Here's the part you conveniently left out:
"Dr. Patricia Golden, a family medicine doctor at Wheaton Franciscan Medical Group in Franklin, said the task force upgrade will lead more doctors to use Cologuard.
“With the task force backing, this is not experimental,” Golden said. “This is an appropriate standard of care.”
Exact Sciences and high-profile organizations such as the American Cancer Society and Mayo Clinic asked the task force to upgrade Cologuard in its final determination.
In the final ruling, the task force listed Cologuard and virtual colonoscopy along with colonoscopy, flexible sigmoidoscopy and other stool tests.
...James Stancel, a lawyer in Washington, D.C., who served as acting general counsel for the U.S. Department of Health and Human Services, said insurers have to cover Cologuard because the task force listed it with the other tests in its “grade A” recommendation for colorectal cancer screening.
“It must be covered at zero cost-sharing,” Stancel said."
The CFO stated that this coming quarter will be peak Operating expenses for the next several quarters, also that they see test costs declining to: $190 this coming quarter then to $150 or so early to mid next year and longer term to about $130 per test. That represents 50%, 61% and 66% gross margins respectively.
Because it's the kind of quick unsubstantiated rumor trader's think can move the market quickly so they can maximize their gain. I guess they must think there are a lot of investors that will go out and make a trade based on some off-handed comment on a public bulletin board.
Long side it's : "Buyout coming!!" Short side it's: "Dilution Imminent!"
I had the same reaction to that you did. It's odd that they'd just drop that info with no follow-up or at least a date when they'll release more about it.
Actually it does, that's why they did the modeling themselves and put it in their report. There aren't longitudinal studies to support 10 year colonoscopy either or 1 year FIT. All the tests were evaluated in this report using the models I mentioned.
They provided stats on Benefits, Harms and Burden for all tests including 3 year Cologuard ("FIT - DNA every 3 yr)" based on:
"Outcomes are from Cancer Intervention and Surveillance Modeling Network (CISNET) models, which include the Simulation Model of Colorectal Cancer (SimCRC), the Microsimulation Screening Analysis (MISCAN) for Colorectal Cancer, and the Colorectal Cancer Simulated Population model for Incidence and Natural History (CRC-SPIN)."
You can find it here: "JAMA June 21, 2016 Volume 315, Number 23 pg: 2569"
Of course you'd actually have to have read the report to have seen it, which is probably way too "pump-tard" for you.
Well that's the big question isn't it. Differences of opinion about that are what make a market.
I'd say yes it makes much more than a $400M difference since it allows a clear path to HEIDIS and other quality metrics, and completely changes the negotiating position of Exact with regard to Insurance companies. That means broader physician acceptance and more lucrative contracts with insurers that will happen much quicker. It also means that Cologuard will qualify as an "A" rated preventive care test which means that Medicare and many private insurers will cover it with no co-pay regardless of whether the patient's deductible has been met.
That translates to a lot more sales a lot sooner in my estimation.
Last week I took my aunt to our local University medical center to have her second colonoscopy (my Aunt is at increased risk of CRC, so MD wouldn't Rx Cologuard). She had done the new improved prep using the newer bowel cleaning solutions. Of course, as expected she developed diarrhea. She wasn't quick enough in one of her nighttime bathroom trips and had a minor accident and cleanup. The hospital is about 15 min away and the morning of we had to stop on the way and she had another minor accident with cleanup (luckily she'd brought extra underclothes).
In the Endoscopy waiting room we saw two people with underclothes in plastic bags and two other women talking to each other about how they'd had accidents as a result of not making it to the toilet on time.
So the 'ick' factor narrative is that patients will reject Cologuard because they'll be put off by "interacting with their own stool". But I'd be willing to bet that in the majority of Colonscopies patients are forced into much more "interaction with their own stool" during Colonscopy prep then they'd ever be using Cologuard.
The original draft was ambiguous as to whether it would be covered. We argued it would be, and from the statements made by the USPSTF in the final, we were right; that was their intention. However it probably would have been a battle with insurance companies over mandated coverage if they draft language had stood unchanged, and the USPSTF wouldn't have intervened because that would be unseemly.
But they've taken the steps in the final draft to remove all doubt, plus they've provided stats from cologuard used in a 3 year interval which is a big win for the product.
From Mayo Clinic "Clinical Updates":
*******Quote [items is brackets are mine]
= Sensitivity of Cologuard for CRC was 92.3 percent overall and 94 percent for the earliest and most curable cancer stages [Stages I & II] — on a par with colonoscopy. In contrast, sensitivity of FIT for CRC was 73.8 and 70 percent, respectively.
= Detection rates for polyps with high-grade dysplasia were 69.2 percent with Cologuard versus 46.2 percent with FIT; detection rates for serrated sessile polyps measuring 1 cm or more were 42.4 percent and 5.1 percent, respectively.
= Specificities for Cologuard and FIT were 90 and 95 percent, respectively, for patients with negative findings on colonoscopy. [These are "clean colon" specificities]
FIT performs poorly on early stage cancer and precancers, and it's virtually unable to detect Sessile Serrated lesions, since they don't bleed. The 5% rate on Sessile lesions is probably serendipitous detections, where Sessile polyps were paired with other polyps that bleed. Even when you take into account the increase in programmatic sensitivty you get from 1 year intervals, FIT can't detect Sessile polyps.
There's emerging evidence that Sessile Serrated polyps play an outsized role in undiagnosed CRC, interval cancers and especially in Colon Cancer deaths. This seems to be because cancers that begin as Sessile polyps are much more aggressive than those from more common polyps.
Yep, good way to look at it. Although I think Exact is one of the first companies to usher a cancer screening test through the regulatory process post ACA. So in a way they've pioneered things so that those that follow better understand the pitfalls.
But yes, it gives them a decent sized moat.
Yes, I've read various posts from employees on different websites, I think they've got a little of "grew too fast" disease with regard to staff quality. That and assuming that lots of graduate degrees means you'll be a good middle manager. But it's hard to tell from the outside, since typically it's the malcontents that tend to speak out.
I've appreciated the posts from the regulars on this board especially you and couple of others. That a Yahoo message board would consistently, over several years, be one of the best sources of information on this company has got to be a huge anomaly. :)
I hear ya! :) Yes since 2002 after reading a column on "The Street's" website by Odette Galli about Exact, frickin' 14 years, I almost hate to admit it. Plenty of humbling moments for sure.
If I'd known what an endless gauntlet of bureaucratic hurdles the regulatory process is, I don't know if I would have invested. Seems like there's always another one to jump over.
Good luck to you Ranjovance.
The mandated coverage and quality rating system have a 1 year lead time. Although I'm sure insurance companies will recognize this is inevitable in their negotiations, some doctors may not budge until participation in the rating system is in place, since technically, although extremely likely to happen, this is a decision not yet made.
well... it costs $600.00, maybe that's just a "few" to you but I think most people would disagree.
I feel sorry for you poor guys, this is institutional buying not retail, you're not going to affect the share price with a bunch of frantic all-caps desperation posts on a Yahoo message board.
Cover and give us all a break from your mindless spam.