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Mainstreaming Genetic Testing

Executive Summary

Genetic testing is progressing at a faster pace than anyone envisioned just a few years ago. The question now is not whether genetic testing will ever be a business, but whether it will evolve.

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The Murky Regulatory Arena of Genetic Testing

The FDA has undertaken several measures to make the regulatory process less burdensome for diagnostics companies, but these may not be enough to incentivize companies to take their new genetic tests through the approval process. At the same time, confusion reigns: a special HHS advisory committee on genetic testing has been disbanded, and the FDA is reviewing its jurisdiction to regulate home brews, which are the dominant route to commercialization for genetic tests. Some critics worry that these developments may stifle innovation and companies are waiting for clarity.

Eisai Plots A Meticulous Path To CMS Coverage For Lecanemab

The company believes the Phase III Clarity AD results offer a high level of evidence that may convince the Centers for Medicare and Medicaid Services to change its stance on anti-amyloid antibodies for lecanemab. 

Symptoms Change But Savings OTC Drugs Deliver For US Health Care Spending Continue Growing

Substantially more consumers in 2022 report sleep issues, allergies and skin problems than in 2018 while using quit smoking aids has dropped, according to CHPA’s latest “Value of OTC Medicines” survey. Average annual household spending on OTCs is $645.

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