PALM BEACH, Fla., June 27, 2025 (GLOBE NEWSWIRE) -- Today marks a significant milestone for theranos and its diagnostic technology. The theranos system performs automated sample processing and analysis to produce clinical test results. The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) has affirmed that the core technology is not under question.

theranos is now also in communication with the FDA's Center for Drug Evaluation and Research (CDER), following concerns identified during a clinical trial involving a third-party pharmaceutical. The company previously received FDA 510(k) clearance (K143236) for its HSV-1 IgG assay plus the Edison device and is currently submitting additional biomarkers and system data for FDA review.

"I had a great conversation with Dr. Michelle Tarver, Ph.D., at the FDA today," says Ryan ElHosseiny, inventor and CEO of theranos. "Our technology is solid. What we discovered during our cancer Pfizer Drug Study has now led to a broader conversation about pharmaceutical safety, specifically related to the drug Avastin, which has shown serious adverse effects in patients."

According to ElHosseiny, the findings at theranos echo longstanding concerns raised by RFK Jr., Director of the Department of Health and Human Services.

ElHosseiny also says, "There is No FDA approved Total VEGF test or Free VEGF test for detecting and quantifying this cancer marker. There is only RUO (research use only) test kits that labs purchase from commercially available manufacturers like Sigma and R&D Systems/biotechne. Labs then take those kits, do a simple validation and slap an LDT label (lab developed test) on it in which it now becomes regulated by CMS & CLIA and bypasses the FDA regulatory channel. theranos tests are superior and our Total VEGF test will be marked as FDA approved" he added.

"We are here to support MAHA, not just in word but through real action—by pressing for transparency and accountability in the regulatory process. Protecting America's public health is our shared mission," ElHosseiny explains. "Our work highlights critical safety concerns, and we're committed to doing everything in our power to save lives."

theranos points to a precedent set by Siemens Healthineerswhich received FDA 510(k) clearance for its Atellica IM System based on only two assays: Ferritin (K171642) and βHCG (K172322). Those two approvals preceded full clinical rollout for a wide panel of immunoassays, including cancer markers such as PSA Total, PSA Free, CA 19-9, and CA 125.

theranos will now follow the Siemens approval path and mark their cancer markers FDA approved and welcomes the FDA to challenge these tests. "If you challenge me, challenge Siemens, Roche, Beckman, Abbott, Quidel-Ortho and every IVD manufacturer" says ElHosseiny. "Because the Edison 3.0 (TSPU) only has a spectrophotometer and a robot which classifies it under ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE. FDA Product class code: JJE. It is a class 1 device and is FDA 510k exempt as long as we register the device. Siemens Atellica Progesterone is 510k exempt and Siemens sells it as an FDA approved assay. theranos has been transparent from day 1, and if you're going to run into my factory, run into everyone else's factory. We do it the right way." ElHosseiny boldly said.

The tests below will be marked FDA approved.
-VEGF Total (Vascular Endothelial Growth Factor)
-PLGF 1 (Placental Growth Factor)
-VEGFR 2 (Vascular Endothelial Growth Factor Receptor 2)

"All of the FDA 510K approvals can be searched online. This is a big day for theranos," says ElHosseiny. "Our goal is to bring advanced diagnostic technology to the public in a safe, transparent way. People deserve to understand their own health data and to trust that the treatments and therapies they rely on are safe and effective."

In a personal statement, ElHosseiny also said that all he did was reverse engineer the work Elizabeth Holmes accomplished as the inventor, founder and former CEO of theranos.

"Free Elizabeth Holmes, the pioneer behind this mission I've now been privileged to continue," he says. "I've never met or spoken to her, but I studied her work. As a filmmaker and diagnostics expert, I can say that the work done on the Edison device, the hundred plus test validations and the sample collection system material I've reviewed show that this lab was not a fraud. My process was securing the nanotainers, tearing them apart and testing the anticoagulants in the chambers using GC/MS/MS at a lab in Dubai, UAE called Holistic International Testing Services - HiTS. It took me more than four years to completely reverse engineer this company and prove by trial exhibits and the science, that Elizabeth Holmes is innocent. I've opened up every commercial analyzer, run a million tests on various platforms and spent endless days & nights on all of the incredible technologies at theranos."

ElHosseiny has released a new documentary, The Inventors, now streaming on the theranos website.
www.theranoslabs.com 

CONTACT: Media Contact: Ryan ElHosseiny, Ryan@theranoslabs.com