Quest Diagnostics Receives New York State Approval for Haystack MRD®, Broadening Patient Access to ctDNA Minimal Residual Disease Testing

Quest Diagnostics (NYSE:DGX) received New York State Department of Health CLEP approval for its Haystack MRD ctDNA liquid biopsy test to identify residual or recurring disease in a range of solid tumor cancers.

Rhea-AI Summary

Quest Diagnostics (NYSE:DGX) received New York State Department of Health CLEP approval for its Haystack MRD ctDNA liquid biopsy test to identify residual or recurring disease in a range of solid tumor cancers.

With this authorization, Haystack MRD is now available for patient testing in all 50 U.S. states, supported by published clinical data showing it identified clinical complete response at a median of 1.4 months versus over 6 months with imaging.

Positive

• NYSDOH CLEP approval for Haystack MRD ctDNA liquid biopsy test
• Authorization enables Haystack MRD patient testing in all 50 U.S. states
• Test targets residual or recurring disease in a range of solid tumor cancers
• Clinical utility supported by NEJM May 2025 study in dMMR tumors
• Median response detection at 1.4 months vs >6 months for imaging in study

Negative

• None.

Argus Jun 24 session

+3.01% close to close Open Argus

Details

News Market Reaction – DGX

On Jun 24, the day this news came out, DGX closed 3.01% above the previous close.

Data tracked by StockTitan Argus for the Jun 24 session.

Key Figures

Median ctDNA response time: 1.4 months Imaging response time: more than 6 months U.S. coverage: 50 U.S. states +3 more

Median ctDNA response time

1.4 months

Time for Haystack MRD to identify clinical complete response in landmark dMMR study

Imaging response time

more than 6 months

Time for imaging methods to identify clinical complete response in same study

U.S. coverage

50 U.S. states

Haystack MRD authorized for patient testing nationwide after New York approval

Pre-approval availability

49 states and the District of Columbia

Haystack MRD ordering footprint before New York CLEP approval

Initial availability timing

late 2024

When Haystack MRD became available for clinician ordering in most jurisdictions

Study publication date

May 2025

Publication of landmark dMMR solid tumor study using Haystack MRD in NEJM

Historical Context

5 past events · Latest: Jun 18

5 events

1. Jun 18

   Clinical study news

   24h Move

   -1.4%

   Publication of nationwide study on multidrug-resistant UTI-causing bacteria with Quest involvement.

2. Jun 17

   Earnings date notice

   24h Move

   -1.6%

   Announcement of scheduled release and call for Q2 2026 financial results.

3. Jun 16

   ESG report release

   24h Move

   -0.6%

   2025 Corporate Responsibility Report detailing progress in access, workforce, governance, sustainability.

4. May 19

   Dividend declaration

   24h Move

   +1.3%

   Board declaration of a $0.86 per share quarterly cash dividend for shareholders.

5. Apr 27

   Debt offering

   24h Move

   -0.8%

   Pricing of $500M 5.000% senior notes due 2036 under existing shelf registration.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

circulating tumor dna, ctdna, liquid biopsy, minimal residual disease, +2 more

6 terms

circulating tumor dna medical

"a circulating tumor DNA (ctDNA) liquid biopsy test, for use in identifying residual"

Fragments of DNA shed by cancer cells into the bloodstream that act like tiny fingerprints of a tumor; they can be detected with a blood test rather than a biopsy. Investors care because circulating tumor DNA (ctDNA) enables faster, lower-cost ways to detect disease, track treatment response, identify emerging resistance and enroll patients in trials—factors that can materially affect the commercial prospects of diagnostics and therapeutics.

ctdna medical

"In that study, ctDNA testing, using Haystack MRD, was found to be a"

Circulating tumor DNA (ctDNA) is tiny fragments of genetic material shed by cancer cells into the bloodstream, like breadcrumbs that can reveal a tumor’s presence and genetic makeup without needing a biopsy. For investors, ctDNA matters because tests and technologies that detect and analyze these fragments can speed diagnosis, track treatment response, and signal relapse, creating commercial opportunities in diagnostics, personalized therapies, and monitoring services.

liquid biopsy medical

"a circulating tumor DNA (ctDNA) liquid biopsy test, for use in identifying"

A liquid biopsy is a laboratory test that looks for tiny pieces of tumor or disease-related material — such as DNA, proteins, or cells — circulating in blood or other body fluids, allowing detection and monitoring without a surgical tissue sample. For investors, it matters because these tests can speed diagnosis, guide treatment choices, enable easier repeat testing, and create recurring revenue streams if adopted widely, affecting a medical company's growth and regulatory risk profile.

minimal residual disease medical

"access to ctDNA Minimal Residual Disease Testing"

Minimal residual disease (MRD) is the tiny number of cancer cells that remain in the body after treatment, often too few to show up on standard scans but detectable with very sensitive tests. For investors, MRD is important because it predicts the risk of relapse and can determine whether a therapy is seen as effective, influences regulatory and reimbursement decisions, and affects the size and timing of a drug’s market opportunity—like spotting the last weeds that can make a garden regrow if not removed.

clinical complete response medical

"a "reliable liquid biopsy surrogate" that identified clinical complete response at a median"

Clinical complete response describes when medical exams, scans and tests detect no remaining signs of a disease after treatment, even if microscopic disease cannot be absolutely ruled out. For investors, it signals that a therapy is working well in patients, which can boost a drug’s commercial prospects, speed regulatory decisions, and influence future trial design; think of it as a storm clearing from the radar, suggesting meaningful recovery.

mismatch repair–deficient medical

"non-operative management of patients with locally advanced mismatch repair–deficient (dMMR) solid tumors"

Mismatch repair–deficient describes cells that have lost the normal ability to fix simple errors that occur when DNA is copied, like a spell-checker that’s turned off so typos accumulate. This condition often leads to many mutations and can predict whether certain cancer tests and treatments—especially some immunotherapies and diagnostic tests—are likely to work, making it a key biomarker for drug development, regulatory decisions and market value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Achieving the rigorous laboratory standard broadens access for providers and patients in New York; applies to use of Haystack MRD for patients with solid tumor cancers

SECAUCUS, N.J., June 24, 2026 /PRNewswire/ -- Quest Diagnostics^® (NYSE: DGX), a leading provider of diagnostic information services, today announced that the New York State Department of Health's (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) has approved the company's Haystack MRD^® test, a circulating tumor DNA (ctDNA) liquid biopsy test, for use in identifying residual or recurring disease in patients with a range of solid tumor cancers.

New York maintains a highly rigorous clinical laboratory oversight program, requiring formal technical review and approval of laboratory developed tests before they may be offered to patients in the state. With this approval, Haystack MRD is now authorized for patient testing in all 50 U.S. states. The test was developed under CLIA regulations and has been available for clinician ordering since late 2024 in 49 states and the District of Columbia.

"This approval represents the culmination of our many years of hard work and commitment to delivering a highly accurate test that can meaningfully improve patient care," said Dan Edelstein, Vice President and General Manager for Haystack Oncology, a Quest Diagnostics company. "Haystack MRD was designed to give oncologists the confidence to detect residual disease earlier, catch recurrence before it becomes clinically apparent, and help identify response to treatment. New York's approval is another proof point for Haystack MRD's quality and technical sophistication, and we look forward to extending access to this important innovation for clinicians and patients in the state."

In addition, Haystack MRD's clinical utility has been demonstrated in rigorous investigational settings, including the landmark study of non-operative management of patients with locally advanced mismatch repair–deficient (dMMR) solid tumors, which was led by Dr. Andrea Cercek and colleagues at Memorial Sloan Kettering Cancer Center and published in The New England Journal of Medicine in May 2025. In that study, ctDNA testing, using Haystack MRD, was found to be a "reliable liquid biopsy surrogate" that identified clinical complete response at a median of 1.4 months, compared to more than 6 months using imaging methods.

"In our study of non-operative management for dMMR solid tumors, the use of MRD testing provided additional molecular information that complemented traditional assessments such as imaging and endoscopy," said Dr. Cercek, Medical Oncologist, Memorial Sloan Kettering Cancer Center. "For patients who may avoid surgery, having multiple tools to evaluate treatment response and monitor for recurrence is important. These findings highlight the crucial role of MRD testing in informing patient management and underscore the need for continued study as these approaches are integrated into clinical practice."

About Haystack Oncology
Haystack Oncology represents the culmination of over 20 years of collaboration to advance technical and clinical development in liquid biopsy technologies by cancer genomics pioneers at Johns Hopkins School of Medicine. The company, a wholly owned subsidiary of Quest Diagnostics, developed Haystack MRD, a tumor-informed, next-generation MRD test that detects ultralow levels of ctDNA to uncover residual or recurrent disease with exceptional sensitivity and specificity. Haystack Oncology works with biopharmaceutical companies to accelerate and inform clinical development programs and advance important therapeutics to global markets, from early phase clinical development to companion diagnostics. Haystack MRD was developed and validated in a CLIA-certified laboratory and is available for commercial use as a lab-developed test (LDT) by Quest Diagnostics. The FDA granted Haystack MRD Breakthrough Device Designation in 2025 for use in Stage II colorectal cancer. Haystack MRD is also available for clinical trials as an investigational device by Haystack Oncology in laboratories located in Baltimore, Maryland; Hamburg, Germany; and Helsinki, Finland. www.haystackmrd.com

About Quest Diagnostics
Quest Diagnostics works across healthcare to create a healthier world, one life at a time. We connect people, from clinicians to consumers, with laboratory insights that illuminate a path to better health. With a focus on delivering smarter, simpler testing, we help reveal new avenues to identify and treat disease, empower healthy behaviors and improve healthcare management. Quest Diagnostics serves half the physicians and hospitals in the United States and one in three American adults each year, and our nearly 57,000 employees work together to deliver diagnostic insights that inspire actions to transform lives. www.QuestDiagnostics.com

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SOURCE Quest Diagnostics

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Quest Diagnostics (NYSE:DGX) announce about Haystack MRD on June 24, 2026?

Quest Diagnostics announced New York State Department of Health CLEP approval for its Haystack MRD ctDNA liquid biopsy test. According to Quest Diagnostics, this authorization allows use for identifying residual or recurring disease in patients with a range of solid tumor cancers within New York.

How does New York approval affect access to Haystack MRD for Quest Diagnostics (DGX) patients?

New York CLEP approval allows Haystack MRD to be offered to patients in New York state. According to Quest Diagnostics, the test is now authorized for patient testing in all 50 U.S. states, expanding provider and patient access to ctDNA MRD assessment.

What type of cancer patients can benefit from Haystack MRD testing from Quest Diagnostics (DGX)?

Haystack MRD is intended for patients with a range of solid tumor cancers to assess residual or recurring disease. According to Quest Diagnostics, oncologists can use the ctDNA liquid biopsy to help detect residual disease, monitor for recurrence, and evaluate response to treatment.

What clinical data support Quest Diagnostics Haystack MRD test for minimal residual disease?

Haystack MRD’s clinical utility has been evaluated in rigorous investigational settings, including dMMR solid tumor studies. According to Quest Diagnostics, a NEJM May 2025 study found Haystack MRD a “reliable liquid biopsy surrogate,” identifying clinical complete response at a median 1.4 months versus over 6 months with imaging.

How does Haystack MRD from Quest Diagnostics (DGX) compare with imaging in detecting treatment response?

In a study of non-operative management for dMMR solid tumors, Haystack MRD identified clinical complete response earlier than imaging. According to Quest Diagnostics, the ctDNA test showed a median detection time of 1.4 months, compared with more than 6 months using imaging methods.

What role can Haystack MRD play in managing solid tumor patients for Quest Diagnostics clients?

Haystack MRD can provide molecular information on residual disease, recurrence risk, and treatment response in solid tumor patients. According to Quest Diagnostics, it complements imaging and endoscopy, giving oncologists additional tools for evaluating response and monitoring patients who may avoid surgery.