Elissa Levin

01:00 Helix introduces the GenePrism, a test for healthy people, that looks at the 59 actionable variants flagged by ACMG

07:58 Is it DTC or consumer-initiated testing?

10:32 Building in easy access to genetic counseling without a cost barrier: will they use it?

16:46 We use the phrase clinical grade testing a lot these days. What does it mean?

23:30 Were they surprised that the media saw GenePrism as a test comparable to 23andMe? Why yes, they were…

29:52 Helix has the full exome there: how did they pick the ACMG 59 as their place to set bar?

33:22 GenePrism is $259. For newcomers to the Helix platform, the exome is $40. How does Helix justify a price this low? “We work under the premise that this is a lifetime engagement…”

35:17 Has the FDA stepped away from regulating DTC genetic testing?

39:02 Elissa says she worries more about under-regulation than overregulation.

40:47 Elissa and I agree: we need some new vocabulary for DTC genetic testing.

Elissa Levin was one of the first genetic counselors to work in the direct-to-consumer sector, starting at DNA Direct (remember that?); she’s been at Illumina-spinoff Helix for about 3 years. Helix runs a DTC marketplace, offering an the all-purpose DNA test (exome plus microarray) that can be queried by any of their testing partners. Now Helix has partnered with PerkinElmer to produce a new entry for its own marketplace -- the PerkinElmer GenePrism test.