Guardant Health (GH), Labcorp (LH) Gain Colorectal Screening Coverage

On July 30, 2026, Labcorp Holdings (LH) and Guardant Health (GH) each said on the same day's second-quarter earnings call that their non-colonoscopy colorectal cancer screening test had been added to the American Cancer Society screening guidelines and had won national payer coverage [1][2]. Guardant Health raised its full-year screening revenue guidance to $218 million to $230 million on the strength of it [2].

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Guidelines and payer lists, not FDA approval, decide whether a screening test gets ordered and paid

Colorectal cancer screening is routine care for US adults aged 45 and over, and a physician has two kinds of options. A colonoscopy requires bowel prep, sedation and a day off work, which is why many people put it off for years. The other option is a non-invasive test — nothing enters the body, and the patient either collects a small stool sample at home or has a tube of blood drawn at a collection site. Non-invasive tests exist to reach the people colonoscopy turns away.

Clearing the US Food and Drug Administration (FDA) only means a test can be sold legally. It does not mean a physician will order it or that a lab will be paid for it. Two other lists decide that: whether the American Cancer Society (ACS) screening guideline includes the test, and whether Medicare (CMS) or a large commercial insurer covers it. For a decade, only one FDA-approved non-invasive product sat on both lists — Exact Sciences' Cologuard, a home-collected test that reads DNA markers in stool [3].

Both lists opened this year to two products built on completely different principles. Labcorp's ColoSense uses a stool sample and reads RNA; Guardant Health's SHIELD is a blood draw. Both were picked up in the ACS guideline update of May 2026, and each then won coverage from a national payer [1][2]. Because outside bodies control those lists and no company owns them, clearing one type of product removes the protection the lists gave every other approved product of the same kind.

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One side reported revenue, test volume and covered lives; the other has no numbers yet

Guardant Health supplied the only quantified result so far. SHIELD testing revenue was $53 million in the second quarter on roughly 66,000 tests, against $15 million on roughly 16,000 tests a year earlier, at an average realized price of about $800 per test [2]. The company raised full-year screening revenue guidance to $218 million to $230 million and attributed the raise directly to ACS guideline inclusion and the UnitedHealth coverage policy. UnitedHealth is the largest commercial insurer in the US and the first major commercial insurer to cover SHIELD, effective August 1 [2].

Labcorp has disclosed no figures. Management said ColoSense launched nationwide in June, is included in the American Cancer Society guidelines and has CMS coverage, and that early signals are encouraging — while stressing that it is still very early and that broad payer access will take time. No revenue or test volume was given [1].

The side losing exclusivity has not changed its public language. Exact Sciences' most recent available quarterly report still describes Cologuard as the first and only FDA-approved stool-DNA non-invasive colorectal screening test [3], and that language predates both of this quarter's developments. In the same period the company guided 2025 screening revenue to $2.51 billion to $2.52 billion, roughly three-quarters of its $3.25 billion of revenue that year [4][5]. Together these facts support one conclusion and no more: the reimbursed non-invasive screening channel is open to three products at once for the first time, and only one of the two new entrants has put a number on it.

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Reimbursement eligibility shifts from one product to three, and both demand and pricing get renegotiated

Anyone who wanted a non-invasive screen and wanted insurance to pay for it previously had one route; now there are three. The physician's question moves from whether to order Cologuard to which of three collection methods to use, and patient preference — someone unwilling to handle a stool sample will take the blood draw — reaches different companies' revenue for the first time. The control point moves from a product's own approval status to the guideline committee's and the payers' lists, and neither of those favors whoever arrived first.

Pricing follows. Average realized price per test and the mix between commercial insurance and Medicare both have to reset with three products in the market. Two things are checkable from here: whether Guardant Health's commercial mix and realized price per SHIELD test move once coverage takes effect in the second half, and whether Labcorp discloses ColoSense revenue or test volume for the first time next quarter.

One boundary matters. Cologuard has not lost FDA approval or its guideline position; it has lost being the only one. Ownership has also changed — Abbott closed its roughly $21 billion acquisition of Exact Sciences on March 23, 2026 [6] — so Cologuard's quarterly performance is no longer disclosed on its own, and the side being diluted cannot be observed directly from here.

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Companies exposed to this change

• Abbott (ABT): A medical device and diagnostics company that closed its acquisition of Exact Sciences in March 2026, making Cologuard its product [6]. It faces the same ACS guideline update and the same payer decisions, so a reimbursement channel going from exclusive to shared lands on the business it just bought.
• Quest Diagnostics (DGX): One of the largest independent lab and patient service center networks in the US. A blood-based screening test requires a draw at a collection site first, so rising covered blood-screening volume routes samples through networks of this kind.
• Surgery Partners (SGRY): Operates ambulatory surgery centers, with gastroenterology as one of its core specialties. A positive non-invasive screen still requires a diagnostic colonoscopy, so more covered non-invasive screening changes where diagnostic colonoscopies come from.

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Sources

[1] Drillr · Labcorp Holdings (LH) · 2026-07-30 · FY2026 Q2 earnings call

[2] Drillr · Guardant Health (GH) · 2026-07-30 · FY2026 Q2 earnings call

There are approximately 120 million average risk individuals in U.S. eligible for colorectal cancer screening, representing a $50 billion U.S. addressable screening market. As a result of ACS guideline inclusion and the United Health Coverage Policy, we believe that approximately 70 million lives, or roughly 60% of the market, is now covered for shield blood tests.

[3] Drillr · Exact Sciences (EXAS) · 2025-11-03 · FY2025 Q3 10-Q

[4] Drillr · Exact Sciences (EXAS) · 2025-11-04 · FY2025 Q3 earnings call

[5] Drillr · Exact Sciences (EXAS) · 2025-12 · FY2025 annual financials

[6] Drillr · Abbott (ABT), Exact Sciences (EXAS) · 2026-03-23 · 8-K merger completion

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