Haystack MRD Test Gets Breakthrough Designation in Stage 2 Colorectal Cancer

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation for the Haystack minimal residual disease (MRD) test which identifies MRD-positive patients with stage 2 colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling, according to a news release from Quest Diagnostics.

"We are committed to working with the FDA and our research partners to validate the use of Haystack MRD in a variety of solid tumors, building on this first designation for an early-stage colorectal cancer," Dan Edelstein, vice president and general manager, Haystack Oncology, said in the news release.

He continued, "Our goal is to deliver highly accurate, personalized monitoring of treatment response and recurrence to more patients, both in clinical care and in pharmaceutical trials, and this Breakthrough Designation brings us closer to our goal."

The Haystack MRD test recently received a new designation, adding to the growing evidence of its value in both clinical care and drug development. Quest introduced a laboratory-developed version of Haystack MRD in late 2024 and is now expanding its availability for oncologists and pharmaceutical partners, as per the release.

The FDA’s Breakthrough Devices Program is designed to speed up access to medical devices that may offer more effective diagnosis or treatment for serious or life-threatening conditions. Devices accepted into the program still go through the FDA’s rigorous review process to ensure safety and effectiveness, but the pathway helps shorten development and review times. This means patients and their doctors may gain earlier access to promising new technologies through premarket approval, 510(k) clearance, or De Novo authorization.

What is ctDNA Minimal Residual Disease?

A growing body of research shows the value of circulating tumor DNA (ctDNA) minimal residual disease (MRD) tests in finding cancer that may remain or return in solid tumors. These tests look for very small amounts of tumor DNA in the blood, which can reveal signs of recurrence months before it is visible through scans or other standard monitoring.

Having this early information may help doctors personalize follow-up care, adjust treatment when needed, and step in before the cancer progresses. In fact, nearly all oncologists — 96% in a recent Harris Poll survey conducted for Quest Diagnostics — said MRD testing has the potential to detect cancer recurrence earlier than current methods, according to the release.

What is Haystack Minimal Residual Disease?

Haystack MRD is a highly sensitive and specific liquid biopsy test that uses circulating tumor DNA (ctDNA) — tiny fragments of tumor-derived DNA in the bloodstream — to detect residual, recurrent, or resistant cancer in patients with solid tumors, potentially enabling earlier intervention.

Developed by cancer genomics and liquid biopsy experts, it has been used in multiple clinical trials and research studies with leading institutions in the U.S., Canada, and Australia, and is in use at more than 75 top cancer and academic centers.

Now available clinically through Quest Diagnostics’ oncology testing portfolio, Haystack MRD is also offered as an investigational device for clinical trials at Haystack Oncology laboratories in Baltimore, Maryland; Hamburg, Germany; and Helsinki, Finland.

What is Stage 2 Colorectal Cancer?

According to the National Cancer Institute’s website, cancer.gov, stage 2 colorectal cancer has three subgroups: 2a, 2b and 2c:

• In stage 2a, the cancer has grown through the muscle layer of the colon or rectum wall and reached the serosa, which is the outermost layer of the wall.
• In stage 2b, the cancer has spread through the serosa into the tissue that lines the organs in the abdomen, called the visceral peritoneum.
• In stage 2c, the cancer has spread through the serosa of the colon or rectum wall and reached nearby organs.

References

1. “FDA Grants Breakthrough Device Designation for Haystack MRD Circulating Tumor DNA Test from Quest Diagnostics.” Quest Diagnostics. News Release. Aug 25.
2. “Stage II Colorectal Cancer,” by the National Cancer Institute. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/stage-ii-colorectal-cancer

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