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No. of Recommendations: 2
S1 here:
https://www.sec.gov/Archives/edgar/data/1699031/000162827920...

Lots of snippets below:

Our multi-cancer early detection test, Galleri, is designed as a screening test for asymptomatic individuals over 50 years of age. We plan to commercially launch DAC after Galleri in the second half of 2021 as an LDT. We are also developing a minimal residual disease (MRD) test, designed to enable blood-based detection with or without tissue, and without the need for a personalized assay, as well as other post-diagnostic applications....

In a clinical study, an earlier version of Galleri identified over 50 types of cancers, over 45 of which lack recommended screenings.

Grail states their target audience is 50-79 years of age - (107mil in US)... but... They specifically discuss their market they aim to address in 2021 & 2022:
-Large, self-insured employers (estimated total addressable U.S. market: 24 million people). 
-Progressive, integrated health systems (estimated total addressable U.S. market: 27 million people)
-Physician-directed channels, including concierge practices and executive health programs (estimated total addressable U.S. market: 1 million people)

*** Wait- no medicare/medicaid? Not initially, they do not even mention medicare/medicaid until page 95 or so. They pretty much say they are not going to even attempt to get by medicare/medicaid until 2023/2024; Which I imagine is when their next batch of data is due.

They go on to say...
Every year in the United States, more than 12 million patients are subject to potentially invasive and time-consuming diagnostic workups. We estimate 2.4 million of these patients are already referred to a specialist doctor for a cancer diagnostic workup, and this represents our initial addressable market in the United States. Many of these patients, particularly those with non-focal symptoms, undergo several months of tests before they receive a cancer diagnosis. Our engagement with physicians indicates they would value tools to help triage cases with non-localizing concerning signs and symptoms, equivocal imaging or lab findings, where biopsy may be challenging due to anatomy or concurrent medical conditions, or where there has been other failure to make a diagnosis.

Fuma's take: sounds nice in theory, but there is a subset of the population (both patients and providers), that may not take an expensive drug test over an invasive test to placate everyone. Particularly when "specialists" get paid alot more for procedures than lab draws.

One thing that I didnt realize bashing these tests earlier, is how poor everything else does (ie, scopes, mammos, etc). I know they were not great, but didnt really how not good they were!

test, positive predictive value & false positive rate
galleri: 43% …. 7,000 / million
mammo 4.4% … 100,00 / million (1 in ten!)
pap smears / cervical cytology 19% … 74,000 / million (1 in 13 or so!)
stool testing 1.2% … 123,000 / million (more than 1 in ten!)
PSA testing for prostate CA 30% … 100,000/million
chest CT for lung CA 3.8% … 128,000 / million


a positive predictive value (PPV) of 100% means that every time you get an abnormal test, that it absolutely means its cancerous. PPV of 20% means that only 1 in every 5 abnormal tests actually has cancer. basically, you want the PPV to be as high as possible to minimize the number of extra tests done. You also want the lowest false positive rate possible. Galleri hits the mark on both accounts. The question is how do you explain not getting a CT chest to a pulmonologist following you for lung cancer? for to not get a Pap to a GYN?

Guardant actually isnt developing a "one size fits all" blood test as a screen for multiple cancers at once...

so GRAIL is swinging for the fences, but trying to cater to a higher end crowd early on. Big financial backing, but nothing on the market yet. Not sure I'll get in super early on this one like I did with 10x genomics, but definitely will be watching.
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