cat

Cue (bourgeois COVID rapid tests) enshittified btw and now it's test cartridges can't even make it to the 9 month mark they're supposedly gauranteed for

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cue-health-inc-675673-05092024

#warning #covid tests #cue

iliana @iliana5/20/2024, 6:08 AM

what happened to cue health?

i just spent way too long reading press releases and EDGAR filings and... yeah, definitely enshittification on paper, but apparently the writing's been on the wall for a couple of years now.

2010: Cue Health is founded by Ayub Khattak (who serves as CEO) and Clint Sever as a venture-backed company. The company appears to do... something? for about eight years. In 2016 they announced a vague collaboration with Johnson & Johnson for HIV testing.
2018: Cue announces their $45mm Series B including Tarsadia Investments (more on them later), and a $30mm US HHS BARDA contract. These press releases are the first mention of the "Cue Health Monitoring System", listed as their first product; the HHS contract centers around the development of disposable test cartridges for detecting Influenza A and B.
2020: Cue has 99 employees.
H1 2020: Cue gets another $13mm from HHS BARDA for retooling their system to work for detecting COVID-19 at point-of-care, and raises a $100mm Series C a few months later. In June's Series C announcement, they wrote "Cue is also completing the validation needed for FDA submission of its portable system for at-home influenza A and B testing", which has never seen the light of day.
H2 2020: Cue is awarded $481mm by the US DOD and HHS.
Mar 2021: FDA issues its first Emergency Use Authorization for their at-home COVID-19 test.
May 2021: Cue raises another $235mm.
Sep 2021: Cue announces an IPO.
Dec 2021: Cue has 1,585 employees.
Feb 2022: Cue airs a Super Bowl ad.
Jun 2022: Cue establishes a $100mm revolving credit facility.
Jan 2023: Cue lays off 388 employees.
Mar 2023: FDA issues an EUA for Cue's mpox test, only available at point-of-care.
Apr 2023: Cue lays off 326 employees.
Jun 2023: Nasdaq sends a delisitng notice to Cue for failing to maintain a share price of more than $1.00.
Aug 2023: Tarsadia Investments, a top-10 stockholder, sends a public letter to Cue noting that the share price has fallen 97% since its IPO, and vaguely demands immediate changes (probably more layoffs).
Sep 2023: Cue's Board adopts a shareholder rights plan (more affectionately known as a poison pill); it's unclear why.
Oct/Nov 2023: FDA performs an inspection of Cue's facilities.
Jan 2024: Cue lays off 245 employees.
Feb 2024: Cue enters into an agreement with Tarsadia, adding a Tarsadia managing director, Rishi Reddy, to the board.
Mar 2024: Ayub Khattak steps down as CEO, and remains on the board. Clint Sever is appointed as CEO.
Apr 2024: Cue announces a "review of strategic alternatives", including a potential sale of the company, and announces the FDA has denied OTC approval of their RSV test.
May 1: Cue lays off 230 employees.
May 9: FDA sends its Warning Letter to Cue Health, alleging that in Oct 2023, Cue modified its COVID-19 test from the EUA-approved version without approval in a manner that may reduce the shelf-life of a test below the only 9 months claimed on the product labeling. Cue pauses sales.
May 12: Former CEO Ayub Khattak resigns from the board.
May 14: At the annual company meeting, the chairman of the board immediately adjourned the meeting and postponed all business to a future time.
May 15: Rishi Reddy (Tarsadia Investments) resigns from the board.

I'm not sure how you receive half a billion dollars in government funding and run a business into the ground this quickly, but if I need it to happen again, I know who to call.

Obviously the general not-giving-a-shit-about-COVID the US has pulled over the last few years has affected Cue's business but I've always found it pretty alarming that their expensive bougie test reader never got more than a COVID-19 test OTC. I also didn't realize that their tests only had a 9-month shelf life, I just thought they were bad at supply and demand. (I recently switched to Metrix, which just received FDA approval to extend the shelf life of their tests to 18 months.)

At their prices I guess it's not surprising the FDA had trouble determining the benefits outweighed the risks.

@catball shared with:

#rebug

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in reply to @NireBryce's post:

cat @catball5/14/2024, 4:36 AM

god, lmao, ridiculous. they charge like a hundred bucks a pop for those things. i guess you can just make whatever garbage once you have a contract to make it for the DoD

Nire Bryce @NireBryce5/14/2024, 5:16 AM

i think it was down to like 30 bucks a test but yeah.

but also like, i think thats part of it right? COVID restrictions slacken and all your 'we will make it less expensive as time goes on as initial costs are subsidized by early adopters' evaporates but you IPO'd in 2021 and now you're just fucked, so you cut costs and pull a boeing

cat @catball5/14/2024, 5:35 AM

ough yeah that's a good point. I wish we could just have like. reliable medical supplies and medical care. im dreaming big here in capitalism world :eggbug-sob:

Ada @songdragon6/11/2024, 6:28 PM

I was paying $50 per test, I think

Ada @songdragon5/14/2024, 6:26 AM

As a bourgeoisie who shelled out for these, I’m pissed

Nire Bryce @NireBryce5/14/2024, 6:31 AM

I mean more seller than buyer fwiw, since the other tests are like, a test strip wrapped in several layers of literal trash

Maya @Mayabotics5/14/2024, 7:09 AM

Wow, making those changes without notifying the FDA was them just begging to have the book thrown at them.

I could see how it happened too. Management was probably leaning on engineering to fix an edge case that was causing a greater than expected number of QC batch rejections, while also leaning heavily on QC/QA to pass more batches because they probably cut the unit price below what would be profitable with their current reject rate.

And management probably wanted it all done yesterday too, so nobody finished the necessary FDA paperwork before they started shipping the changed devices to customers.

Medical devices companies are scummy. I have a list somewhere of the phrases that adorned banners and posters at one of the places I contracted at, and they were all things like "Don't put it in writing or an email until you talk to a manager."

Engineers at that place considered it inevitable that they would someday have to testify in court against their employer.

in reply to @iliana's post:

@sapphire5/20/2024, 7:15 AM

need me a grift like this

Maya @Mayabotics5/20/2024, 1:15 PM

Since people are probably interested enough to dig into it, here are the Federal Procurement Contracts that Cue Health received most recently. (Might be easier to pull information out on the newer site.)

The two HHS contracts(HHS BARDA IDV Definite Contract Award), a few other decent sized contracts, plus DLA only exercised a very modest but reoccurring purchase under the DoD IDIQ (Indefinite Delivery/Indefinite Quantity).

It looks like the older HHS BARDA IDV and older DoD IDV was initially awarded to a different entity. The recipient page. FPDS listed awards

EDIT: Originally, commented about HHS contract outlays here, but it turns out I can't math right, though I'm finding the outlays are being reported a bit odd, and I don't have any more time to investigate what's going on at the moment.

The DoD IDV has something weird is going on there with outlays.

Because of the two separate entities involved, it looks like USA Spending is a bit screwed up when it comes to linking awards and outlays up correctly.

If people want to dig further, IDs to look for:

Currently Active CUE HEALTH INC
Expired CUE INC

If anyone is curious to what an IDV is.