Distributed via OpenLoop Health, the supplemental proteomic assay demonstrated 92% sensitivity and 93% specificity in clinical validation.
Astrin Biosciences announced that its Certitude blood test for supplemental breast cancer screening is now available to eligible women across 48 states through a distribution partnership with telehealth platform OpenLoop Health.
The non-imaging test is designed to detect early breast cancer signals from a standard blood draw, offering an additional screening option for individuals who face barriers to supplemental imaging. Nearly half of all women have dense breast tissue, a characteristic that increases breast cancer risk while diminishing the sensitivity of standard mammography. While supplemental imaging modalities exist, they can be costly, time-consuming, and inconsistently accessible depending on patient geography.
“As a physician, I frequently discuss with patients who have dense breast tissue that while their mammogram is normal, dense tissue can make cancers more difficult to see on imaging,” says Dr Tanya Gupta, medical director at Astrin Biosciences, in a release. “Certitude provides another data point from a simple blood sample that may help patients and their physicians better understand their individual risk. Offering Certitude through telehealth has the potential to make this additional information more accessible to women and their physicians.”
Proteomic Platform and Clinical Validation
Certitude runs on Astrin’s deep proteomic profiling platform, which couples high-resolution mass spectrometry with machine learning algorithms. The assay analyzes thousands of proteins from a small blood sample to capture molecular signatures associated with breast malignancy.
In a clinical validation study comprising 1,242 women, the assay demonstrated 92% sensitivity and 93% specificity across various breast cancer stages and subtypes. The study also reported a negative predictive value exceeding 99.9%.
Testing is performed through Astrin Biosciences Laboratories, which is accredited by the College of American Pathologists, certified under Clinical Laboratory Improvement Amendments regulations, and qualified to conduct high-complexity clinical laboratory testing.
“For too long, geography and fragmented access have stood between women and the comprehensive screening they deserve,” says Jayant Parthasarathy, CEO of Astrin Biosciences, in a release. “Partnering with OpenLoop allows us to meet women wherever they are with an easy, trusted path to earlier detection. A simple blood draw, supported by physician-led telehealth, transforms what has often been an anxious, uncertain journey into one of confidence and trust. Today’s milestone ensures that the peace of mind of earlier detection is finally accessible to millions more women across the country.”
Nationwide Distribution Details
Under the partnership, eligible patients in 48 states can access physician evaluation and order the test online via OpenLoop Health’s digital platform.
“Access to care shouldn’t depend on your zip code. That’s the problem we built OpenLoop to solve,” says Jon Lensing, CEO and co-founder of OpenLoop Health, in a release. “Certitude is a meaningful new tool that will enable more women to get answers without waiting for the right specialist to be nearby.”
Eligible women in New York and Hawaii can currently complete medical eligibility screenings and join a waitlist pending regulatory availability in those two states.
