More than six million Americans suffer from dementia related to Alzheimer’s, according to National Institutes of Health (NIH) and Mayo Clinic estimates. The key to effective treatment is to diagnose the disease early before it damages a significant enough number of brain cells to cause a patient to exhibit signs of impaired thinking and dementia. While positron emission tomography (PET) scans can effectively detect the amyloid plaques associated with Alzheimer’s, PET scans are expensive and may not identify whether a patient has Alzheimer’s specifically, or cognitive decline due to another cause.¹

The good news is the recent discovery of new biomarkers for the early onset of Alzheimer’s, namely elevated levels of plasma tau phosphorylated at threonine 217 (p-tau217). Studies suggest that these biomarkers can be effectively discovered via the use of blood-based testing. A notable study published in JAMA Neurology in November 2020 found that blood tests detecting abnormal tau metabolism in the brain could detect pathology earlier than PET scans in patients with preclinical Alzheimer’s disease.²

While blood-based Alzheimer’s early detection tests have been approved in Europe and other global markets, they were unable to get US FDA clearance until May 4, 2022, when the agency granted its first clearance for such a test, awarding De Novo clearance to Malvern, Pennsylvania-based Fujirebio Diagnostics’ Lumipulse G β-Amyloid Ratio (1-42/1-40) test for use in evaluating cognitively impaired people ages 55 and older for Alzheimer’s. The Lumipulse assay detects the presence of amyloid plaques by measuring the ratio of β-amyloid 1-42 and β-amyloid 1-40 in patient cerebrospinal fluid (CSF).³

Roche Leads the Way

Roche has also been a leading player in the development of Alzheimer’s early detection blood tests. On July 19, Roche’s Elecsys Amyloid Plasma Panel measuring the quantity of p-tau 181 and apolipoprotein e4 (ApoE4) in blood received breakthrough device designation from the FDA. In addition to speeding up Alzheimer’s diagnosis, the Elecsys Panel can help patients without Alzheimer’s avoid unnecessary, invasive, and expensive testing.⁴

On Dec. 8, Roche announced that two more of its Alzheimer’s Elecsys early detection tests received 510(k) clearance from the FDA. Both are CSF assays that run on the company’s Cobas fully automated immunoassay analyzer and target the newly discovered biomarkers that have become recognized as “hallmarks” of Alzheimer’s disease:

• The Elecsys Beta-Amyloid (1-42) CSF II assay, which measures beta-amyloid proteins; and
• The Elecsys Phospho-Tau (181P) CSF assay that measures tau proteins.

Both assays, which have already received CE marking in Europe and are registered in 45 countries globally, have also achieved 90 percent concordance with amyloid PET scan imaging, according to Roche. “The Elecsys AD CSF assays have the potential to guide more people with suspected Alzheimer's disease towards a diagnosis than ever before,” noted Roche Diagnostics CEO Thomas Schinecker in a statement.⁵

Pipeline Highlights

Other headlines in new laboratory test product approvals during the past month include the flurry of new Emergency Use Authorizations (EUAs) granted by the FDA for different point-of-care SARS-CoV-2 tests, including products from Lucira Health, Azure Biotech, CorDx, and Virax Biolabs.

Overseas, South Korean artificial intelligence (AI)-powered cancer diagnostics company Lunit made a splash by obtaining CE marking and United Kingdom (UK) clearance for a suite of AI radiology solutions marketed under the Lunit INSIGHT brand.⁶

November was also a hallmark month for novel newborn screening diagnostics, with three different products securing first of their kind approvals in the US or Europe, including:

• SIME Diagnostics’ Clinical AI Platform for rapid prediction of severe respiratory distress syndrome (RDS), the leading cause of morbidity and mortality in babies born prematurely, which received CE-IVD recognition in Europe;
• DiaSorin’s Simplexa Congenital CMV Direct kit for detection of cytomegalovirus (CMV), a potentially fatal condition that can occur when a mother passes the virus to her newborn child, which received 510(k) clearance from the FDA; and
• PerkinElmer’s Eonis SCID-SMA assay kit for simultaneous detection of spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns.

References:

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7856004/
2. https://jamanetwork.com/journals/jamaneurology/fullarticle/2772866
3. https://www.accessdata.fda.gov/cdrh_docs/pdf20/DEN200072.pdf
4. https://www.globenewswire.com/en/news-release/2022/07/19/2481449/0/en/Roche-s-Elecsys-Amyloid-Plasma-Panel-granted-FDA-Breakthrough-Device-Designation-to-enable-a-timely-diagnosis-of-Alzheimer-s-disease.html
5. https://diagnostics.roche.com/us/en/news-listing/2022/roche-alzheimers-disease-cerebrospinal-fluid-assays-receive-fda-clearance.html
6. https://www.prnewswire.com/news-releases/lunit-becomes-the-first-medical-software-company-in-asia-pacific-to-become-mdr-ce-and-ukca-certified-301683724.html

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Here are the key new laboratory testing and diagnostics products clearances that were announced from mid-November through mid-December 2022:

US Report: New FDA Approvals & Emergency Use Authorizations (EUAs)

Global Report

Europe: New CE Markings in Europe

Other international clearances announced during the period: