NEW YORK – 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.
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.
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.
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 GenomeWeb.