C2N Diagnostics, a leader in advanced brain health diagnostics, recognizes the landmark decision by the U.S. Food and Drug Administration to approve anti-amyloid antibody lecanemab for intravenous use in the treatment of Alzheimer’s disease.

As stated in the FDA-approved LEQEMBI label, treatment with LEQEMBI should only be initiated in patients with mild cognitive impairment or mild dementia stage of the disease and confirmed presence of amyloid beta (Ab) pathology. C2N believes it is uniquely positioned to support the medical community in confirming this pathology with its Precivity™ portfolio of tests.

The newest addition to C2N’s clinical offering will be the PrecivityAD2™ test, which uses a proprietary Amyloid Probability Score 2 (APS2) result that incorporates precise measurements of p-tau217/np-tau217 Ratio and Ab42/40 Ratio into an analytically and clinically validated algorithm. The APS2 result correlates significantly and more robustly with brain amyloid pathology as measured by PET scan than to the individual Ab42/40 and phosphorylated tau biomarker measurements considered separately. The PrecivityAD2 blood test is intended for patients aged 55 and older with signs or symptoms of mild cognitive impairment or dementia, who are undergoing evaluation for Alzheimer’s disease or other causes of cognitive decline.

Healthcare providers are encouraged to visit www.precivityad.com to set up, register, and confirm accounts in advance of C2N’s planned launch of PrecivityAD2 in mid-August.

Providers will have the option to also order the separate Precivity-ApoE proteotype blood test to determine their patients’ ApoE genotype status, which may assist in medical management and treatment decisions of patients with Alzheimer’s disease who are candidates for amyloid-reducing therapies.

Given the strong interest in LEQEMBI, it is anticipated meeting the testing requirements to receive treatment will necessitate the use of additional testing methods beyond a PET scan or spinal tap, both of which may be expensive, inaccessible, and uncomfortable.

Last year C2N Diagnostics and Eisai Co., Ltd., announced they had entered into a collaboration to build awareness about how blood tests for cognitive impairment, including Alzheimer’s disease, may help patients receive a timely diagnosis and appropriate treatment, especially in traditionally underserved communities.

 

Source:businesswire.com

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