Haystack Oncology (Quest Diagnostics NYSE: DGX) announced a research collaboration with Rutgers Cancer Institute and RWJBarnabas Health to evaluate Haystack MRD, a circulating tumor DNA (ctDNA) test, in a prospective phase II trial titled MRD-PORT (NCT06979661) to guide postoperative radiation and systemic therapy in stage II/III non-small cell lung cancer.
Key context: an April 2025 NEJM study found Haystack MRD identified clinical complete response at a median of 1.4 months vs >6 months by imaging, and the test received FDA Breakthrough Device Designation in August 2025.
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Positive
FDA Breakthrough Device Designation in August 2025
NEJM April 2025: ctDNA detected response at 1.4 months median
Launched phase II MRD-PORT trial NCT06979661 for stage II/III NSCLC
Negative
None.
Market Context
This announcement sets a clear timetable for third-quarter 2025 results, giving investors a defined ...
Analysis
This announcement sets a clear timetable for third-quarter 2025 results, giving investors a defined point to reassess Off The Hook YS Inc.’s progress following its recent IPO that raised $15,000,000. Recent news has covered expansion plans and promotional efforts, alongside notable insider purchases reported on Form 4 filings. Heading into the report, key factors to monitor include revenue trends since the IPO, operational updates related to the new Florida office, and any commentary on growth initiatives.
Key Figures
Trial phase:Phase IICancer stage:Stage II/IIIMedian detection time:1.4 months+5 more
8 metrics
Trial phasePhase IIMRD-PORT trial in stage II/III NSCLC
Cancer stageStage II/IIINon-small cell lung cancer postoperative setting
Median detection time1.4 monthsTime for Haystack MRD to identify clinical complete response
Imaging detection timeOver 6 monthsTime for imaging tests to identify clinical complete response
Oncologist agreement96%Survey respondents saying MRD testing may identify recurrence earlier
Breakthrough designation dateAugust 2025FDA Breakthrough Device Designation for stage II colorectal cancer use
Journal publication dateApril 2025NEJM study using Haystack MRD as liquid biopsy surrogate
Prior collaboration year2023Earlier Rutgers study in early-stage triple-negative breast cancer
Closing of IPO raising $15M gross proceeds at $4.00 per share.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Pattern Detected
Early trading history shows mixed reactions: expansion news and conferences saw positive moves, while the IPO and a tax-related positive update were followed by declines.
Recent Company History
Over recent months, Off The Hook YS Inc. completed its IPO on November 14, 2025, selling 3,750,000 shares at $4.00 for $15,000,000 in gross proceeds, followed by a -8.38% next-day move. A new Jupiter, Florida office for its Autograph Yacht Group division on November 25, 2025 preceded a 7.57% gain. Subsequent promotional and conference announcements around tax depreciation benefits and the NobleCon21 presentation produced modest, mixed price reactions, framing today’s earnings-date notice within an early, still-forming trading pattern.
"a highly sensitive circulating tumor DNA (ctDNA) minimal residual disease"
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.
ctdnamedical
"The study will evaluate ctDNA in patients with stage II/III NSCLC"
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.
minimal residual diseasemedical
"a highly sensitive circulating tumor DNA (ctDNA) minimal residual disease (MRD) test"
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.
non-small cell lung cancermedical
"patients with stage II/III non-small cell lung cancer (NSCLC)"
A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.
adjuvant therapymedical
"who may benefit from adjuvant therapy in accordance with therapeutic product labeling"
Adjuvant therapy is an extra medical treatment given after the main treatment—often surgery—to reduce the chance that a disease will come back, such as additional drugs, radiation, or immune-based treatments. For investors it matters because successful adjuvant treatments can expand the market for a drug, influence regulatory approval and reimbursement, and change revenue forecasts much like a protective follow-up step that prevents problems from reappearing.
immunotherapymedical
"systemic therapy, including chemotherapy, immunotherapy, or targeted therapy"
Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.
targeted therapymedical
"systemic therapy, including chemotherapy, immunotherapy, or targeted therapy"
A targeted therapy is a medical treatment designed to attack a specific feature of diseased cells—such as a protein or genetic change—while sparing healthy tissue. For investors, it matters because these precise treatments can be more effective and have clearer paths to approval and market demand than broad drugs; think of them as a guided tool rather than a blunt instrument, which can mean higher returns if safety and effectiveness are proven.
breakthrough device designationregulatory
"the FDA granted Breakthrough Device Designation to Haystack MRD"
A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.
Wilmington, NC, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Off The Hook YS Inc. (NYSE: “OTH”, or “Off the Hook Yachts”), America's largest buyer and seller of pre-owned boats, will announce its third quarter 2025 financial and operating results on Monday, December 15, 2025, after market close. The announcement will be followed by a live earnings conference call at 4:30 p.m. Eastern time.
To participate in the call, please dial (800) 715-9871 (domestic), or (646) 307-1963 (international). The conference passcode is 5863262. This call is being webcast and can be accessed using the conference passcode 5863262, on the Investor Relations section of the company's website at https://investor.offthehookyachts.com/. The online replay will be available for a limited time beginning immediately following the call.
About Off The Hook YS Inc.
Founded in 2012, Off The Hook YS Inc. has become one of America's largest buyers and sellers of pre-owned boats. Headquartered in Wilmington, North Carolina, with operations throughout the East Coast and South Florida, the Company acquires more than $100 million in boats and yachts annually. Off The Hook Yachts leverages AI-assisted valuation tools and a data-driven sales platform to bring speed and transparency to yacht transactions, supported by a nationwide network of offices and marinas offering brokerage, wholesale, and performance yacht sales. Customers can buy boats from our many boat brokers including Autograph Yacht Group, our premier yacht brokerage offering expert service, exclusive listings, and a refined approach to buying and selling yachts. They can finance them with our Azure Funding Division, our recreational loan broker and lender providing financing solutions for individuals, dealerships, and brokerages. Off the Hook Yacht Services provides high-quality maintenance, repair, and support services yacht servicing. Marine Asset Recovery provides asset recovery and repossession services. In addition to our company owned websites, Boatsandbuyers.com and Webuyboats.com provide boat auction and lead generation services. To purchase a boat, explore our inventory or visit the Autograph Yacht Group website.
This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” "will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Off The Hook YS Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the public offering filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Off The Hook YS Inc. undertakes no duty to update such information except as required under applicable law.
FAQ
What is the MRD-PORT trial (NCT06979661) announced Sept 22, 2025?
A prospective phase II study using Haystack MRD to guide postoperative radiation and systemic therapy in stage II/III NSCLC patients.
How does the April 2025 NEJM study affect DGX's Haystack MRD credibility?
The NEJM study reported Haystack MRD identified clinical complete response at a median of 1.4 months versus over 6 months by imaging, supporting its diagnostic value.
What did the FDA decision in August 2025 mean for Haystack MRD and DGX?
Haystack MRD received Breakthrough Device Designation in August 2025 for identifying MRD-positive stage II colorectal cancer patients post-surgery.
How might Haystack MRD influence postoperative therapy decisions in stage II/III NSCLC?
Patients testing ctDNA-positive after surgery may be considered for adjuvant radiation and systemic therapies tailored to tumor biology and clinical context.
When was the collaboration with Rutgers and RWJBarnabas announced?
The collaboration was announced on September 22, 2025 to evaluate Haystack MRD in the MRD-PORT trial.
Will the MRD-PORT trial change DGX clinical use timelines for Haystack MRD?
The study aims to assess ctDNA-guided postoperative decisions; any change to clinical use depends on trial results and subsequent regulatory or guideline actions.
