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Certitude breast cancer blood test expands to 75 million women via telehealth

Certitude breast cancer blood test expands to 75 million women via telehealth

New Capabilities

Astrin Biosciences and OpenLoop Health make the non-imaging test available across 48 states

September 29th, 2026: OpenLoop Health partnership reaches 75 million women

Overview

Updated Sep 29

For women with dense breast tissue, a mammogram detects only about half of cancers. On September 29, Astrin Biosciences said its Certitude blood test, which flags early-stage breast cancer from a simple blood draw, is now available to 75 million women through telehealth infrastructure company OpenLoop Health.

The test doesn't replace imaging. It's a supplemental screen prescribed after a mammogram; a positive result steers a woman toward MRI, while a negative one, with a 99.9% negative predictive value, supports reassuring her. Whether the access expansion changes outcomes depends on insurance coverage and how many clinicians order it.

Why it matters

Women with dense breasts have a new blood test to guide follow-up screening, now available by telehealth across 48 states

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Key Indicators

75M
Women with access
Reached through the OpenLoop Health telehealth partnership.
48
States offering Certitude
Currently unavailable in New York and Hawaii.
92.6%
Sensitivity
Cancer detection rate in the 397-woman validation arm of the peer-reviewed study.
92.3%
Specificity
Rate at which the test correctly identifies women without cancer.
99.87%
Negative predictive value
Likelihood that a negative result means no breast cancer.

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People Involved

Jayant Parthasarathy
Jayant Parthasarathy
Founder and CEO, Astrin Biosciences
Leading Certitude's national rollout
 Dr. Tanya Gupta
Dr. Tanya Gupta
Medical Director, Astrin Biosciences
Appointed September 16, 2026

Organizations Involved

Astrin Biosciences
Astrin Biosciences
Biotechnology company
Developer of Certitude, scaling nationwide

St. Paul-based biotech combining deep proteomics with machine learning to detect cancer from blood samples.
OpenLoop Health
OpenLoop Health
Telehealth infrastructure provider
Distribution partner for Certitude

White-label telehealth partner supplying licensed clinicians and virtual care technology for remote care programs.

Timeline

September 2024 September 2026

7 events Latest: September 29th, 2026 · 1 week ago
Tap a bar to jump to that date

  1. OpenLoop Health partnership reaches 75 million women

    Latest Partnership

    Telehealth infrastructure deal expands Certitude access to 75 million women across 48 states.

  2. Certitude becomes available via telehealth in 48 states

    Expansion

    Astrin announces remote access for eligible women; New York and Hawaii excluded.

  3. Dr. Tanya Gupta named Medical Director

    Leadership

    Breast oncologist joins Astrin as the test scales nationwide.

  4. Peer-reviewed study validates Certitude

    Research

    Validation arm of 397 women showed 92.6% sensitivity, 92.3% specificity, and 99.87% negative predictive value.

  5. Astrin launches Certitude blood test

    Launch

    First non-imaging, blood-based early detection test for breast cancer; launch results showed 92% sensitivity and 93% specificity.

  6. Certitude available by prescription at early access sites

    Expansion

    Rollout begins at partner health systems and OB-GYN clinics in select markets before broader national release.

  7. FDA requires breast density reporting

    Rule Change

    Mammogram reports must now tell women whether they have dense breast tissue, creating demand for follow-up screening options.

Scenarios

1

Major insurer or Medicare covers Certitude, adoption accelerates

Possible Resolves by End of 2027

Discussed by: Inside Precision Medicine, which reported Astrin is preparing direct-to-consumer promotion as it pushes for reimbursement

Certitude is prescription-only and cash-pay until payers add coverage. If a national insurer or Medicare covers it for dense-breast women, telehealth orders through OpenLoop would climb sharply. A coverage decision is the clearest signal that the test has moved from niche to standard supplemental screening.

2

Certitude becomes standard supplemental screening for dense breasts

Possible Resolves by End of 2028

Discussed by: Pharmacy Times, which reported the test targets the gap left by the FDA breast density rule

Now that breast density reporting is routine, professional societies and health systems could adopt blood-based supplemental screening as a guideline. If a major society recommends it or a large health system adds it to dense-breast protocols, Certitude would move from available to broadly recommended.

3

Rival breast cancer blood test reaches the market

Possible Resolves by End of 2028

Discussed by: Pharmacy Times, which noted the liquid biopsy field is actively pursuing breast cancer detection

Liquid biopsy companies including Guardant Health and Grail are developing cancer detection blood tests. An FDA-cleared competitor targeting breast screening would pressure Certitude on price and performance. The niche Astrin entered would become crowded.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

July 2024

Guardant Health Shield approval (2024)

Guardant Health won FDA approval for Shield, a blood test that screens for colorectal cancer in average-risk adults. It gave patients a blood-draw alternative to colonoscopy and stool-based tests.

Then

Shield launched commercially and Guardant pursued Medicare coverage.

Now

The approval showed regulators would clear blood-based cancer screening, opening a path for similar tests.

Why this matters now

Certitude follows the same template: a blood test designed to expand who gets screened for cancer and how.

August 2014

Exact Sciences Cologuard approval (2014)

The FDA approved Cologuard, a stool-based DNA test for colorectal cancer, as an option for people avoiding colonoscopies.

Then

Cologuard gained Medicare and private payer coverage over several years.

Now

It proved a convenient, non-invasive test can shift screening behavior and build a large market, but coverage took time.

Why this matters now

Shows both the potential and the friction of expanding screening access through a new test.

June 2021

Grail Galleri launch (2021)

Grail launched Galleri commercially, a blood test using DNA methylation patterns to detect signals from more than 50 cancer types with a single draw.

Then

Galleri sold as a cash-pay test around $949 with limited insurance coverage.

Now

It illustrated the gap between a technically advanced blood test and broad reimbursement.

Why this matters now

Certitude faces the same question: a strong test does not guarantee payer uptake.

Sources

(7)
+3
PR Newswire Inside Precision Medicine Pharmacy Times The Flowspace PR Newswire PR Newswire PR Newswire