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Emory Offering Verinata's Verifi, Moving its Genetic Testing Portfolio into International Markets

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Emory Genetics Laboratory is now offering Verinata's noninvasive prenatal test, Verifi, to physicians, plans to soon launch a number of cancer panels, and is beginning to expand internationally — inking molecular diagnostic partnerships with Mexico's Genomi-K and AITbiotech in Singapore, Clinical Sequencing News has learned.

Additionally, to keep up with its expanding capacity and range of tests, the laboratory has hired five new directors that will join EGL full time within the month. Zunyan Dai from Quest will serve as director of the Cytogenetics Laboratory; Daniel Sharer from the University of Alabama, Birmingham and Patricia Hall from the Mayo Clinic will join as directors of the Biochemical Genetics Laboratory; and John Alexander from the University of Alabama, Birmingham, Yuan Xue from the University of California, Los Angeles, and Alice Tanner from Emory will join as directors for the Molecular Genetics Laboratory.

EGL has also purchased an Illumina HiSeq 2500 system, adding to the three Illumina MiSeqs and four Sanger systems it uses for clinical purposes and three of Life Technologies' Ion Torrent PGMs that it uses for research and preliminary experiments.

Madhuri Hegde, EGL's executive director, told CSN that the lab decided to contract with Illumina's Verinata after evaluating the four noninvasive prenatal tests currently on the US market and discussing the various options with obstetricians and gynecologists in Georgia.

According to Hegde, a major concern of the Ob/Gyns was the tests' no-call rates, and she said that after evaluating the most recently published data, including Verinata's most recent study in Prenatal Diagnosis, she determined that the firm's no-call rate was the lowest.

"We also felt strongly about the fact that Verinata has been bought by Illumina, and Illumina is a leader in next-generation sequencing and is highly investing in R&D to extend the capabilities of NIPT," she said.

For instance, she said Verinata is researching the addition of microdeletion and microduplication testing, and Emory is interested in working with Verinata to do clinical validation studies for those applications.

As part of the deal with Verinata, physicians order the test through Emory, samples are sent to Verinata's lab for testing, and then follow-up — including genetic counseling or an amniocentesis in the case of a positive result — is done through EGL.

Previously, Hegde had said that Emory was also considering developing its own noninvasive prenatal test (CSN 3/27/2013), however she said that the laboratory is leaning toward applying the technology to other applications, for instance in detecting fetal single-gene mutations, microdeletions, and microduplications. Such tests would be administered in the case where there has already been familial testing, there is a known mutation in the family that has shown segregation, and the parents want to do prenatal testing of that specific disease-causing mutation.

Aside from prenatal testing, Hegde said that the laboratory is developing a sequencing-based pan ethnic carrier screening test and is "very close to finishing our cancer validation," including a next-gen sequencing-based hotspot panel as well as both somatic and germline mutation panels.

Hegde said that the laboratory has a hereditary cancer test that includes the BRCA1 and BRCA2 genes that is "developed and ready," but it is being "cautious" because of ongoing patent litigation.

In June, the US Supreme Court ruled against several of Myriad's patent claims on isolated BRCA1 and 2 gene sequences. As a result, a number of laboratories launched hereditary cancer tests that include analysis of the BRCA1 and 2 genes, prompting Myriad to sue, alleging that those companies infringe on a number of claims in patents that were not struck down (see PGx Reporter 7/10/2013).

"So, we're holding off, but our test is ready," Hegde said.

In terms of the lab's international expansion, Hegde said that the partnerships with Genomi-k and AITbiotech are just the beginning. The lab is also looking to partner with centers in the Middle East, Japan, and Africa, and is already receiving a large number of samples from Europe.

The Genomi-k and AITbiotech partnerships include contracts to provide the molecular diagnostics companies with the full range of genetic tests offered by EGL. "They have some specific tests that they are more interested in," Hegde said, "with the next-generation sequencing tests at the top."

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