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RVTY's Latest Launch to Enable APOE Genotyping of Alzheimer's Disease

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Revvity, Inc. (RVTY - Free Report) announced the launch of the in-vitro diagnostic EURORealTime APOE assay in European countries that accept the CE mark on Oct. 2. The assay will likely enable accurate genotyping of the APOE gene.

It is worth mentioning that APOE genotyping allows the assessment of a patient’s risk for side effects before the start of an anti-amyloid (beta) therapy in Alzheimer's disease (AD).

The latest launch in European countries that accept the CE mark is expected to significantly boost Revvity’s EUROIMMUN business and solidify its foothold in the AD treatment space.

Significance of the Launch of Revvity’s APOE Assay

Per Revvity, the real-time EURORealTime APOE PCR test will likely allow simultaneous detection of the three most frequent APOE forms, designated E2, E3 and E4. With the new test now available from Revvity’s EUROIMMUN, only one reaction is required using genomic DNA isolated from a single blood sample to determine the patient’s APOE genotype. The assay processing can be automated to scalable degrees on Revvity instruments, including the EUROIMMUN PreNAT II and the chemagic 360 platforms.

Additionally, this approach to APOE genotyping will provide additional patient information and will enable a more personalized approach to anti-amyloid (beta) treatment for clinicians treating Alzheimer’s patients.

Revvity’s management believes that though new disease-modifying drugs for treating Alzheimer’s have been introduced for this incurable disease, it has been found to pose risks to certain patients. The patients taking these treatments with a certain form of the APOE gene have a significant risk of developing potentially life-threatening side effects, called ARIA (referring to edema or microbleedings in the brain). Thus, the new assay will likely be able to aid in determining the APOE genotype of patients before starting therapy, which is crucial for assessing the individual risk for potential negative consequences.

Industry Prospects in Favor of RVTY

Per a report by Grand View Research, the global Alzheimer's therapeutics market was valued at $4.05 billion in 2022 and is anticipated to witness a CAGR of approximately 19.9% between 2023 and 2030. Factors like the rising prevalence of AD and the growing demand for effective treatments for AD are likely to drive the market.

Given the market potential, the latest launch is expected to provide a significant boost to Revvity’s business.

Revvity’s Notable Development

In July, Revvity reported its second-quarter 2024 results, wherein it registered a slight improvement in its Diagnostics segment’s revenues. Management was optimistic about the company’s ongoing strong execution, which is expected to yield favorable results for the full year.

Comparison With RVTY’s Peers

A notable player in the Alzheimer’s treatment space and Revvity’s peer is Eli Lilly and Company (LLY - Free Report) . In September, LLY’s Kisunla (donanemab-azbt, 350 mg/20 mL every four weeks injection for IV infusion) was approved by the Ministry of Health, Labour and Welfare Japan for Alzheimer's treatment for adults with early symptomatic AD. This patient pool includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology.

In July, Eli Lilly’s Kisunla (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion) was approved by the FDA. Per LLY, Kisunla is applicable for Alzheimer's treatment for adults with early symptomatic AD, which includes people with MCI and people with the mild dementia stage of AD, with confirmed amyloid pathology.

Revvity’s peer, Biogen Inc. (BIIB - Free Report) , is another notable player in Alzheimer’s treatment space. In August, BIIB, along with Tokyo-based Eisai Co., Ltd. (Eisai), announced that the humanized amyloid-beta monoclonal antibody Leqembi was granted a Marketing Authorization by the Medicines and Healthcare products Regulatory Agency in Great Britain.

The same month, Biogen, along with Eisai, announced that the Ministry of Health and Prevention in the United Arab Emirates approved the humanized anti-soluble aggregated amyloid-beta monoclonal antibody LEQEMBI (lecanemab) for the treatment of AD. Per BIIB, treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease (collectively referred to as early AD), the population in which treatment was initiated in clinical trials.

Intra-Cellular Therapies, Inc. is another key player in the AD space. In August, ITCI reported its second-quarter 2024 results, wherein management confirmed the commencement of patient enrollment in ITI-1284 Phase 2 Studies in Generalized Anxiety Disorder (GAD) and Psychosis associated with AD. Intra-Cellular Therapies’ management also stated that it anticipates commencing patient enrollment in the Phase 2 program in agitation associated with AD soon.

In May, ITCI reported its first-quarter 2024 results, wherein management confirmed the initiation of the Phase 2 programs evaluating ITI-1284 in GAD, psychosis in AD, and agitation in AD and anticipated commencing patient enrollment in the second quarter of 2024.


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