India Launches First Non-Invasive and FDA Approved Test to Detect Early Alzheimer’s

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India now offers a non-invasive and comprehensive test to detect Alzheimer’s disease—marking a significant step forward in diagnosing this neurodegenerative condition. Developed and launched by Dr Dangs Labs, the test aims to bridge the diagnostic gap for millions suffering from cognitive decline.

Currently, there is no cure for Alzheimer’s, a disease that affects an estimated 8.8 million Indians aged over 60. Alarmingly, doctors are also observing its onset in younger individuals, with some cases reported in people as young as 45.

What Is the New Test?

Called Dendrite Dx, the test has received clearance from the US Food and Drug Administration (USFDA). It combines a 15-minute cognitive assessment with advanced blood biomarker testing and a proprietary scoring system known as APS2 (Amyloid Probability Score 2).

This scoring system—developed in collaboration with a US-based lab—ranges from 0 to 100 and indicates the likelihood of amyloid plaque buildup in the brain, a known marker of Alzheimer’s.

Why This Test Matters

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Until now, patients seeking a definitive diagnosis had limited options: invasive lumbar punctures or expensive imaging like MRIs, both of which have limitations. As per The Print, Dr Navin Dang, founder and director of Dr Dangs Labs, emphasized the unmet need this test addresses.

“This test fills a critical diagnostic gap,” Dr Dang said. “It allows for earlier detection without invasive procedures.”

Early diagnosis can significantly improve a patient’s quality of life by enabling timely care planning, access to treatment options, and better management of symptoms.

How the Test Works

The Dendrite Dx test is intended for adults who:

  • Have a family history of Alzheimer’s or dementia
  • Experience brain fog, memory lapses, or trouble concentrating
  • Live with lifestyle risk factors such as diabetes, hypertension, or obesity

Three Package Options

  1. Basic Package – Includes the 15-minute cognitive assessment
  2. Advanced Package – Adds blood biomarker testing for:
    • pTau-217, a highly specific marker for Alzheimer’s
    • Amyloid beta 1-42, linked to plaque buildup
  3. Confirmatory Package – Adds tests for:
    • APO E, which indicates genetic risk
    • Comprehensive cognitive evaluation
    • General health markers like inflammation, kidney health, and blood sugar control
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When these physiological systems are out of balance, patients may experience poor memory, low focus, mood swings, or an increased risk of cognitive decline.

Accuracy and Reliability

Independent studies have shown that the blood biomarkers used in this test deliver high sensitivity and specificity—around 90%, reducing the likelihood of false positives or negatives.

“This makes them particularly valuable in reliably ruling out the disease,” Dr Dang explained.

The final diagnostic confirmation is conducted via PrecivityAD2, a test developed by C2N Diagnostics in the U.S. It uses liquid chromatography tandem mass spectrometry, a sophisticated method that detects Alzheimer’s-linked compounds in the blood.

What Will It Cost

Although the final pricing is yet to be confirmed, the test is expected to cost approximately ₹10,000, making it more accessible than many existing alternatives.

A Step Forward in Brain Health

Alzheimer’s disease currently affects 57 million people globally, according to the World Health Organization. With the introduction of Dendrite Dx, India moves a step closer to tackling this crisis through early, accessible, and accurate diagnosis.

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By identifying Alzheimer’s in its earliest stages, families and healthcare providers can make more informed decisions—offering hope in the fight against one of the world’s most devastating brain diseases.