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In Brief This Week: PerkinElmer, Fujirebio Europe, Exagen, Genetic Technologies, and More

NEW YORK – PerkinElmer said this week that GenWorks Health will exclusively distribute its newborn and prenatal screening portfolio in India. Terms of the deal were not disclosed. The deal will improve access to reproductive health solutions, especially in private hospitals and clinics, PerkinElmer said.

Separately, the Waltham, Massachusetts-based company also said this week that its board has declared a regular quarterly dividend of $.07 per share of common stock, payable on Feb. 11, 2022, to all shareholders of record at the end of business on Jan. 21, 2022.

Fujirebio Europe announced this week that it has entered an agreement with the Diagnostics Accelerator Initiative of the Alzheimer’s Drug Discovery Foundation to accelerate the development of a plasma pTau181 detection assay on the Lumipulse G immunoassay system. PTau is a fluid biomarker linked to the diagnosis of Alzheimer’s disease. Financial and other terms of the deal were not disclosed.

Exagen announced this week that its flagship Avise CTD and Avise Lupus tests are now contracted covered services with Inland Empire Health Plan, making Avise diagnostic testing available to more than 1.4 million members as an in-network benefit.

Genetic Technologies this week announced results for its first quarter of fiscal year 2022, reporting cash receipts of A$850,000 ($625,430).

The Melbourne, Australia-based firm said that during the quarter ended Sept. 30, it acquired and integrated EasyDNA for US$4 million, and the new company became a primary channel for an increase in cash receipts during the quarter.

A cash balance of A$15.7 million at the end of the quarter provides it with 24 months of runway post integration of EasyDNA, including revenue contributed by EasyDNA, the firm said.

During the recently completed quarter, net cash used for operations was A$1.9 million and was due mainly to an increase in R&D and operating expenses as the firm executes on its commercialization strategy.

Genetic Technologies added that it has submitted a validation package to the Australian National Association of Testing Authorities for its Genetype MultiTest assay, a predictive panel risk test that the firm said covers common cancers that account for approximately 70 percent of annual morbidities. A phase one launch will include breast cancer, colorectal cancer, prostate cancer, ovarian cancer, coronary artery disease, and type 2 diabetes.

Anitoa Systems said this week that its Maverick line of qPCR instruments has been registered and listed with the US Food and Drug Administration as a Class II 510(k)-exempt medical device. According to the company, the platform can provide a test result in about 45 minutes using standard RT-PCR chemistry. It is available in 4-, 6-, and 16-well formats, all of which feature a proprietary low-light sensitive, complementary metal-oxide-semiconductor four-channel fluorescence optics system for multiplexed DNA detection, as well as cloud-based software for data storage and retrieval. "We are excited to offer laboratories throughout North America and other international markets a portable solution for rapid and on-site nucleic acid tests to help combat diseases such as COVID-19," Anitoa Systems CEO Zhimin Ding said in a statement.

Montreal-based Optina this week announced it has raised C$24.8 million ($20.1 million) in a Series A financing round. The financing will primarily support a pivotal study for its Awair cerebral amyloid status test for suspected Alzheimer's disease and the development of a platform for the early detection of systemic diseases, the firm said.

Centogene said this week that the first patient has been enrolled in EFRONT, an observational study to understand the prevalence of genetic mutations in patients with frontotemporal dementia. The study, which is supported by Alector, uses Centogene's rare disease biobank and database, along with its network of physicians, and plans to enroll more than 3,000 FTD patients at centers in Belgium, Germany, Greece, Italy, Portugal, Spain, and Turkey. Centogene will provide genetic testing for the study, and patients with mutations in progranulin will have the option to enroll in Alector's Phase III INFRONT-3 clinical trial of AL001, an investigational drug designed to increase progranulin levels.

Avalon Healthcare Solutions this week said it began providing laboratory benefits management services to Utah-based SelectHealth, a nonprofit health plan serving more than 950,000 membersTampa, Florida-based Avalon said it and SelectHealth are focused on using the latest technology, evidence-based medicine, and provider education to ensure high-quality, cost-effective laboratory services for SelectHealth members.

Caris Life Sciences said this week that the Caris Precision Oncology Alliance and NCI's Center for Cancer Research will collaborate on precision medicine research initiatives. As part of the collaboration, Caris will make its suite of comprehensive molecular profiling offerings available to NCI researchers, and will link molecular testing results into an electronic medical records database to create a more complete dataset of combined patient outcomes and molecular information. Further, Caris said, joining the POA network will enable the NCI faculty and researchers to conduct clinical and translational research collaboratively across the alliance, to participate in all ongoing research activities across POA tumor groups, and to generate and publish clinical outcomes data that impacts cancer care across the US. 

The POA currently includes 55 cancer centers and academic institutions, including 24 NCI-designated cancer centers.

MDxHealth said this week that it is launching a registered initial public offering of 3,750,000 American Depositary Shares, each representing 10 of the company’s ordinary shares, with no nominal value per share. The company filed for an IPO of ADSs with a proposed maximum aggregate offering price of $30 million earlier this month.  In connection with the offering, MDxHealth intends to grant the underwriters a 30-day option to purchase additional ordinary shares, which may be in the form of ADSs, in an aggregate amount of up to 15 percent of the total number of ordinary shares offered in the IPO. 

MDxHealth’s ordinary shares are currently listed on Euronext Brussels under the symbol MDXH. The company has made an application to list the ADSs on the Nasdaq Capital Market under the same symbol. Piper Sandler and Oppenheimer are acting as lead bookrunning managers, BTIG is acting as a lead manager, and KBC Securities USA is acting as a co-manager for the offering. 

In a filing with the US Securities and Exchange Commission last week, Thermo Fisher Scientific closed a previously priced offering of $5.85 billion aggregate principal amount of five types of senior notes. The company said it expects net proceeds from the sale of approximately $5.82 billion, after deducting underwriting discounts and estimated offering expenses.

Thermo Fisher said it intends to use the net proceeds to pay a portion of the cash consideration for its pending acquisition of PPD. The company agreed in April to pay $17.4 billion for the clinical research services provider, plus the assumption of approximately $3.5 billion of net debt.

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.