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If what Bermondsey is reporting holds true that his contact has said CLIA has been granted then surely its price sensitive news so CIZ would be obligated to release news tomorrow via RNS. It’s not news they can sit on really right?

FDA approval not required as per from Bill Behnke: "We are a lab developed test and do not require FDA acceptance although down the road we may choose to go through the process of FDA."

At this stage CLIA certification is crucial (which seems to be not far off)

The fact that omni has started to advertise that the test is soon to be available indicates that they are confident of CLIA approval soon.

Its all good and well Ciz Bio to be saying "Coming Soon" for the last year or so but when the partner lab starts to advertise it shows that this is nearing launch.

Decided to visit the omni site to see if anything has been updated and weas welcomed by a huge popout (select any page that isnt the homepage and you will be greeted by it):

Introducing New Cancer Detection Testing

OmniHealth Diagnostics is proud to partner with Cizzle Bio to expand access to innovative blood-based cancer detection testing for licensed healthcare providers.

Now featuring:

CIZ1B Lung Cancer Detection

DEX-G2 Gastric Cancer Detection

Below is a link to the page that it takes you to when clicking learn more about CIZ1B

https://www.omnihealthdx.com/cizzle-bio-lung-cancer

Good spot Tedc

Bear in mind the Galleri test is not the only one being trialled or to be trialled within the NHS:

Multi-cancer MODERNISED Blood Test:

A trial led by University Hospital Southampton is evaluating a blood test that looks for early immune responses signalling up to 10 different cancers — and may also help identify the tissue of origin.

https://www.uhs.nhs.uk/whats-new/press-releases/trial-of-new-test-to-spot-the-early-signs-of-10-different-cancers

miONCO-Dx Multi-Cancer Detection Test:

Planned NHS trials (on ~8,000 patients) of a blood test that uses tumour DNA fragments and AI to detect up to 12 common cancers (including lung, prostate, bowel, breast, ovarian, liver)

https://www.nihr.ac.uk/story/nihr-backs-new-blood-test-earlier-cancer-detection

AI-Driven trials for Breast, Lung, Prostate Cancer:

https://www.gov.uk/government/news/world-leading-ai-trial-to-tackle-breast-cancer-launched

https://www.england.nhs.uk/2025/10/nhs-artificial-intelligence-ai-trial-to-diagnose-prostate-cancer-up-to-a-month-faster

https://www.england.nhs.uk/2026/01/nhs-launches-trailblazing-ai-and-robot-pilot-to-spot-lung-cancer-sooner

Overall I think it was a positive RNS:

- Confirmation that CLIA is at completion stages.

- Accreditation expected immediately after submission. (Q2-2026)

- Commercial sales expected immediately. (Hopefully they're not basing this on me hounding omni asking when CIZ1B will be available 😆)

- $1.81m owed by BIO to be received by end of 2026.

Hopefully between now and news of CLIA approval we hear more about progress in the UK.

Hi Bermondsey,

spelling is correct "Yomna Shahid"

https://www.linkedin.com/posts/yomna-shahid-65b201283_what-a-great-start-to-the-year-omnihealth-activity-7415832388871589888-JcKc?utm_source=li_share&utm_content=feedcontent&utm_medium=g_dt_web&utm_campaign=copy

https://www.linkedin.com/in/yomna-shahid-65b201283?trk=public_post_feed-actor-name

For what it is worth after doing some sleuthing I found a month old post on linked in by somebody that works at omni. (Yomna Shahid):

What a great start to the year! 🎉

OmniHealth Diagnostics is officially live and ready for patient testing!

After months of preparation, extensive training, instrument installs (shoutout to Abbott | Diagnostics, Abbott!), troubleshooting—and more troubleshooting—and let’s not forget the coffee ☕—we are finally up and running!

Teamwork and dedication has paid off!

Proud of what we’ve built and excited for what’s ahead as we begin delivering reliable, high-quality diagnostic testing for our patients and providers.

Here’s to growth, innovation, and a strong year ahead! 🚀 🧪 👩🔬

Agree with Tech that the holdup could most likely be due to omni not having its infrastructure set up to support a nationwide rollout.

Not sure why BIO didn't decide to go with a partner that already has the required network/infrastructure in place. Maybe going with Omni was the more cost effective option?

RNS 29/09/25:

"Omni focuses on delivering precise, accurate, and reliable results to support healthcare providers and patients and has an active expansion programme to acquire or partner with other accredited laboratories throughout the USA including New York, California, South Carolina, Tennessee and Florida to enable a nationwide testing capability. "

"BIO and Omni will engage in a progressive marketing campaign, working closely with patient advocacy groups to enable easy patient engagement and so reduce premature cancer deaths and improve survival rates and quality of life for cancer patients."

It would seem that whoever posts on Cizzle's LinkedIn profile does check out this board.

https://www.linkedin.com/posts/cizzle-biotechnology-plc_cizzle-biotech-regulatory-news-live-ciz-activity-7424771873843875841-5jng

The link to the RNS directs to the RNS on this site.

I emailed Omni and they replied "At this time, we do not have a timeline on when this test will be available.".

I assume even if they did know they wouldn't be able to say.

I'd like to think the new website is in anticipation for a lot more eyeballs potentially coming their way.

I added to my modest holding with another 20,000 @ 1.47p shares earlier this week however oddly enough the trade didn't appear on here but did show up on the official LSE site.

I would think you are correct in assuming that Frazer Lang would be privy to more info than us the regular investor seeing as his 2nd CLN RNS was issued 1 minute after the LOI RNS.

Hi Bermondsey.

Not sure if you meant this as a reminderof the delay or mistaken this as new but its old from January 25.

Cizzle Biotechnology Holdings PLC’s Year of Milestones

For Cizzle Biotechnology, this has been a defining year in our mission to transform lung cancer detection through our proprietary CIZ1B biomarker blood test, which has demonstrated 95% sensitivity for early-stage disease.

This year, we delivered several major steps forward:

North American Expansion – Having completed our exclusive licensing agreement with Cizzle Bio Inc. for the USA and Canada, our licensing partners have signed their first contracts with commercial clinical laboratories to launch our biomarker test following CLIA certification, opening the door to one of the world’s largest healthcare markets.

UK Healthcare Engagement – We signed a Letter of Intent with a major UK laboratory provider serving the National Health Service, which may lead to an exclusive UK partnership and co-branded rollout across NHS and private markets in the UK. This underscores our commitment to making early lung cancer detection accessible nationally.

Clinical Validation at Leading Centres – Our selection by the Moffitt Cancer Center in Florida marked a pivotal milestone, the first major clinical evaluation of the CIZ1B biomarker in patients with suspicious lung nodules.

Advancing the Science – We continue to collaborate with the University of York, driving innovation and creating new IP for the CIZ1B biomarker.

Looking Ahead

With scientific innovation, clinical evaluation, and commercial partnerships aligning, 2026 is set to be a transformative year for blood-based lung cancer screening. Using biomarker-driven tests like ours offer a powerful complementary pathway to LDCT scanning helping provide earlier, more accurate detection.

As this awareness month closes, we’re reminded that progress is born from persistence, partnership, and purpose. The breakthroughs emerging today offer hope for tomorrow’s patients, and Cizzle remains committed to leading that change.

https://cizzlebiotechnology.com/reflecting-on-lung-cancer-awareness-month-and-purpose/

Hi All,

So which lab/company do you think Ciz has signed the LOI with?

After feeding chat GPT paragraphs from the RNS and asking it to shortlist potential partners I researched some and feel like Synlab is best suited. They have a vast network in UK and throughout Europe and already has existing services which it provides to NHS.

So who are you predicting this partner to be?

Is anybody aware of Freenome? It looks like they are american based, diagnostics compnay who also aiming to commercialise their early lung cancer detection test. Seems they acquired Oncimmune back in 2023 which provided this platform. They have a study ongoing recruiting 20,000.

https://clinicaltrials.gov/study/NCT06122077?term=proact%20lung&rank=1

For comparison i look at the registry for the moffit trial but shows diagnostic test being used DetermaRX.

https://clinicaltrials.gov/study/NCT05665504?term=CIZ1B&rank=1

Is this the same trial moffit is running in collab with Ciz BIo?

Interestingly freenome recruiting 20K and Moffit only 250? why would this be so small compared to freenome trial? Anyone with a better understanding could kindly explain?

Hopefully a lot of the data used for validation in the US can be used by UKCA to speed things up once the ball gets rolling.