FDA Grants Breakthrough Machine Standing to MRD Take a look at in Colorectal Most cancers

The U.S. Meals and Drug Administration (FDA) has granted breakthrough gadget designation to Quest Diagnostics’ Haystack MRD check, which is used to determine minimal residual disease-positive sufferers with stage 2 colorectal most cancers after curative-intent surgical remedy who could profit from adjuvant, or postsurgical, remedy, the corporate introduced.

A medical laboratory-developed check model of Haystack MRD was launched by Quest in late 2024, the corporate famous within the information launch.

“We’re dedicated to working with the FDA and our analysis companions to validate using Haystack MRD in quite a lot of stable tumors, constructing on this primary designation for an early-stage colorectal most cancers,” stated Dan Edelstein, vp and basic supervisor, Haystack Oncology, within the information launch issued by Quest. “Our purpose is to ship extremely correct, personalised monitoring of remedy response and recurrence to extra sufferers, each in medical care and in pharmaceutical trials, and this Breakthrough Designation brings us nearer to our purpose.”

Minimal residual illness, as outlined by the Nationwide Most cancers Institute, is a time period used to explain a really small variety of most cancers cells that stay within the physique throughout or after remedy.

The Breakthrough Gadgets Program, in keeping with the information launch, applies to sure medical gadgets and device-led mixture merchandise that present for simpler remedy or analysis of life-threatening or irreversibly debilitating illnesses or circumstances, and is meant to supply sufferers and suppliers with well timed entry to medical gadgets.

Haystack MRD, as detailed within the information launch, is a blood check that’s supposed to detect low ranges of circulating tumor DNA, or ctDNA, that are fragments of DNA from tumor most cancers cells within the affected person’s blood stream.

ctDNA Testing Reveals Potential as a Dependable, Much less Invasive Most cancers Instrument

Circulating tumor DNA might doubtlessly provide nice medical utility to sufferers, one knowledgeable defined in a 2024 interview with CURE.

“Relatively than going after a stable tumor and placing a needle in there, you possibly can simply get a tube of blood and get a few of that genetic data (recognizing I am saying some, as a result of you possibly can’t essentially get all) and the opposite benefit is you are able to do serial blood attracts pretty simply in comparison with serial tissue biopsies,” Dr. Ben Ho Park, director of the Vanderbilt-Ingram Most cancers Heart in Nashville, defined within the interview.

“There’s nice potential utility right here,” he continued. “And that’s, can we use liquid biopsies or ctDNA to determine who’s cured or who’s not? And that is been a giant buzz these days, as a result of because the years have passed by, expertise has improved. Our understanding of what we might do with this has improved.”

Earlier this yr, Quest introduced findings of a report which acknowledged that 94% of oncologists stated that ctDNA MRD testing might cut back analysis delays in most cancers recurrence, however they cited hurdles to broad adoption.

Moreover, in a research revealed earlier this yr in The New England Journal of Medication, researchers discovered that ctDNA testing utilizing Haystack MRD was a “dependable liquid biopsy,” in keeping with a information launch from Memorial Sloan Kettering Most cancers Heart in New York.

In response to Quest, Haystack MRD has been utilized in a number of medical trials and analysis research in america, Canada and Australia and by clinicians at extra that 75 most cancers and educational facilities and well being techniques, and is now accessible for medical use as a part of Quest Diagnostics’ oncology testing portfolio. The check can also be accessible for medical trials as an investigational gadget.

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References

1. “FDA Grants Breakthrough Machine Designation for Haystack MRD Circulating Tumor DNA Take a look at from Quest Diagnostics,” by Quest Diagnostics. Information launch; Aug. 25, 2025. https://newsroom.questdiagnostics.com/2025-08-25-FDA-Grants-Breakthrough-Machine-Designation-for-Haystack-MRD-Circulating-Tumor-DNA-Take a look at-from-Quest-Diagnostics
2. “Minimal residual illness,” by Nationwide Most cancers Institute. https://www.most cancers.gov/publications/dictionaries/cancer-terms/def/minimal-residual-disease
3. “What Sufferers with Most cancers Have to Know About Circulating Tumor DNA,” by CURE, Sept. 4, 2024. https://www.curetoday.com/view/what-patients-with-cancer-need-to-know-about-circulating-tumor-dna
4. “Oncologists Report Seeing Extra Superior Cancers and Say Present Assessments Are Not Catching Most cancers Recurrence Early Sufficient, New Quest Diagnostics Report Finds,” by Quest Diagnostics. Information launch; Could 13, 2025. https://newsroom.questdiagnostics.com/2025-05-13-Oncologists-Report-Seeing-Extra-Superior-Cancers-and-Say-Present-Assessments-Are-Not-Catching-Most cancers-Recurrence-Early-Sufficient,-New-Quest-Diagnostics-Report-Finds
5. “Immunotherapy Might Substitute Surgical procedure, Enabling Sufferers To Retain Their Organs and Improve Their High quality of Life,” by Memorial Sloan Kettering Most cancers Heart. April 27, 2025; https://www.mskcc.org/news-releases/immunotherapy-could-replace-surgery-enabling-patients-to-retain-their-organs-and-enhance-their-quality-of-life