0:00

Okay, let's look at some of the validation studies,

0:03

and I'll go through these pretty quickly

0:04

because I think you may be familiar with these.

0:07

Uh, this was the large, uh, Akron trial, uh,

0:10

published in the New England Journal

0:11

of Medicine back in 2008.

0:13

It was a multi, uh, site trial, let's see, 15 sites, uh,

0:18

including over 2,500 asymptomatic adult patients.

0:24

Uh, used state ofthe art technique with a stool tagging, um,

0:28

reader certification was performed.

0:30

So in order to qualify to be a reader, you had

0:33

to pass the test and achieve an accuracy of over 90%.

0:38

Um, and you can see the results were excellent.

0:41

Uh, there is, uh, increasing, uh, sensitivity

0:44

with increasing polyp size.

0:46

So when we get to the clinically significant size of 10,

0:50

10 millimeters and above,

0:51

you can see a 90%, uh, sensitivity.

0:54

Now, when you look at six millimeters

0:56

and above four, at about 78% sensitivity, specificity, uh,

1:00

throughout all categories was in the high eighties.

1:05

These are additional, uh, studies, um, performed in Europe.

1:08

The MDIC study, you can see that, uh,

1:11

these were also asymptomatic average risk patients

1:14

per polyp sensitivity.

1:16

The six millimeter and larger and this nine millimeter

1:19

and larger were in the, uh, low 90th percentile

1:23

per patient sensitivity.

1:25

Again, uh, 91%, 92% with high specificity.

1:29

And again, in the Italian study, the impact study, uh,

1:33

really the results, uh, parallel, I think the Akron trial,

1:37

you can see for nine millimeter

1:38

and 10 millimeter larger polyps at over 90%,

1:42

uh, sensitivity.

1:44

And then, um, specificity, uh, also parallels pretty much

1:47

what we saw in the Akron trial, the high eighties,

1:51

and then at 90% with the six millimeter.

1:55

And then this is a recent meta-analysis

1:57

that looked at 14 studies over 3,500 patients.

2:02

And again, you can see excellent sensitivity

2:04

for the 10 millimeters and above at 91% specificity of 98%.

2:10

So perhaps with these later studies

2:12

and tagging specificity, um, has increased and.