Evolving Landscape For Alzheimer's Blood Tests Gains Momentum Amid Inaccuracy Concerns
Portfolio Pulse from Vandana Singh
Blood tests for Alzheimer's diagnosis are gaining momentum, with Quest Diagnostics and LabCorp offering consumer-available tests. However, concerns about accuracy persist as none have FDA approval. The FDA is considering stricter regulations. Meanwhile, drugs like Biogen/Eisai's Leqembi and Eli Lilly's donanemab highlight the need for precise diagnosis. Medicare revised its policy on amyloid PET scans, and new NIH-funded research shows promise for early detection.
January 12, 2024 | 6:17 pm
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NEUTRAL IMPACT
Quest Diagnostics offers the AD-Detect Test for Alzheimer's, the first consumer-available blood test, despite no FDA approval and accuracy concerns.
Quest Diagnostics' involvement in Alzheimer's blood testing could be significant, but the lack of FDA approval and concerns about accuracy may temper investor enthusiasm in the short term.
CONFIDENCE 70
IMPORTANCE 60
RELEVANCE 70
NEUTRAL IMPACT
LabCorp launched the ATN Profile, a blood-based test for Alzheimer's, categorized as a laboratory-developed test with limited FDA oversight.
LabCorp's entry into the Alzheimer's testing market is notable, but the current regulatory environment and accuracy questions may limit the short-term impact on the stock.
CONFIDENCE 70
IMPORTANCE 60
RELEVANCE 70
POSITIVE IMPACT
Biogen, in partnership with Eisai, has FDA-approved Alzheimer's drug Leqembi, emphasizing the need for accurate diagnostic tests.
Biogen's FDA-approved drug for Alzheimer's could see increased demand as diagnostic tests improve, potentially benefiting the company's revenue and stock price.
CONFIDENCE 75
IMPORTANCE 80
RELEVANCE 60
POSITIVE IMPACT
Eisai Limited, in collaboration with Biogen, has developed Leqembi for Alzheimer's, which is likely to increase the demand for accurate diagnostics.
Eisai's partnership with Biogen on the Alzheimer's drug Leqembi could benefit from advancements in diagnostic testing, potentially impacting the company's performance.
CONFIDENCE 70
IMPORTANCE 70
RELEVANCE 50
POSITIVE IMPACT
Eli Lilly's Alzheimer's drug donanemab is expected to receive FDA approval soon, which could be influenced by the development of accurate blood tests.
Eli Lilly's potential FDA approval for donanemab could be positively impacted by the progress in Alzheimer's blood testing, which may drive the drug's usage and benefit the company.
CONFIDENCE 75
IMPORTANCE 80
RELEVANCE 60