December 2022 FDA Watch: More Approvals in US than EU

Regulators Approve 3 Breakthrough Newborn Screening Products in US and Europe

Higher volume of FDA clearances of new laboratory test and diagnostics products in the US made up for the relatively low number of approvals in the EU, which has now transitioned to its new and somewhat controversial In Vitro Diagnostic Regulation (IVDR) regime. One of the biggest stories of November was the three novel newborn screening products to secure first of their kind regulatory approval in Europe or the US. Here’s a quick briefing on each newborn testing product.

AI Severe Respiratory Disease Platform (SIME Diagnostics)

On Nov. 14, SIME Diagnostics announced it received CE-IVD accreditation in Europe for what it claims is the world’s first clinical AI platform for rapid prediction of severe respiratory disease. The device uses proprietary algorithms to analyze thousands of unique datapoints associated with severe respiratory disease in less than 15 minutes. The UK firm, which produces point-of-care respiratory diagnostics for the ICU, has launched a pilot called RDS Predict to rapidly identify which newborns are likely to develop respiratory distress syndrome (RDS), the leading cause of morbidity and mortality in babies born prematurely.¹

Eonis SCID-SMA Simultaneous Detection Kit for Newborn Screening (PerkinElmer)

PerkinElmer secured FDA clearance to market an assay that simultaneously detects spinal muscular atrophy (SMA) and severe combined immunodeficiency (SCID). The Eonis SCID-SMA assay kit is the first SMA screening assay for newborns to receive FDA marketing authorization, according to the company. The kit had to travel two pathways to reach the US market, with the SMA portion of the test receiving De Novo and the SCID portion getting 510(k) clearance from the agency. The kit is designed for use with dried blood spot samples on PerkinElmer’s Eonis real-time PCR instrument.²

Congenital CMV Kit for Saliva and Urine Samples (DiaSorin)

On Nov. 9, DiaSorin announced that its Simplexa Congenital CMV Direct kit for detection of cytomegalovirus (CMV) had received 510(k) clearance from the FDA. Congenital CMV is a potentially fatal condition that can occur when a mother passes the virus to her child. Run on DiaSorin’s Liaison MDx platform, the Simplexa assay detects DNA from the virus in newborns up to 21 days old. It’s the first product cleared by the FDA for diagnosing congenital CMV from both saliva swab and urine specimens, according to the Italian testing giant. The kit received CE clearance for marketing in Europe in 2020.³

References:

1. https://www.prnewswire.co.uk/news-releases/sime-ai-device-that-predicts-acute-respiratory-disease-receives-ce-mark---changing-the-standard-of-care-for-millions-of-babies-worldwide-301675729.html
2. https://www.businesswire.com/news/home/20221114005255/en/PerkinElmer-Announces-its-EONIS-SCID-SMA-Kit-is-First-to-Receive-Marketing-Authorization-by-U.S.-FDA-for-SMA-Screening-in-Newborns
3. https://diasoringroup.com/sites/diasorincorp/files/allegati_pressrel/diasorin_simplexar_ccmv_direct_assay_received_u.s._fda_510k_clearance.pdf

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Here are some of the key new FDA EUAs and clearances that were announced in November 2022:

New FDA Approvals & Emergency Use Authorizations (EUAs)

Manufacturer(s)	Product
Beijing Hotgen Biotech	EUA for Hotgen COVID-19 Antigen Home Test
AEYE Health	510(k) clearance for AEYE-DS system that uses AI to diagnose diabetic retinopathy from retinal images
ANP Technologies	EUA for NIDS COVID-19 Antigen Home Test
ProciseDx	Clearance for ProciseDx instrument and C reactive Protein (CRP) test for quantitative detection of CRP levels in patient serum
PerkinElmer	510(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
Baebies	510(k) clearance for rapid point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency
RapidAI	Clearance 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 Services	EUA for Nano Test for COVID-19, RT-PCR assay
DiaSorin	510(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 Laboratory	EUA for SARS nCoV-2019 Multiplexed Assay
Roche	Clearance for Ventana FOLR1 RxDx test as companion diagnostic for ImmunoGen's Elahere (mirvetuximab soravtansine-gynx)
Roche	EUA for molecular monkeypox RT-PCR test
Roche	Premarket approval for Cobas 5800 compact PCR molecular diagnostics system and assay to detect HIV-1
Roche	510(k) clearance for its Cobas SARS-CoV-2 Qualitative PCR test which had previously received only EUA clearance
Grifols	Clearance for direct-to-consumer use of AlphaID, cheek swab-based test for alpha1-antitrypsin (AAT) deficiency
OraSure Technologies	Clearance for over-the-counter use of ORAcollect Dx collection device to support screening using Grifols' AlphaID test for AAT deficiency
23andMe	510(k) clearance for pharmacogenetics report for SLCO1B1 that includes interpretive drug information for simvastatin
BioMérieux	510(k) clearance for Vitek 2 AST-Gram Positive Cefoxitin Screen, fully automated short-term incubation cycle antimicrobial susceptibility test for use on firm's Vitek 2 and Vitek 2 Compact systems
BioFire Diagnostics (BioMérieux subsidiary)	Clearance for BioFire Global Fever Panel, multiplex assay designed for use with BioFire FilmArray 2.0 and FilmArray Torch PCR system
Abbott	Clearance for Architect CMV IgG test, a chemiluminescent microparticle immunoassay to measure IgG antibodies
Helena Laboratories	Clearance for Spife A1AT Kit, an alpha-1 antitrypsin immunological test
Instrumentation Laboratory (Werfen subsidiary)	Clearance for HemosIL Liquid Anti-Xa test, automated chromogenic heparin assay with synthetic chromogenic substrate and Factor Xa inactivation
CoaguSense	Clearance for Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self Testing
Nova Biomedical	510(k) clearance for Nova Primary Glucose Analyzer System, enzymatic blood-glucose concentration test system
OK BioTech	510(k) clearance for SuperCheck Pro Blood Glucose Monitoring System

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New CE Markings in Europe

Manufacturer(s)	Product(s)
SIME Diagnostics	Clinical AI Platform for rapid prediction of severe respiratory disease
Cepheid	Xpert Xpress GBS group B Streptococcus assay
FireGene	Monkeypox virus nucleic acid test kit

Other international clearances announced during the period:

Manufacturer(s)	Country(ies)	Product(s)
See-Mode Technologies	Canada	Medical AI software to detect lesions in ultrasound images and assign feature classification to each
Novacyt	UK	Winterplex 3G real-time PCR assay for SARS-CoV-2, influenzas A and B, and respiratory syncytial virus