are comparable to Signature Genomics' kits, as well as a comparison chart to identify Arup test equivalents.

Arup Labs did not respond to a query about its role in aiding former Signature Genomics clients in time for this publication.

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