FDA approves FoundationOne Liquid CDx as companion diagnostic for Exkivity
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The US Food and Drug Administration (FDA) has granted approval for Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic for Takeda’s Exkivity (mobocertinib).
Exkivity already secured approval from the FDA for locally advanced or metastatic non-small cell lung cancer adult patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
FoundationOne Liquid CDx is claimed to be the only blood-based comprehensive genomic profiling test that received the US regulator’s approval for detecting EGFR exon 20 insertion mutations to identify suitable patients to treat with Exkivity.
This qualitative next-generation sequencing-based in vitro diagnostic test has the ability to analyse over 300 cancer-related genes for genomic alteration from a simple blood sample. It specifically analyses 324 genes by deploying circulating cell-free DNA.
The prescription use-only test received FDA approval to report short variants in 311 genes, as well as a companion diagnostic to detect patients who are expected to benefit from treatment with specific therapies.
Smith+Nephew receives contract for PICO wound therapy systems
Medical technology company Smith+Nephew has received an Innovative Technology contract from Vizient to supply its PICO single-use negative pressure wound therapy (sNPWT) systems.
PICO is a portable, easy-to-use, canister-free sNPWT system equipped with the Smith+Nephew soft port technology. The silicone-based, four-layer technology is designed to manage exudate from wounds by simultaneously evaporating and locking it away.
This removes extra moisture away from the wound and peri-wound area. Furthermore, the technology provides compression to the peri-wound area, potentially improving tissue perfusion.
Smith+Nephew NPWT vice-president and general manager Laura Ackerman said: “We are thrilled that our PICO System has been recognised by healthcare experts in receiving this distinguished Innovative Technology contract in the US.
“Surgical site complications continue to be costly events that plague our patients and healthcare systems. Our PICO technology has been shown to reduce the risk of SSIs across multiple specialities, improving patient care and helping get them home sooner.”
Hologic’s revenue falls to $1.02bn in Q2 2023
Global medical technology company Hologic reported a revenue of $1.02bn for the second quarter (Q2) ending 1 April 2023.
The company witnessed a 28.5% decline in revenue compared to $1.43bn during Q2 (three-month period ended 26 March) of fiscal 2022. The fall in revenue was mainly attributed to significantly lower sales of Covid-19 assays, compared to the same period a year ago.
The company’s total organic revenue, excluding Covid-19 revenue, grew by 20.2% during Q2 2023, compared to the prior year period.
Gross margin declined by 880 basis points (bps) to 57.1% from 65.9% in Q2 2022, while operating margin decreased by 1,490bps to 26.5%.
During the quarter, the diluted earnings per share (EPS) was $0.87 against $1.8 in the corresponding period in 2022.
FDA grants breakthrough device status to Singlera’s liquid biopsy assay
The US Food and Drug Administration (FDA) has granted breakthrough device designation to Singlera Genomics’ PDACatch liquid biopsy assay.
The new DNA methylation-based assay is intended to identify pancreatic adenocarcinoma in individuals at high disease risk.
PDACatch is based on the company’s MethylTitan platform, which deploys a library construction approach and methylation haplotypes to yield better conversion rates and cancer detection sensitivity.
Previously, the technology was shown to enable the early identification of five cancer types four years before conventional diagnosis.
The test is capable of identifying methylation patterns in circulating tumour DNA in blood, which originate from both early-stage pancreatic adenocarcinomas and precancerous pancreatic lesions such as intraductal papillary mucinous neoplasms and mucinous cystic neoplasms.
It will facilitate early detection and intervention for high-risk PDAC patients.
Siemens to distribute Scopio Labs’ digital imaging solutions platforms
Siemens Healthineers has reached an agreement with Scopio Labs for the distribution of the latter’s Scopio X100 and Scopio X100HT imaging platforms across the world.
Scopio X100 and Scopio X100HT provide full-field imaging and an artificial intelligence (AI)-powered decision support system with remote viewing capabilities.
These imaging platforms complement Siemens’ systems such as the Atellica HEMA 570 and Atellica HEMA 580 analysers.
Labs can use the combined platforms to achieve high-resolution, full-field viewing for peripheral blood specimens and AI-based morphological analysis with remote capabilities via the secure hospital network.
Scopio digital cell morphology platforms enable the examination of patient blood cell samples digitally and remotely, rather than on a microscope slide.
These platforms are designed for use in the central laboratory, alongside haematology analysers. A haematology analyser is used to run a sample from a patient.