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Signature Genomic Labs Launches MarkerChip, Licenses Abbott’s CGH IP to Fend Off Suits

NEW ORLEANS— Signature Genomic Laboratories last week made available a new array for use in its comparative genomic hybridization-based cytogenetic services.
Separately last week, Signature said it had obtained a license from Abbott to a suite of patents related to array CGH technology as a way to shield itself from potential future litigation by the life sciences giant and other array players.
According to Signature officials, the Signature MarkerChip differs from the firm’s original SignatureChip and from rival arrays in that it is a diagnostic chip designed only for characterizing supernumerary chromosomes. Its appearance opens a new front in CGH array product proliferation.
“There are kids that have 47 chromosomes instead of 46. It helps to know the chromosomal origin of this extra chromosome because some markers have well-characterized phenotypes in the medical literature. So this furthers the diagnostic capabilities of cytogenetics,” said Signature CEO Lisa Shaffer.
To provide the kind of coverage that will enable Signature to characterize these extra markers, the new MarkerChip has “extensive coverage in the pericentromeric regions of the chromosomes,” according to Bassem Bejjani, Signature’s medical director.
Shaffer and Bejjani spoke to BioArray News at the American Society of Human Genetics meeting, held here last week.

“There is an observation that a lot of microdeletion-related syndromes involve deletions close to the pericentromeric regions. In addition to identifying those deletions and duplications in the pericentromeric regions, we wanted to identify and characterize marker chromosomes and the marker array will be able to identify them and size them correctly,” Bejjani said.

Bejjani said that where the SignatureChip has pericentromeric coverage on average of three BACs for every region, the new MarkerChip has an average of 23 BACs per pericentromeric region.

“For the majority of these markers the chromosomal origins are never identified because we don’t know what they are and it’s hard to characterize them with current cytogenetic methods. Now we can characterize these markers and correlate them with different phenotypes,” Bejjani said.

Shaffer said that the company’s MarkerChip service will work the following way: The clinician “identifies that there is a marker chromosome present in the individual, and sends [the] blood sample from the patient to Signature to determine the chromosomal origin and size of the imbalance.”

In other cases, Signature, after receiving a patient sample from a clinician, “may identify that the patient has a marker chromosome by using the SignatureChip and then run the sample again on the MarkerChip and report the identification and size of the marker to the physician,” Shaffer said.
IP from Abbott
As it rolls out the MarkerChip service, Signature is trying to clear up any remaining intellectual property issues that could leave it vulnerable to suits from other array companies, including Abbot Molecular.

“We are very happy to have come to a legal understanding with Abbott. It was always a dark cloud over us not knowing how Abbott was going to react to our service.”

Last week the company said that it has non-exclusively licensed from Abbott Molecular a suite of patents related to the use of comparative genomic hybridization. The deal was concluded eight months after Signature licensed Affymetrix IP related to high-density microarray technology (see BAN 2/14/2006).
”We are very happy to have come to a legal understanding with Abbott. It was always a dark cloud over us not knowing how Abbott was going to react to our service,” Shaffer said. “So now I am glad we can move forward.”
Shaffer added that Signature has filed an application for its SignatureChip with the US Patent and Trademark Office, and that the new MarkerChip is covered through the same application.
Because Signature operates as a CLIA-approved laboratory using a homebrew assay, its licensing deals could establish a pattern of licensing in the developing CGH services market. Amit Kumar, CEO of CombiMatrix, the parent rival CombiMatrix Molecular Diagnostics that recently introduced a similar service, declined to discuss IP issues surrounding CMDX’s CGH platform with BioArray News.
Another rival, Spectral Genomics, which was acquired by PerkinElmer this year and sells CGH chips to some labs in the US such as LabCorp, also took a license to Affymetrix array patents in 2003 (see BAN 10/22/2003).

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