Replies to post #225029 on Biotech Values

[DewDiligence]

Thanks—good info. Yahoo shows “Quarterly Revenue Growth (YoY)” as -1.4%. Is this the correct figure?

[DewDiligence]

EXAS reports early liquid-biopsy data in pancreatic cancer:

https://www.prnewswire.com/news-releases/exact-sciences-advances-pipeline-capabilities-with-mayo-clinic-300853108.html

Lead author and Mayo Clinic gastroenterologist Shounak Majumder, M.D. presented results from the 340-sample, case-control study. A panel of methylated DNA markers in plasma in combination with CA 19-9, achieved a cross-validated sensitivity of 79% in Stage 1, 82% in Stage 2, 94% in Stage 3 and 99% in Stage 4 pancreatic ductal adenocarcinoma (PDAC) with 92% specificity (81-100%). This combination was significantly better than CA 19-9 alone.

…Statistical modeling was used to identify the best algorithm to predict disease status in this sample set. Subsequently, the panel was cross validated by randomly splitting the entire data set into training and testing sets. The fitted model from the training set was used to predict disease status in the test set over multiple iterations. This study used a small number of archival patient blood samples, which could lead to over-fitting to this particular sample set and cause subsequent sensitivity and specificity to decline in a larger, prospective population.

A prospective validation study is currently underway at Mayo Clinic.

EXAS is the manufacturer and vendor of Cologuard, which was developed in conjunction with Mayo.

[DewDiligence]

GRAIL update:

https://www.businesswire.com/news/home/20190531005308/en

[DewDiligence]

FDA approves GH’s liquid-biopsy test to guide treatment for solid tumors generally, and to serve as a companion diagnostic for Tagrisso:

https://www.globenewswire.com/news-release/2020/08/07/2075187/0/en/Guardant-Health-Guardant360-CDx-First-FDA-Approved-Liquid-Biopsy-for-Comprehensive-Tumor-Mutation-Profiling-Across-All-Solid-Cancers.html

Guardant Health, Inc. announces that the U.S. Food and Drug Administration (FDA) has approved Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor).

The Guardant360 CDx is also approved as a companion diagnostic to identify non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with Tagrisso (osimertinib). Guardant360 CDx offers patients and clinicians a simple, faster blood test to help inform personalized treatment options.