Caris Life Sciences Submits Application to New York State Department of Health for Caris Assure Blood‑Based Testing Authorization

Rhea-AI Summary

Caris Life Sciences (NASDAQ: CAI) submitted an application to the New York State Department of Health CLEP/Wadsworth Center to seek authorization to perform Caris Assure blood-based molecular profiling on specimens from New York State patients.

Caris Assure uses circulating nucleic acids sequencing to analyze the whole exome and whole transcriptome of 22,000 genes, reporting tumor alterations, clonal hematopoiesis, inherited variants, pharmacogenomics, MSI and TMB. Authorization is pending; Caris will only test New York specimens if CLEP approval is granted.

AI-generated analysis. Not financial advice.

Positive

• Submitted CLEP application to NYSDOH Wadsworth Center
• Caris Assure analyzes 22,000 genes (whole exome and transcriptome)
• CAP-accredited, CLIA-certified laboratory operations

Negative

• No current authorization for New York blood-based specimens
• Availability contingent on CLEP review and receipt of authorization

News Market Reaction – CAI

-1.30%

33 alerts

-1.30% News Effect

-13.4% Trough in 3 hr 18 min

-$74M Valuation Impact

$5.61B Market Cap

0.6x Rel. Volume

On the day this news was published, CAI declined 1.30%, reflecting a mild negative market reaction. Argus tracked a trough of -13.4% from its starting point during tracking. Our momentum scanner triggered 33 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $74M from the company's valuation, bringing the market cap to $5.61B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Genes analyzed: 22,000 genes Q1 2026 revenue: $216.2 million Revenue growth: 79% +5 more

8 metrics

Genes analyzed 22,000 genes Caris Assure whole exome and transcriptome coverage

Q1 2026 revenue $216.2 million Total revenue, up 79% year-over-year

Revenue growth 79% Year-over-year increase in total revenue Q1 2026

Molecular profiling revenue $210.8 million Q1 2026 molecular profiling services, up 85%

Clinical cases 52,800 cases Q1 2026 clinical therapy selection volume

Gross margin 65% Q1 2026 gross margin, improved from 47%

Operating cash flow $32.9 million Q1 2026 operating cash flow

2026 revenue guidance $1.0–$1.02 billion Reaffirmed 2026 revenue outlook implying 23%–26% growth

Market Reality Check

Price: $15.55 Vol: Volume 2,823,918 is 1.55x...

high vol

$15.55 Last Close

Volume Volume 2,823,918 is 1.55x the 20-day average of 1,826,998, indicating elevated trading interest pre-announcement. high

Technical Shares at $19.87 are trading below the 200-day MA of $26.32 and 64.52% under the 52-week high.

Peers on Argus

CAI gained 3.71% while peers were mixed: MRNA fell 6.09%, ROIV 1.94%, HALO 1.11%...

1 Up

CAI gained 3.71% while peers were mixed: MRNA fell 6.09%, ROIV 1.94%, HALO 1.11%, with only modest moves in MDGL and VRNA. Momentum scans show just one peer (MRNA) with upside activity, suggesting CAI’s move was stock-specific rather than a broad biotechnology or medical laboratories rotation.

Historical Context

5 past events · Latest: May 05 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
May 05	AI test launch	Positive	+1.4%	Launch of Caris MI Clarity AI test for breast cancer recurrence prediction.
May 04	Reimbursement milestone	Positive	+1.2%	MolDX approval for Caris ChromoSeq genomic profiling in myeloid malignancies.
Apr 29	AI study validation	Positive	-3.6%	Peer-reviewed validation of AI signature for temozolomide benefit in GBM.
Apr 24	Conference presentations	Neutral	+2.1%	Upcoming presentations at major healthcare investor conferences.
Apr 20	Earnings date notice	Neutral	+0.4%	Announcement of timetable to report Q1 2026 financial results.

Pattern Detected

Recent company-specific announcements, especially new product launches and reimbursement wins, have typically coincided with modest positive price moves, though one major AI-study update saw a negative reaction, indicating occasional divergence between scientific milestones and short-term trading.

Recent Company History

Over the past few weeks, CAI reported several milestones, including AI-driven diagnostics like Caris MI Clarity on May 5, 2026 and MolDX approval for Caris ChromoSeq on May 4, 2026, both followed by small gains of 1.39% and 1.19%. An AI signature study in glioblastoma on April 29, 2026 saw a -3.63% reaction despite positive validation. Investor events and an earnings-date announcement in late April had mild positive impacts. Today’s New York CLEP submission fits a pattern of incremental expansion of the testing and AI-enabled diagnostics franchise.

Market Pulse Summary

This announcement details CAI’s submission to New York’s CLEP program to authorize Caris Assure, a b...

Analysis

This announcement details CAI’s submission to New York’s CLEP program to authorize Caris Assure, a blood-based molecular profiling test analyzing 22,000 genes, for specimens from New York State. It underscores the company’s focus on regulatory compliance and geographic expansion of its precision oncology platform. In context of recent strong Q1 2026 results, including revenue of $216.2 million and a 65% gross margin, investors may monitor the CLEP review outcome, adoption of Caris Assure where already authorized, and any further updates on diagnostic access initiatives.

Key Terms

circulating nucleic acids sequencing, whole transcriptome, clonal hematopoiesis, pharmacogenomic, +3 more

7 terms

circulating nucleic acids sequencing medical

"Caris Assure uses circulating nucleic acids sequencing (cNAS) to analyze the whole exome"

Sequencing of circulating nucleic acids is the process of reading the short fragments of DNA and RNA that freely circulate in the bloodstream to identify genetic changes linked to disease. Think of it like piecing together sentences from shredded pages to spot a story: it enables noninvasive tests for cancer, fetal health, and organ problems, which can drive product demand, recurring testing revenue, and regulatory and reimbursement considerations for investors.

whole transcriptome medical

"the whole exome (DNA) and whole transcriptome (RNA) of 22,000 genes"

The whole transcriptome is the complete set of RNA messages a cell, tissue or organism is producing at a given moment — essentially a snapshot of which genes are turned on and how actively they are sending instructions. For investors, this matters because transcriptome data can reveal disease mechanisms, potential drug targets, biomarkers and patient subgroups, helping assess a biotech’s research progress, clinical strategy and likelihood of commercial success, much like reading a company’s live operations dashboard.

clonal hematopoiesis medical

"This comprehensive test identifies tumor alterations, clonal hematopoiesis (CH) and inherited variants"

Clonal hematopoiesis is a common, age‑related condition in which certain blood stem cells acquire DNA changes and produce a larger share of circulating blood cells, like a few trees in a forest growing taller than the rest. It matters to investors because those altered blood cell clones are linked to higher risk of blood cancers and heart disease, can skew blood‑based tests, and influence drug safety and the market for diagnostics and therapies.

pharmacogenomic medical

"inherited variants, pharmacogenomic alterations, microsatellite instability (MSI) and tumor"

Pharmacogenomic describes how a person’s genetic makeup influences their response to medicines; it’s the study and application of genetic information to predict who will benefit, who will need a different dose, or who might suffer side effects. For investors, pharmacogenomics matters because it can shrink the risk of drug failure, enable targeted therapies and companion tests, and help companies reach the right patients faster—like tailoring a recipe to individual tastes to improve the outcome.

microsatellite instability medical

"inherited variants, pharmacogenomic alterations, microsatellite instability (MSI) and tumor"

Microsatellite instability is a feature of some tumors where short, repeating bits of DNA become error-prone because the cell’s usual “spell-check” for copying DNA is broken; imagine a document with repeated words that suddenly gain many typos. It matters to investors because it serves as a diagnostic marker and a predictor of which patients may respond to certain cancer drugs and tests, influencing drug trial design, approval chances, and demand for companion diagnostics and targeted therapies.

tumor mutational burden medical

"pharmacogenomic alterations, microsatellite instability (MSI) and tumor mutational burden (TMB)"

Tumor mutational burden is a measure of how many genetic changes a cancer cell carries, often expressed as the number of mutations per length of DNA. Think of it like counting typos in a book: more typos can make the abnormal cells stand out to the immune system, and cancers with higher counts sometimes respond better to certain immunotherapies. For investors, TMB can affect how well drugs perform in trials, the need for companion diagnostic tests, and the commercial potential of cancer therapies.

laboratory-developed tests regulatory

"CLEP conducts comprehensive reviews of laboratory permits and laboratory-developed tests"

Laboratory-developed tests are medical tests that a single clinical laboratory designs, builds and runs internally rather than buying from outside manufacturers. Think of them as an in-house recipe a lab creates to detect a disease or measure a biomarker; they matter to investors because they can drive revenue, offer faster product development and carry distinct regulatory and reimbursement risks that affect a healthcare company's financial outlook.

AI-generated analysis. Not financial advice.

IRVING, Texas, May 8, 2026 /PRNewswire/ -- Caris Life Sciences® (NASDAQ: CAI), a leading patient-centric next-generation AI TechBio company and precision medicine pioneer, today announced that it has submitted an application to the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP), administered through the Wadsworth Center, seeking authorization to perform Caris Assure®, its blood‑based molecular profiling test, on specimens originating from New York State.

Caris Assure is a blood‑based molecular profiling test designed to support comprehensive biomarker analysis using a minimally invasive blood sample. Caris Assure uses circulating nucleic acids sequencing (cNAS) to analyze the whole exome (DNA) and whole transcriptome (RNA) of 22,000 genes. This comprehensive test identifies tumor alterations, clonal hematopoiesis (CH) and inherited variants, pharmacogenomic alterations, microsatellite instability (MSI) and tumor mutational burden (TMB).

The submission initiates the formal review process required by New York State for clinical laboratories seeking to perform testing on specimens collected from New York patients. Through the Wadsworth Center, CLEP conducts comprehensive reviews of laboratory permits and laboratory-developed tests to evaluate analytical validation, quality systems, personnel qualifications and compliance with applicable state regulations.

"Caris is committed to meeting the highest standards for laboratory quality, validation and regulatory compliance," said David Spetzler, MS, PhD, MBA, President of Caris Life Sciences. "This submission of Caris Assure for review through the New York State Department of Health's Wadsworth Center reflects our disciplined approach to expanding access to our technologies in a manner that demonstrates the rigor, responsibility and focus on the patient that define Caris Life Sciences and guide our work in the markets we serve."

At this time, no determination has been made by NYSDOH, and Caris Assure is not authorized for use on blood-based specimens originating from New York State unless and until CLEP authorization is granted.

Caris operates a CAP-accredited, CLIA‑certified clinical laboratory and performs testing in jurisdictions where it is authorized to do so, in accordance with all applicable federal, state, and local regulations. Any future availability of Caris Assure in New York State will be contingent upon completion of the CLEP review process administered by the Wadsworth Center and receipt of the appropriate authorization.

About Caris Life Sciences
Caris Life Sciences® (Caris) is a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer actively developing and commercializing innovative solutions to transform healthcare. Through comprehensive molecular profiling (Whole Genome, Whole Exome and Whole Transcriptome Sequencing), advanced AI and machine learning, Caris has created the large-scale, multimodal clinico-genomic database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of next-generation sequencing, AI and machine learning technologies and high-performance computing provides a differentiated platform for developing the latest generation of advanced precision medicine diagnostic solutions for early detection, diagnosis, monitoring, therapy selection and drug development.

Caris was founded with a vision to realize the potential of precision medicine to improve the human condition. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S. and other international markets.

Forward Looking Statements

This press release contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding our business, solutions, plans, objectives, goals, industry trends, financial outlook and guidance. In some cases forward-looking statements can be identified by words such as "may," "will," "should," "would," "expect," "plan," "anticipate," "could," "intend," "target," "project," "potential," "contemplate," "believe," "estimate," "predict," or "continue" or similar expressions.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in these forward-looking statements are reasonable based on information currently available to us, we cannot guarantee that the future results, discoveries, levels of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. Forward-looking statements involve known and unknown risks and uncertainties, some of which are beyond our control. Risks and uncertainties that could cause our actual results to differ materially from those indicated or implied by the forward-looking statements in this press release include, among other things: our future financial performance, results of operations or other operational results or metrics; development, analytical and clinical validation, timing and performance of future solutions by us and our competitors; commercial market acceptance for our solutions, including acceptance of preventive as well as diagnostic testing paradigms, and our ability to meet resulting demand; the rapidly evolving competitive environment in which we operate; third-party payer reimbursement and coverage decisions related to our solutions; risks related to data management, storage, and processing capabilities and our ability to integrate and deploy artificial intelligence and advanced data analytics technologies; our ability to protect and enhance our intellectual property; regulatory requirements, decisions or approvals (including the timing and conditions thereof) related to our solutions, including our application for New York State Department of Health approval for Caris Assure; reliance on third-party suppliers; risks related to data security, patient privacy, and compliance with healthcare data protection regulations as well as potential cybersecurity threats to our data platforms; our compliance with laws and regulations; the outcome of government investigations and litigation; risks related to our indebtedness; and our ability to hire and retain key personnel as well as risks, uncertainties; and other factors described in the section titled "Risk Factors" and elsewhere in our Annual Report on Form 10-K filed on March 3, 2026, and in our other filings we make with the SEC from time to time. We undertake no obligation to update any forward-looking statements to reflect changes in events, circumstances or our beliefs after the date of this press release, except as required by law.

Caris Life Sciences Media:
Corporate Communications
CorpComm@CarisLS.com
214.294.5606 

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SOURCE Caris Life Sciences

FAQ

What did Caris Life Sciences (CAI) file with the New York State Department of Health on May 8, 2026?

They filed an application to CLEP/Wadsworth Center seeking authorization to perform Caris Assure blood-based testing on New York specimens. According to Caris, the submission begins the formal review of analytical validation, quality systems and personnel qualifications.

What does Caris Assure blood test analyze for patients (CAI)?

Caris Assure analyzes the whole exome (DNA) and whole transcriptome (RNA) across 22,000 genes. According to Caris, it reports tumor alterations, clonal hematopoiesis, inherited variants, pharmacogenomics, MSI and tumor mutational burden.

Is Caris Assure authorized for use on New York blood specimens now (CAI)?

No, Caris Assure is not authorized for New York blood specimens at this time. According to Caris, any New York availability requires completion of CLEP review and receipt of the appropriate Wadsworth Center authorization.

Where will Caris perform testing if authorized to serve New York (CAI)?

Caris performs testing in CAP-accredited, CLIA-certified clinical laboratories in jurisdictions where authorized. According to Caris, any New York testing would follow state and federal regulations and be contingent on CLEP approval.

What does the CLEP/Wadsworth Center review examine for Caris Assure (CAI)?

CLEP evaluates analytical validation, quality systems, personnel qualifications and regulatory compliance for laboratory-developed tests. According to Caris, the review is the formal process required before testing New York-derived specimens can be performed.