Opportunities to advance multiplex technology

Video Transcript

• 00:00 - 00:14: I think there is a barrier around the lock when it comes to something like FDA clearance
• 00:14 - 00:21: or etc that having something that is completely open is not going to fly, potentially.
• 00:21 - 00:28: So what are your opinions on, you know, an openness and then there’s a point at which
• 00:28 - 00:29: you lock something?
• 00:29 - 00:35: Yeah, so pertaining to the question about, you know, whether we should be using and going
• 00:35 - 00:38: further into using triplex and things like that.
• 00:38 - 00:43: So I think it’s been shown in the literature actually that the more you use, the more the
• 00:43 - 00:49: parameters you use, the more you’re going to have granularity about a given situation
• 00:49 - 00:54: and then of course when you switch to translational medicine, you know, when your signatures have
• 00:54 - 00:59: been identified, then of course you can reduce your approach and use only those parameters
• 00:59 - 01:06: which are generating the variance in the dataset, which are therapeutically actionable.
• 01:06 - 01:14: But I think maybe the right question would be, you know, it’s all related to cost, right?
• 01:14 - 01:18: Using a lot of parameters simultaneously is going to be requiring a lot of resources,
• 01:18 - 01:21: bio-IT resources as well.
• 01:21 - 01:26: So if in the near future we manage to have those prices, you know, sink, maybe everyone
• 01:26 - 01:32: is going to be able to employ, you know, triplex technologies, you know, in their research
• 01:32 - 01:39: and then reduce it, you know, as it’s time to be switching gears to translational medicine.
• 01:39 - 01:44: So how did you feel about taking that kind of thing into the FDA at this point?
• 01:44 - 01:49: Yeah, so we have history with that, with NanoString, because we have a breast cancer panel actually
• 01:49 - 01:51: which has been FDA approved.
• 01:51 - 01:56: So this is being run as a, it’s called Prosigna, it’s being run as a clinical routine, clinical
• 01:56 - 01:57: diagnostics group.
• 01:57 - 02:02: And this is basically stemming from research, preliminary research that we have been carrying
• 02:02 - 02:03: on together with collaborators.
• 02:03 - 02:09: We started with, you know, a 770 gene signature panel and then we came up with those, you
• 02:09 - 02:13: know, refined signatures that are now FDA approved.
• 02:13 - 02:17: So I think it makes sense actually to be starting big and reducing the approach as students
• 02:17 - 02:20: move forward towards accreditation.
• 02:20 - 02:25: Berto, do you want to come in from a Fluidigm perspective in terms of that?
• 02:25 - 02:29: And still, the overview here is great as well.
• 02:29 - 02:32: So yeah, I mean, I pretty much agree with what has already been said.
• 02:32 - 02:37: I think that now, if I have to take a look, I believe at what we see the marketplace growing
• 02:37 - 02:40: really both in the multiplexing realm, etc.
• 02:40 - 02:44: I do agree with the fact that in the protein realm, we still don’t exactly know what we’re
• 02:44 - 02:45: looking for.
• 02:45 - 02:51: Because it’s true that protein analysis, multiplexing has not yet benefited from the scale of discovery
• 02:51 - 02:55: that we’ve had in, for example, single-cell RNA-seq, etc., where we can just do whole transcriptome
• 02:55 - 02:59: analysis, whole genome analysis, and really get everything in.
• 02:59 - 03:02: But the beauty of the technologies that are coming out now is that it’s actually allowing
• 03:02 - 03:06: us, and like what Bernd said, to actually start to refine those sort of markers that
• 03:06 - 03:07: we want to go and see.
• 03:07 - 03:11: And I believe that what we’re seeing now is that we are in the phase where we’re starting
• 03:11 - 03:14: to really try to understand exactly how many markers is enough.
• 03:14 - 03:18: Because up until now, we’ve seen that even all of the gold-standard companion diagnostic
• 03:18 - 03:23: tests, think of the PD-1 assays that are out there, aren’t sufficient enough to stratify
• 03:23 - 03:25: patients
• 03:25 - 03:29: So now we’re really in the phase where a lot of different groups, pharma companies, etc.,
• 03:29 - 03:32: are really trying to understand, okay, one isn’t enough.
• 03:32 - 03:33: Will two be enough?
• 03:33 - 03:34: Three be enough?
• 03:34 - 03:35: Four be enough?
• 03:35 - 03:36: Apparently, that’s not the case.
• 03:36 - 03:39: But we’re going really, I think also Bernd’s example is quite nice, and really trying to
• 03:39 - 03:45: understand, okay, where is that limit where we can really start to go in and do that stratification?
• 03:45 - 03:49: And as Alexander said, of course, cost is going to be a very big issue.
• 03:49 - 03:53: At the end of the day, if we want to bring this to the clinics, it has to be something
• 03:53 - 03:57: that is cost-effective, can be reimbursed at the end of the day, and can really also
• 03:57 - 03:59: be used to screen the patients that need to be screened.