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Diagnostics

SimpleScreen CRC

Freenome · FDA approval

A second blood-based colorectal cancer screening test reaches the US market.

Clinical summary

A cell-free DNA blood test for colorectal cancer screening in average-risk adults aged 45 and older, commercialized in the US by Abbott. In PREEMPT CRC (more than 48,000 participants), sensitivity for colorectal cancer was 81.1% and specificity 90.4%, but sensitivity for advanced precancerous lesions was only 13.7%. A positive result must be followed by colonoscopy, and the test does not replace colonoscopy in high-risk patients.

Read the primary source: Freenome press release

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Diagnostics

Signatera CDx

Natera · FDA approval (companion diagnostic)

A ctDNA test now selects bladder cancer patients for adjuvant immunotherapy.

A tumor-informed circulating tumor DNA assay approved to identify patients with muscle-invasive bladder cancer who are ctDNA-positive after cystectomy and eligible for adjuvant atezolizumab, approved for this use the same day. In IMvigor011 (250 ctDNA-positive patients), atezolizumab improved median disease-free survival (9.9 vs 4.8 months; HR 0.64) and overall survival (32.8 vs 21.1 months; HR 0.59) versus placebo.

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Drugs

Juvmo (tavapadon)

AbbVie · FDA approval

First selective D1/D5 dopamine agonist approved for Parkinson's disease.

A once-daily oral tablet for adults with Parkinson's disease, with or without levodopa; unlike existing agonists, which act mainly on D2/D3 receptors, it selectively activates D1/D5. In TEMPO-3, as adjunct to levodopa in patients with motor fluctuations, daily 'on' time without troublesome dyskinesia rose by 1.7 hours versus 0.6 hours with placebo. Warnings include orthostatic hypotension, hallucinations, dyskinesia and impulse-control urges.

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Medical Technology

Libre Duo

Abbott · FDA De Novo

First wearable sensor that tracks ketones and glucose together.

A 10-day sensor for people with diabetes aged 2 and older that measures ketones and glucose in interstitial fluid every minute and sends readings, trends and rising-level alerts to a smartphone. Across six clinical studies in more than 600 participants it tracked clinically meaningful ketone differences, including elevated ketones before the onset of diabetic ketoacidosis. Ketone readings should be interpreted with glucose values and symptoms, and do not replace confirmatory testing before treatment decisions.

EndocrinologyView Innovation