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New Products Posted to GenomeWeb: Oct 23, 2015

Ambry Genetics Epilepsy Genetic Testing Panels

Ambry Genetics has launched a new suite of seven genetic testing panels for epilepsy. The new epilepsy tests include: EpiFirst-Neonate, a targeted panel of genes most likely to cause neonatal seizures; EpiFirst-Fever, a targeted panel of genes most likely to cause febrile seizures; EpiFirst-IS, a targeted panel of genes most likely to cause infantile spasms; EpiFirst-Focal, a targeted panel of genes most likely to cause non-lesional focal epilepsy; PMEFirst, a targeted panel of genes more likely to cause progressive myoclonus epilepsy; PMENext, a broad panel of genes known to cause progressive myoclonus epilepsy; and EpiNext, a broad panel of genes known to cause a variety of epilepsy syndromes.

Testing can begin with a targeted gene panel, and move to a broader panel if desired. Alternatively, the broadest panel could be ordered as the first test if appropriate for the clinical situation. The flexible model gives healthcare providers the ability to control and choose their testing approach to best suit their patient. Test can be ordered stating on Nov. 9.

Sera Prognostics PreTRM Test

Sera Prognostics has announced a program for limited commercial access to PreTRM, a proteomic biomarker blood test designed to provide an early, objective, and individualized assessment of a woman's risk of preterm birth. The test will be made available in limited locations in the US, beginning with selected clinical sites that participated in the Proteomic Assessment of Preterm Risk study. All testing will be conducted at Sera's CLIA-certified laboratory in response to orders from women's healthcare professionals. Following the early access outreach to physicians in selected markets this fall, Sera is planning for a wider national PreTRM rollout in 2016, the company said in a statement.

23andMe's Personal Genome Service

23andMe has launched a revamped Personal Genome Service with a redesigned site and more than 60 genetic testing reports on carrier status, ancestry, wellness, and personal traits. The service costs $199.

The new release comes after 23andMe received 510(k) clearance from the US Food and Drug Administration in February for a Bloom syndrome test. As part of the authorization, the FDA said it is classifying carrier screening tests as class II, and intends to exempt similar devices from FDA premarket review.

"We've worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing," 23andMe co-founder and CEO Anne Wojcicki said in a statement. "We are a better company with a better product as a result of our work with the FDA."

For more new products and services, please see the New Products page on our website.