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In Brief This Week: Quest Diagnostics, Beckman Coulter, Thermo Fisher Scientific, Diadem, and More

NEW YORK – Quest Diagnostics said this week that it has entered a definitive deal to acquire patient engagement firm Pack Health. Terms of the all-cash agreement were not disclosed. Based in Birmingham, Alabama, Pack Health aids individuals engage in better behaviors to improve disease outcomes. It specializes in addressing chronic conditions and comorbidities that are influenced by lifestyle choices, mental health, access to care, and social determinants of health. Among its clients are health plans and pharmaceutical companies, and its services include medication adherence coaching for pharma clients, patient education programs, diet and exercise coaching, and community resource outreach to address issues such as food insecurity and transportation access.

Beckman Coulter said this week that it has received an EU Quality Management System Certificate under the new In Vitro Diagnostic Medical Devices Regulation, currently set to take effect in May. The certificate covers more than 200 CE-IVD-marked flow cytometry reagents developed and manufactured at Beckman Coulter’s Marseilles, France-based facility. The Danaher subsidiary said that additional certifications are expected in the near future.

Diadem this week announced that the US Food and Drug Administration has granted breakthrough device designation for AlzoSure Predict, a blood-based biomarker prognostic assay designed to identify whether individuals over the age of 50 with signs of cognitive impairment will progress to Alzheimer's disease, up to six years before definitive symptoms appear.

Diadem said its application was supported by data from a 482-patient longitudinal study. Patients were 50 years or older at the start of the study and asymptomatic or at the early stages of Alzheimer's disease or other dementias. Study results were published in a MedRxiv preprint and have been submitted to a peer-reviewed journal. The second phase of the study, which includes biobank data on more than 1,000 additional patients from the US and Europe, is due for completion in coming months, the firm said.

The US Food and Drug Administration this week included all blood specimen collection tubes to its device shortage list. Previously, only sodium nitrate tubes were on the list. The agency said that the tubes, which have product codes GIM and JKA, are expected to remain in short supply through the end of 2022. The FDA has issued recommendations to healthcare and laboratory personnel to conserve supplies of the tubes.

Gravity Diagnostics will perform its 3-in-1 multiplex test for the diagnosis and differentiation of flu A/B, RSV, and COVID-19 in Kroger's 224 Little Clinics, the firms announced this week. The test uses a swab collection and leverages PCR technology, a Gravity Dx spokesperson said, adding that the firm submitted it for Emergency Use Authorization by the US Food and Drug Administration last August. Currently, the test is being offered as a laboratory-developed test.

Pathogenomix said this week that the US Food and Drug Administration has granted its Patho-Seq assay breakthrough device designation. The next-generation sequencing test is for the rapid detection and identification of bacteria involved in disease, including sepsis from whole-blood samples and bacterial meningitis from cerebrospinal fluid. Patho-Seq is based on a targeted 16S sequencing approach, the Santa Cruz, California-based company noted, adding that it collaborated with the Mayo Clinic to develop techniques and data that supported the application for breakthrough device designation.

CliniSys said this week that it has acquired Horizon Lab Systems and has combined with Sunquest Information Systems to create an organization dedicated to diagnostic and laboratory informatics. All three firms provide laboratory informatics solutions, including lab information management systems, or LIMS. CliniSys said the combined company will work to apply technologies such as advanced analytics, artificial intelligence, and machine learning to laboratory systems. Horizon Lab Systems has been providing cloud-based LIMS for a variety of markets, including clinical diagnostics.

Uniogen said this week it has emerged from a previously announced transaction to combine three Finnish diagnostic companies — Abacus Diagnostica, Kaivogen, and Labrox.

Abacus Diagnostica develops and produces molecular tests and rapid PCR test systems; Kaivogen is an immunoassay and antibody test specialist; and Labrox is a developer of laboratory instruments and diagnostic readers. Last September, the companies had announced their intention to merge into one firm, called Uniogen, that will integrate their respective technologies into a next-generation diagnostic instrument.

Genetic Technologies said this week that it ended the second quarter of its fiscal year 2022, which ended Dec. 31, with a cash balance of A$13.5 million (US$9.7 million). The Melbourne, Australia-based firm, which had announced the acquisition of direct-to-consumer molecular testing firm EasyDNA in July 2021, said total Q2 cash receipts from EasyDNA were A$1.8 million, in line with expectations.

DnaNudge said this week that it has integrated its COVID-19 PCR test, CovidNudge, with the Health Passport Worldwide digital health platform. Customers who received their test at a DAM Health clinic can now receive their result directly to their mobile device using Health Passport Worldwide's app. DAM Health recently partnered with DnaNudge to deploy the CovidNudge test across its UK clinics.

Yourgene Health said this week that Yourgene Health Canada, formerly known as Coastal Genomics, has launched an expanded facility in Vancouver, British Columbia. The Canadian branch, which Yourgene acquired in 2020, more than doubled its headcount last year, Yourgene said, and plans to add another six team members by April of this year.

Thermo Fisher Scientific said this week that it will redeem all of its 3.65 percent senior notes due 2025, with a $350 million aggregate principal amount, on Feb. 7. The company plans to fund the aggregate redemption price using cash on hand.

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.