As cash-rich molecular diagnostics companies scale volume and expand menu breadth, there could be an "acqui-hire" shockwave.

These growing companies likely will continue vertically integrating in front (sample prep) and behind (informatics) to gain . . . (1/4)
. . . operating efficiencies on the move up. Or, there could be a weak link in the existing R&D pipeline that needs mending all-of-a-sudden. For example, that extracting bite-size #epigenetic signal from blood would be central to earlier #cancer detection . . . (2/4)
. . . maybe wasn't as obvious five years ago. There seems to be a ton of awesome IP/university spinouts that've gone on to become private companies and/or patents. Along with this, a fleet of brilliant scientists/impassioned people who . . . (3/4)
. . . may have more opportunities to join ranks with like-minded researchers in R&D divisions of high-growth MolDx firms. (4/4)

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More from @sbarnettARK

18 Feb
Anyone have any opinions on how self-insured employers consider innovative healthcare offerings to pass on to their employees?

As I understand it, by shouldering the financial risk, self-insured employers can curate a list of more relevant benefits ... (1/10)
... thereby avoiding paying out lofty insurance premiums for services that its employees don't use or want. There seems to be a long list of intangible benefits having to do with talent acquisition and retention, but I'd like to understand the cost equations more fully. (2/10)
In the context of multi-cancer screening, I'm skeptical that it could be cost-saving for small or medium-sized employers (<500 employees). Assuming a representative sample of the population, there are simply too few cancers and too many false positives w/ expensive ... (3/10)
Read 11 tweets
17 Feb
@TerraPharma1 @hiddensmallcaps Apologies for the incoming Tweet storm . . .
@TerraPharma1 @hiddensmallcaps Here are some of my thoughts on the Personalis <> Natera tie-up. This is mostly a tech-focused breakdown, so not a recommendation to buy, sell, or hold any security: (bit.do/eyRo8)

First, a bit of background on the details and opinions scattered throughout . . .
@TerraPharma1 @hiddensmallcaps Historically, Personalis has focused entirely on serving the biopharma market. These customers aren't as price-sensitive and they have an insatiable appetite for novel discoveries. In our view, Personalis' NeXT platform is a great biopharma product-market fit. Why? . . .
Read 17 tweets
16 Feb
Interesting that Exact acquired Ashion (private) ostensibly to bring tumor-normal profiling onto the platform. This comes after they got exclusive rights to the TARDIS platform for MRD testing. Both Ashion and TARDIS come out of @TGen, so likely a smoother integration.
Here's the original TARDIS paper: tgen.org/news/2019/augu…

Seems to be another form of error-corrected sequencing, which is useful for liquid biopsy applications where tumor fraction (amount of cancer in body) is very low, so this reads through to mutation-based early ...
... detection assays (CancerSEEK) as well as for MRD, where tumor burden is low, but more emphasis on dynamics of the tumor (treatment resistance, clonal evolution, etc) in addition to just quantification of the tumor (ctDNA % up or down).
Read 6 tweets
13 Jan
I've gotten a few questions about how the FDA regulates medical devices, chemical reagents, and diagnostic equipment.

Quick Thread 👇
First, understand there are two main regulatory pathways for diagnostic testing:

1. In-Vitro Diagnostic (IVD)
2. Laboratory Developed Test (LDT)

An IVD is an FDA-cleared diagnostic test sold as a self-contained kit.

thejournalofprecisionmedicine.com/wp-content/upl…
Companies wishing to sell IVDs must seek pre-market approval (PMA) from the FDA, which can take roughly 200 days. As I understand it, IVD's must be run on FDA-cleared diagnostic equipment, such as the NextSeq 550Dx, which is FDA-cleared and CE-marked (for Europe).
Read 10 tweets
12 Jan
JPM Healthcare Daily Roundup #JPM2021

The first day of the conference hasn't disappointed, especially if you're a fan of talking cubes. What is this mysterious object and what sorcery is inside?

See disclosures at the end.
The Tempus One, meant to be carried in a doctor's coat or sat at the bedside, is a physical manifestation of @TempusLabs' genomic and phenotypic data-lake. Oncologists can ask One all sorts of questions regarding their patients, though I'm unsure if it'll (...)
(...) just reflex you to a computer after a sufficiently difficult question. I'm sure we'll learn more soon. Has this sort of form-factor been tried before?

I'm just hoping it has adjustable humor/honesty settings like TARS from Interstellar.

Moving right along.
Read 15 tweets
10 Jan
Tomorrow kicks off the JP Morgan Healthcare Conference, one of the most information-dense and exciting weeks for biotechnology.
#JPM2021

Though I’ll miss annual lab tours, I’m excited not to have my shoes destroyed amidst all the shoulder-to-shoulder crowds.
Unlike last year, I’m going to try to give a daily news recap once the US trading session closes (inspired by @aurmanARK). My hope is to aggregate input from folks who can offer alternative takes.
We’ve got our #mARKetUpdate webcast on Tuesday, where I’ll be talking more about my recent blog on earlier #cancer detection as well as plans for including community feedback in the forthcoming white paper.

ark-invest.com/articles/analy…
Read 6 tweets

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