NEW YORK — Danaher subsidiary Beckman Coulter Diagnostics announced this week that its Access p-Tau217/β-Amyloid 1-42 Plasma Ratio blood test has received breakthrough device designation from the US Food and Drug Administration. The test is intended to help clinicians identify patients who have amyloid pathology associated with Alzheimer's disease. The assay measures the ratio of phosphorylated tau protein (p-tau 217) to βAmyloid 1-42, two biomarkers associated with the neurodegenerative processes of Alzheimer's disease.
In 2023, Beckman Coulter announced a partnership with Fujirebio to develop blood-based immunoassays for Alzheimer's.
Guardant Health has inked an agreement with the Abu Dhabi Public Health Centre (ADPHC) to introduce a noninvasive blood-based screening program for colorectal cancer using Guardant’s Shield test, a methylation-based assay designed to detect cancer-associated signals in cell-free DNA that circulates in the blood. Hikma Pharmaceuticals, a regional partner for Guardant in the Middle East and North Africa, set up the partnership. The M42 healthcare system, a collection of advanced health facilities headquartered in Abu Dhabi, will serve as its administrator.
Under the agreement, Shield testing will be provided as part of the ADPHC’s IFHAS comprehensive health screening program and will be available at healthcare facilities across Abu Dhabi, Al Ain, and the Al Dhafra region. The partners aim to screen approximately 10,000 individuals in the program's first year and expect the availability of blood-based screening to help resolve low adherence rates for existing recommended screening tools like colonoscopy. Financial terms of the deal were not disclosed.
Quest Diagnostics said this week it has completed its previously announced acquisition of select assets of Cleveland-based University Hospitals’ outreach lab services business. The deal was originally announced in August.
Cancer early detection company Mainz Biomed said this week that on Jan. 23 it received notice from the Nasdaq stock market confirming that it has regained compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market. The company had previously received confirmation that it had regained compliance with Nasdaq's minimum bid price requirement. Mainz said it is now in full compliance with all Nasdaq continued listing requirements and will continue to be listed and traded on the Nasdaq Capital Market.
Diasorin said this week that the company's shareholders will vote Feb. 28 on a proposal to increase the voting rights of long-term shareholders. The proposed bylaws change would let shareholders accumulate up to 10 votes per share whereas shareholders today can accrue only double voting rights. If the amendment is approved, shareholders who already have two votes per share as of the effective date would accrue an additional vote per share each year to a maximum of 10 votes.
Akoya Biosciences said this week that it has selected Argonaut Manufacturing Services as the manufacturing partner for the company's IVD assays currently in development. The agreement, which builds on years of collaboration between the companies, aims to deliver companion diagnostics assays using Akoya's PhenoImager platform and spatial phenotyping technology, the company said.
Australian molecular diagnostics firm Genetic Signatures said this week that its revenues for the second quarter of its fiscal year 2025 were up 190 percent year over year. The company posted Q2 revenue of A$3.8 million ($2.4 million), up from A$2.0 million in Q2 2024. The company said the increase was driven largely by strong sales of its respiratory testing products in Australia as well as implementation of its EasyScreen Enteric Detection Kits for infection control in UK hospitals. As of Dec. 31, the company had A$40.8 million in cash, which includes A$5.1 million received under the Australian Research and Development Tax Incentive.
Swedish in vitro diagnostics company Devyser said this week that it has secured a tender for its Devyser CFTR next-generation sequencing cystic fibrosis test with Italian hospital Policlinico di Bari for five years with an estimated total order value of up to SEK 5.4 million (about $500,000). Devyser CFTR is a CE IVD-marked test that captures all clinically relevant cystic fibrosis gene mutations in a single assay to confirm a cystic fibrosis diagnosis and to screen for genetic variants in newborns and adults.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.