Sep. 10 at 5:35 PM
$GRAL Question on Galleri Cancer Screening Test approval from @Monkey7779192 from FDA. The test attempts to diagnose the presence of 51 different cancers and beat clinical testing alone that tends to pick up earlier cancers better, because they are not seeding the blood with enough tumor DNA, because they have not invaded the tissue enough among other possible factors....
Formal FDA review is on Sept. 23rd. Hard to say how they will vote. It depends on whether they determine it is cost effective. The increased pickup in early dx is between 16% and 19% depending on whether you look at Stage I and II patients vs. Stages I -III patients. So if you screen the entire pop. to pick that up, is it cost effective? That will drive the approval or non-approval. Cancer drugs that only extend life by 4 months get approved, so it could happen to this diagnostic test for cancer.
At ~
$750 per test, running standard annual screening across a population requires roughly
$350,000+ in pure testing costs alone to pick up a single early-stage cancer. (that's from Gemini's analysis)
The test also has the ability to pick up cancers for where there is no screening, for example...
Esophageal Cancer: 57.1% drop in Stage IV diagnoses during follow-up rounds.
Colorectal Cancer: 34.4% drop in Stage IV diagnoses during follow-up rounds.
This means that it could break out testing subsets of patients who have risk factors for esophageal and the other essentially unscreenable cancers and offer specific vs. buckshot testing for all common cancers.
I worked with Gemini to look at the data on the total group of G-Test Pos. Clinical Neg. patients, meaning their cancers were missed by clinicians. Note that 82% of these remain unsolved in terms of IDing a clinically evident tumor. Longer term follow-up will be required to see how many of these are just "early detection." In other words, the results could improve further over time...
The table shows the breakdown of tumors detected on follow-up from this G--Test Positive Clinically Negative subgroup by Stage...
IMO.