Receiving FDA breakthrough designation for its ctDNA solid-tumor MRD test validates the technology and signals a major push towards commercialization. This will require significant investment in marketing, sales force training, and scaling up lab operations to meet anticipated demand.
Filing excerpt
In 2025, we received a breakthrough device designation from the U.S. Food and Drug Administration (“FDA”) for our Haystack Oncology MRD test for patients with an early stage colorectal cancer diagnosis.
What this signalsFilings often name leadership changes, deals and spending plans.
Technologies
Vendors
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This page shows a preview. The full sec-10k record in the Signal API and MCP can also have these 8 fields. Some fields are empty for some signals.
Company
linkedin_urlValue in the APIindustriesValue in the APIemployee_count_lowValue in the APIemployee_count_highValue in the APIrevenueValue in the APIdescriptionValue in the APISignal
signal_nameValue in the APIassociationValue in the APIGET /v1/signals/74041817-47ca-42f6-b00d-419e0a6c5b9c returns this record as JSON. POST /v1/companies/enrich returns every signal for questdiagnostics.com.
{
"signal_id": "74041817-47ca-42f6-b00d-419e0a6c5b9c",
"signal_type": "sec-10k",
"signal_subtype": "productLaunch",
"detected_at": "2026-03-03T05:59:31.732+00:00",
"company": {
"name": "Quest Diagnostics",
"domain": "questdiagnostics.com"
},
"data": {
"detail": "Receiving FDA breakthrough designation for its ctDNA solid-tumor MRD test validates the technology and signals a major push towards commercialization. This will require significant investment in marketing, sales force training, and scaling up lab operations to meet anticipated demand.",
"metrics": {
"timeframe": "current_year"
},
"summary": "Quest's Haystack Oncology MRD test received FDA breakthrough designation in 2025, accelerating commercialization",
"excerpts": "In 2025, we received a breakthrough device designation from the U.S. Food and Drug Administration (“FDA”) for our Haystack Oncology MRD test for patients with an early stage colorectal cancer diagnosis.",
"relevance": 0.8,
"sentiment": "positive",
"confidence": "high",
"source_url": "https://www.sec.gov/Archives/edgar/data/1022079/000102207926000015/dgx-20251231.htm",
"filing_date": "2026-02-26",
"filing_year": 2026,
"fiscal_year_end": "12/31",
"sales_relevance": "Go-to-market support",
"signal_category": "strategic",
"vendors_mentioned": [
"Haystack Oncology"
],
"technologies_mentioned": [
"circulating tumor DNA",
"ctDNA",
"MRD"
]
}
}
curl https://signals.autobound.ai/v1/signals/74041817-47ca-42f6-b00d-419e0a6c5b9c \
-H "X-API-KEY: $AUTOBOUND_API_KEY"curl -X POST https://signals.autobound.ai/v1/companies/enrich \
-H "X-API-KEY: $AUTOBOUND_API_KEY" \
-H "Content-Type: application/json" \
-d '{"domain":"questdiagnostics.com","limit":20}'Long text fields are shortened on this page.
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