Oncotype DX

Some genes get turned off and turned on erroneously in a tumor compared to normal cells.

and and we can measure that and so it's been probably over a decade now close to two decades from when some of the early studies profiling the gene activity levels of different tumor types were conducted based on all those studies that were done in the past a number of companies have developed tests where they've whittled down the list of genes that they think are most important to describe the aggressiveness of a cancer from a molecular kind of standpoint and so there's three widely available commercial assays that or tests that measure the gene expression level or the gene activity level of prostate cancers that can be used in in some way shape or form during management process of a patient's prostate cancer one is called decipher one's called oncotype dx and another one's called prolaris i think those are the those are the tests you're referring to correct

yeah

yeah so the the way these were initially developed was that patients who had who had their prostate cancers removed surgically what we call a radical prostatectomy the surgery where that i performed you know to treat patients for press with prostate cancer those tumors were taken and the rna and dna was extracted from those tumors and profiled, and then a short list of genes.

That is a highly testable molecular detail.

We also rely on multi-gene assays now, such as Oncotype DX, Coloprint, and Coldex.

These platforms analyze the RNA expression profiles of dozens of specific genes within the resected tumor specimen to mathematically quantify the exact risk of recurrence.

If a stage 2 patient is hesitant about accepting 6 months of oxaloplatin-induced neurotoxicity, a high-risk recurrence score on an Oncotec DX assay provides the objective data necessary to justify the treatment.

So it's really crucial that it's kind of assessed properly, accurately, and as quickly as possible.

And there's some factors that help to do it, you know, patient age, other histological factors like their tumor grade, their tumor subtype, but also more recently things like genomic variables, which is where like the Oncotype DX test comes in.

And it's been very useful, especially on the back of validation from the TaylorX trial, showing that patients in the low recurrence score, so those with between zero and around 11 up to 16 or up to 15, are shown not to benefit from chemotherapy and only to benefit from hormone therapies, whereas those in the higher end of the recurrence score, above 26 really, are shown to benefit materially from chemotherapy.

It's been extremely helpful.

Perfect.

So you're envisioning, of course, this need validation because this is one cohort, the Taylor X that you mentioned, significantly big cohort, nevertheless, validation and reproducibility of...

How do you think? So now, of course, they're going to continue to order Oncotype DX and maybe with stromal T cells or TILs, you can, cytotoxic TILs, you can...

you can add a little bit of information, another dimension for the immune access, like you were saying.

So you might have a mutation present in the DNA, but RNA tells you whether it's active or not.

Gene expression tests like Oncotype DX fall into this category.

Then you have protein biomarkers, the actual functional output.

HER2 is one, of course.