0:00

Okay, let's, um, move on to, um,

0:04

actually this is a graphic that I developed to, uh,

0:06

show you the evolution of CT colonography over the years.

0:10

And CTC was first introduced, uh,

0:13

an SAR meeting back in 1994.

0:16

And then for a 10 year period leading up to 2007,

0:20

the major validation trials, uh, were performed.

0:23

Both single and, uh, multicenter, um,

0:26

animal models were evaluated.

0:28

We moved from single detector to multi detector ct.

0:32

We moved from room air insulation to the use

0:34

of carbon dioxide insufflation, um,

0:37

and then, uh, improved hardware

0:39

and software, uh, for graphical display on workstations.

0:44

Many of you are aware that the Akron

0:47

National CT Colonography trial was published in the New

0:49

England Journal of Medicine back in 2008

0:52

with excellent results, uh, showing, uh,

0:55

greater than 90% sensitivity of large polyps.

0:59

Uh, this led to the American Cancer Society in the same

1:02

year, endorsing CTC

1:05

and joint guidelines, uh, for screening.

1:09

However, um, the US Preventive Service Task Force

1:13

and then Medicare in 2008

1:15

and then in 2009, decided that it was insufficient evidence,

1:19

uh, to provide coverage for national screening.

1:23

So since then, there's been continued, uh,

1:26

work performed research published,

1:28

looking at the three main areas that, uh,

1:31

that Medicare has had an issue with,

1:33

which is radiation dose,

1:35

which I think is no longer currently a real issue,

1:39

extra colonic findings, uh,

1:41

and, uh, proper management of those,

1:43

the validation in Medicare age patients, again,

1:46

there have been multiple studies that have evaluated this

1:49

and showed that CTC performs well, um, in the age 65

1:53

and older, um, patient cohorts.

1:56

Um, on a positive note, since uh, 2009, uh,

2:00

we've noted particularly in the states that insurance, uh,

2:04

companies, private payers, have continued

2:06

to increase coverage, uh, not only for diagnostic ct,

2:10

but for screening as well.

2:12

Um, and since 2009, we've seen significant, um,

2:16

dissemination of CT colonography

2:18

really throughout the world.

2:21

2013, the FDA in the US um,

2:25

held a special joint panel, uh,

2:28

that ended up supporting screening CT colonography

2:31

and said that it was both a safe and an accurate exam.

2:35

The US Preventative Service Task Force, which back in uh,

2:39

2008, uh, had not approved CTC in 2016, uh,

2:44

decided to include CT colonography as a valid option

2:48

for colorectal cancer screening.

2:49

So that was more good news.

2:51

However, in 2017 when, um,

2:55

CT colonography went back to Medicare, uh,

2:58

They decided that they would

3:00

deny a national coverage determination.

3:04

Then the American Cancer Society, again decided to endorse

3:07

and support CT Colonography in thousand 18 as AL option

3:12

for colorectal cancer screening.

3:13

That pretty much brings us up to the president.