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In Brief This Week: Meridian Bioscience, Abbott, Danaher, DermTech, More

NEW YORK – Meridian Bioscience this week reported its fiscal Q1 financial results in a 10-Q document filed with the US Securities and Exchange Commission. Revenues for the quarter were $56.9 million, down 36 percent from $88.3 million in the same quarter of 2022. Diagnostics segment revenues increased 19 percent to $39.4 million from $33.2 million in the previous quarter, while life sciences revenues declined 68 percent to $17.6 million. The firm reported a net loss of $29.8 million, or $.68 per share, compared to a profit of $15.3 million, or $.35 per share, in Q1 2022. Meridian ended the quarter with $74.1 million in cash and cash equivalents. 

SD Biosensor and SJL Partners’ acquisition of Meridian was completed last month. 

Abbott announced this week that it will acquire medical device company Cardiovascular Systems for approximately $890 million. Cardiovascular Systems offers an atherectomy system to treat peripheral and coronary artery disease and is developing complementary vascular intervention devices. The deal is expected to be neutral to Abbott’s previously announced 2023 earnings per share guidance, it said in a statement. JP Morgan Securities is serving as financial adviser to Cardiovascular Systems. 

Danaher announced this week that the spinoff of its environmental and applied solutions business will be named Veralto. The company will include water quality and product identification subsidiaries Hach, ChemTreat, Trojan, OTT HydroMet, McCrometer, Videojet, Esko, X-Rite Pantone, and Linx. The headquarters will be established in Waltham, Massachusetts, and it is expected to trade on the New York Stock Exchange under the ticker symbol VLTO, Danaher said in a statement. The spinoff was announced in September and is expected to be completed in Q4 2023. 

DermTech said this week that the foundational assay of its DermTech Melanoma Test is now available to more than 9 million clients of the Veterans Health Administration because of a favorable coverage recommendation by the US General Services Administration. The California-based diagnostic firm's assay is used to check skin lesions, moles, and dark skin spots for melanoma. The RT-PCR assay identifies expression of the LINC00518 and PRAME genes, and it can include an add-on sequencing-based assay to identify the presence of TERT promotor mutations. The firm said its testing platform detects melanoma with a greater than 99 percent negative predictive value. 

The Rockefeller Foundation said recently that the Centre for Cellular and Molecular Platforms has launched the National Diagnostics Catapult in New Delhi (C-CAMP InDx 2.0). The program, which is anchored by C-CAMP, seeks to boost India's preparedness for current and future pandemics. C-CAMP InDx 2.0 builds on Indigenization of Diagnostics (CCAMP-InDx), an India-wide COVID-19 diagnostics platform launched in July 2020, which has achieved more than 1 million indigenous RT-PCR kits for SARS-CoV-2 per day while building the capacity of more than 200 indigenous ministry of micro, small, and medium enterprises and academic labs in India. 

SQI Diagnostics last week said it posted an 800 percent increase in revenue in the fiscal year ended Sept. 30, bringing in $8.1 million in fiscal year 2022, up from $900,000 in the fiscal year prior. The firm posted a loss of $18.5 million for the year, or $.05 per share, compared to a loss of $10.5 million, or $.03 per share, the prior fiscal year. The firm attributed the rise in revenue to its acquisition of Precision Biomonitoring's PCR testing business during Q2 2022. SQI CEO Andrew Morris said in a statement the firm transitioned last year from an R&D organization to a commercial company. 

SQI also reported results for Q4 2022, when it had sales of $1.2 million, up from $100,000 in the year-ago quarter. The firm posted a loss of $7.8 million, or $.02 per share, for the quarter, compared to a loss of $2.8 million, or $.01 per share, in the prior-year quarter. The firm ended the quarter and year with $1.3 million in cash and cash equivalents. 

Pillar Biosciences said this week that it has received accreditation from the College of American Pathologists (CAP) for its CLIA-certified reference lab. Natick, Massachusetts-based Pillar offers next-generation sequencing-based assays to assist with tumor profiling, therapy selection, and recurrence monitoring for cancer patients. Pillar CEO Randy Pritchard noted that CAP accreditation is an "important milestone in our company's mission to collaborate with biopharma to develop enabling technologies for cutting-edge therapies and deliver NGS solutions that drive actionable, accessible results to everyone, everywhere." 

DCN Dx announced this week a subcontract with Mapp Biopharmaceutical to develop, optimize, and deploy a digitized lateral flow assay to detect circulating Sudan ebolavirus antigen for real-time use in nonclinical studies. The studies will be performed in biosafety level 4 containment laboratories. Mapp Biopharmaceutical recently received a $109.8 million contract from the Administration for Strategic Preparedness and Response to develop and potentially purchase a monoclonal antibody therapeutic for treating patients with SUDV. The amount of the subcontract was not disclosed. 

ProtonDx said this week that its Dragonfly Respiratory Panel has been validated and approved for use in the UK under the UK Health Security Agency's Medical Devices (Coronavirus Test Device Approvals) Regulations 2021. The test is a rapid, point-of-care molecular test that identifies influenza A/B, respiratory syncytial virus, human rhinovirus, and SARS-CoV-2 in less than 30 minutes, the company said. The test was CE-IVD marked last year. 

BioMark Diagnostics said this week that its subsidiary BioMark Diagnostic Solutions has received up to C$185,900 (US$138,606) in funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP), which the firm will put toward researching and developing a liquid biopsy-based assay to measure drug metabolites for cancer treatment monitoring. BioMark also said it is receiving an additional C$13,275 (US$9,898) from Global Affairs Canada under the CanExport Innovation Program. 

Molecular diagnostics firm AusDiagnostics said last week that it inked a deal to manufacture OrthoDx-branded SynvIchor products to differentiate between infection and inflammation in orthopedics. The Australian firms said that, under the deal, AusDiagnostics will make the products for worldwide supply under an original equipment manufacturing agreement. Financial and other terms of the agreement were not disclosed. 

Biovica International said this week that its test laboratory in San Diego has received CLIA certification, allowing the firm to begin commercial sales of DiviTum TKa, a cancer cell proliferation monitoring assay, as a laboratory-developed test in the US. The company's first planned clinical application for the assay is in treatment monitoring of patients with metastatic breast cancer. 

DiviTum TKa, which has US Food and Drug Administration 510(k) clearance and a European CE mark, measures cell proliferation by detecting TKa (the activity of the enzyme thymidine kinase) in the bloodstream. According to Biovica, the test has proved itself as a correlate of therapy effectiveness in several clinical trials. 

NGeneBio said this week that it has launched a next-generation sequencing-based breast cancer diagnostic service in Thailand through MP Group, a consignment inspection agency and distributor of medical devices. The lab is offering NGeneBio's BRCaccuTest Plus to hospitals, government-affiliated medical institutions, health centers, and the general public. 

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.