Replies to post #243237 on Biotech Values

[DewDiligence]

FDA approves NVTA’s liquid-biopsy cancer diagnostic:

https://www.fda.gov/news-events/press-announcements/fda-grants-first-marketing-authorization-dna-test-assess-predisposition-dozens-cancer-types

…the FDA is establishing special controls that define the requirements related to labeling and performance testing. For example, accuracy for reporting of substitutions, insertions/deletions and copy number variants must be >=99.0% for positive agreement and >=99.9% for negative agreement with a validated orthogonal method.

The FDA considers the Invitae Common Hereditary Cancers Panel a de novo “device,” which enables subsequent diagnostics with substantially equivalent diagnostic performance to be approved under the 510(k) regulatory pathway.

[DewDiligence]

PACB—(-44%)—pre-announces flat 1Q24 revenue:

https://www.prnewswire.com/news-releases/pacbio-announces-preliminary-first-quarter-2024-revenue-and-updates-2024-revenue-guidance-302117738.html

Preliminary [1Q24] revenue of $38.8 million, roughly flat compared with $38.9 million in the prior-year period.

I don’t follow the company closely, so I’m not sure if the revenue flatlining is company-specific or sector-specific.