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Terumo Neuro agrees to buy Arsenal Medical and its NeoCast liquid embolic Medtronic clears Affera Prism-2 mapping software and CE marks a PulseSelect proximity adapter WHO opens device prequalification to condoms, IUDs and AI tuberculosis screening software VertigoDx clears a smartphone nystagmus system under K260566 Autonomix says FDA backed a Class II path for its sensing catheter and targets clearance in 15 months Ceribell clears three EEG algorithms under K261712 with no age limit Oura shelves its $2.2B Nasdaq IPO four weeks after filing Nyxoah hires former Teleflex CEO Liam Kelly to run the Genio US launch VCD Medical clears VEnice, a clip that closes varicose veins without heat Terumo Neuro agrees to buy Arsenal Medical and its NeoCast liquid embolic Medtronic clears Affera Prism-2 mapping software and CE marks a PulseSelect proximity adapter WHO opens device prequalification to condoms, IUDs and AI tuberculosis screening software VertigoDx clears a smartphone nystagmus system under K260566 Autonomix says FDA backed a Class II path for its sensing catheter and targets clearance in 15 months Ceribell clears three EEG algorithms under K261712 with no age limit Oura shelves its $2.2B Nasdaq IPO four weeks after filing Nyxoah hires former Teleflex CEO Liam Kelly to run the Genio US launch VCD Medical clears VEnice, a clip that closes varicose veins without heat

Commercial launch

Abbott starts selling Freenome's blood test for colorectal cancer

MedDevice Startups Staff · 2 days ago · 2 min read · Via MedTech Dive

Abbott began US sales of SimpleScreen CRC on September 30. Freenome manufactures the test and Abbott distributes it. The blood test looks for circulating cell-free DNA in average-risk adults 45 and older, and FDA approved it in summer 2026.

In the registrational data the test caught 81.1 percent of colorectal cancers and 63.5 percent of stage I cancers, at 90 percent specificity. Sensitivity for advanced precancerous lesions was 13.7 percent. Abbott says Medicare covers the test and eligible patients pay nothing out of pocket under Part B.

Abbott paid $21B for Exact Sciences in March 2026, which brought the Cologuard Plus stool test. The sales force already calling on those primary care offices is the asset Freenome could not have built on its own, and the 13.7 percent lesion sensitivity is the figure the gastroenterology societies will keep raising.

Questions & Answers

What is Freenome's SimpleScreen CRC test?

SimpleScreen CRC is a blood-based colorectal cancer screening test from Freenome that detects circulating cell-free DNA in average-risk adults 45 and older. FDA approved it in summer 2026 and Abbott began US distribution on September 30, 2026.

How accurate is Freenome's SimpleScreen CRC?

SimpleScreen CRC showed 81.1 percent sensitivity for colorectal cancer, 63.5 percent sensitivity for stage I disease and 90 percent specificity. Sensitivity for advanced precancerous lesions was 13.7 percent.

Is SimpleScreen CRC covered by insurance?

Abbott said SimpleScreen CRC is covered by Medicare and that eligible patients have no out-of-pocket cost under Part B.

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