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Lumipulse G β-Amyloid Ratio test has breakthrough device designation

March 2019—Fujirebio Diagnostics received on Feb. 1 breakthrough device designation from the FDA Center for Devices and Radiological Health for its Lumipulse G β-Amyloid Ratio (1-42/1-40) quantitative in vitro diagnostic test.

The test uses measurable β-amyloid 1-42 and β-amyloid 1-40 concentrations found in human cerebral spinal fluid and combines those concentrations into a numerical ratio of β-amyloid 1-42/β-amyloid 1-40 to estimate the presence of β-amyloid neuritic plaque pathology in the brain.

The Lumipulse G β-Amyloid Ratio (1-42/1-40) combines the results of Lumipulse G β-amyloid 1-42 and β-amyloid 1-40 using the Lumipulse G System. The ratio results are intended to aid in assessing adult patients, ages 50 and over, who present with cognitive impairment and are being evaluated for Alzheimer’s disease and other causes of cognitive decline. The results must be interpreted in conjunction with other diagnostic tools such as neurological examination.

A negative Lumipulse G β-Amyloid Ratio (1-42/1-40) result is consistent with a negative amyloid PET scan result. A positive Lumipulse G β-Amyloid Ratio (1-42/1-40) result is consistent with a positive amyloid PET scan result. A positive result does not establish a diagnosis of AD or other cognitive disorder. This test is not intended as a screening or standalone diagnostic assay.

FDA grants de novo designation for AML/MDS FISH probes

Oxford Gene Technology has been granted de novo classification by the FDA for eight Cytocell Aquarius Hematology FISH probes for acute myeloid leukemia and myelodysplastic syndromes.

The probes form the largest FDA-cleared in vitro diagnostic FISH probe range for AML and MDS on the market, according to OGT, and will address a substantial proportion of hematological FISH testing. The cleared probes will reduce the level of validation required in laboratories, OGT says, and provide accurate, easy-to-interpret detection of chromosomal rearrangements reported in AML and MDS.

The FDA-cleared Cytocell Aquarius FISH probes are as follows:

• AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion
• CBFβ (CBFB)/MYH11 Translocation, Dual Fusion
• Del(5q) Deletion
• Del(7q) Deletion
• Del(20q) Deletion
• EVI1 (MECOM) Breakapart
• MLL (KMT2A) Breakapart
• P53 (TP53) Deletion

FDA clears digital PCR system and test for monitoring CML treatment

Bio-Rad Laboratories’ QXDx AutoDG ddPCR System, which uses Bio-Rad’s Droplet Digital PCR technology, and the QXDx BCR-ABL %IS Kit are the first digital PCR products to be cleared by the Food and Drug Administration. Bio-Rad says its system and kit, when used together, can precisely and reproducibly monitor molecular response to treatment in patients with chronic myeloid leukemia.

The QXDx AutoDG ddPCR System is designed to be flexible, allowing users to run on the platform either FDA-cleared in vitro diagnostic tests or lab-developed tests.

Thermo Fisher signs agreement to sell AP business

Thermo Fisher Scientific has signed a definitive agreement to sell its anatomic pathology business to PHC Holdings for about $1.14 billion in cash.

The anatomic pathology business generates about $350 million in annual revenue and is part of Thermo Fisher’s Specialty Diagnostics Segment. Thermo Fisher expects to close the transaction in the second quarter of this year.

In vivo, ex vivo microscopy section in Archives

The first of two special sections on in vivo and ex vivo microscopy is published in this month’s issue of Archives of Pathology & Laboratory Medicine.

Dr. Hariri