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Roche Alzheimer’s Early Detection Tests Get FDA Green Light

by | Dec 22, 2022 | Diagnostic Testing and Emerging Technologies, FDA-dtet

In this month’s diagnostics pipeline report, Roche gets clearance for two new Alzheimer’s early detection tests.

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.


  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


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)

Diazyme LaboratoriesEUA for Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit
Roche510(k) clearance for Elecsys Beta-Amyloid (1-42) CSF II assay measuring beta-amyloid biomarkers for Alzheimer’s disease in patients 55 and older being evaluated for the disease
Roche510(k) clearance for Elecsys Phospho-Tau (181P) CSF assay measuring tau protein biomarkers for Alzheimer’s disease in patients 55 and older being evaluated for the disease
RocheClearance for Ventana FOLR1 RxDx test as companion diagnostic for ImmunoGen's Elahere (mirvetuximab soravtansine-gynx)
RocheEUA for molecular monkeypox RT-PCR test
Virax BiolabsEUA for Over-the-Counter COVID-19 Rapid Antigen Test
HemoSonics510(k) clearance for QStat Cartridge assay to provide point-of-care hemostasis data during trauma and liver transplantation procedures
Lucira HealthEUA for molecular COVID-19 and Flu Test for use at the point of care developed in collaboration with the US National Institutes of Health's Independent Test Assessment program
Azure BiotechEUA for Fastep COVID-19 Antigen Home Test
CorDxEUA for CorDx COVID-19 Ag Test at-home antigen assay
Premier Medical Laboratory ServicesEUA for Diversified Medical Healthcare SARS-CoV-2 Assay real-time RT-PCR-based test done on nasal swab specimens collected at home using the DoINeedaCOVID19Test.com Self-Collection Kit
Beijing Hotgen BiotechEUA for Hotgen COVID-19 Antigen Home Test
AEYE Health510(k) clearance for AEYE-DS system that uses AI to diagnose diabetic retinopathy from retinal images
ANP TechnologiesEUA for NIDS COVID-19 Antigen Home Test
ProciseDxClearance for ProciseDx instrument and C reactive Protein (CRP) test for quantitative detection of CRP levels in patient serum
PerkinElmer510(k) and De Novo clearance for Eonis SCID-SMA assay kit for simultaneous detection of spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID) in newborns
Baebies510(k) clearance for rapid point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency
RapidAIClearance for updated version of Rapid ICH product, AI-outfitted software that quickly detects or rules out acute brain hemorrhage on unenhanced CT
Nanobiosym Precision Testing ServicesEUA for Nano Test for COVID-19, RT-PCR assay
DiaSorin510(k) clearance for Simplexa Congenital CMV Direct kit for detection of cytomegalovirus (CMV) DNA, first FDA-cleared product for diagnosing congenital CMV from both saliva swab and urine specimens
Rize LaboratoryEUA for SARS nCoV-2019 Multiplexed Assay

Global Report

Europe: New CE Markings in Europe

SeekInSeekInCure cancer recurrence monitoring test
LunitLunit INSIGHT AI solutions for radiology
SIME DiagnosticsClinical AI Platform for rapid prediction of severe respiratory disease

Other international clearances announced during the period:

LunitUKLunit INSIGHT AI solutions for radiology
NovacytUKGenesig COVID-19 3G Real-Time PCR test
See-Mode TechnologiesCanadaMedical AI software to detect lesions in ultrasound images and assign feature classification to each