NEW YORK – Centogene this week reported €10.3 million ($10.4 million) in revenues for the first quarter of 2022, up 3 percent from €10.0 million in the year-ago quarter. Diagnostics revenues rose 11 percent to €7.1 million from €6.4 million the previous year, driven by an 18 percent increase in revenues from whole-exome and whole-genome sequencing. Pharmaceutical revenues dropped 10 percent to €3.2 million from €3.6 million in Q1 of 2021. Revenues from COVID-19 testing, which was phased out in Q1 of this year, dropped to €19.5 million from €55.0 million a year ago. Centogene recorded a net loss of €6.4 million for the quarter. As of March 31, the firm held €42.7 million in cash and cash equivalents.
T2 Biosystems said this week that it has received breakthrough device designation from the US Food and Drug Administration for its T2Lyme panel. The molecular diagnostic test detects Borrelia burgdorferi, Borrelia afzelii, and Borrelia garinii, which cause Lyme disease, directly from blood and runs on the firm’s T2Dx instrument. T2 Biosystems has also received a patent from the US Patent and Trademark Office for the assay.
Laboratory Corporation of America declared a cash dividend of $.72 per share of its common stock this week. The dividend will be payable on Sept. 9 to stockholders of record as of the close of business on Aug. 18.
Novacyt said this week that its Exsig COVID-19 Direct Real-Time PCR test has been approved under the UK Health Security Agency’s Medical Devices Coronavirus Test Device Approvals (CTDA) Amendment Regulations 2021. The test detects a target within ORF1ab and removes the need for extraction solutions, the firm said in a statement. It is also designed for use on an open platform, allowing it to run on Novacyt’s instruments or other validated systems. The company has received CTDA approval for four other COVID-19 tests and said it is awaiting approval on three other COVID-19 tests and one multiplex test.
Multi-state health system Mercy said this week that it has partnered with Grail to make the firm's cancer early detection blood test, Galleri, available to patients across its centers in the southern and southwestern US, joining several other health systems and managed care organizations.
The firm stressed that Galleri — a methylation-based assay designed to detect epigenetic patterns in circulating cell-free DNA that are associated with more than 50 types of cancer — is recommended specifically for adults with an elevated risk for cancer and available by prescription only. Customers will have to pay out of pocket for the test, which is not yet covered by insurance, but Mercy said it will "work with patients who qualify for but are unable to pay the total cost of the test." Interested patients can contact Mercy to see if they are eligible and connect with a "care navigator" to aid them in the test ordering process.
Selux Diagnostics said this week that it has received an additional $8.0 million milestone payment from the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA). The new funding was received as part of the firm’s $60.8 million BARDA contract granted in 2018 and will be used to advance development of the firm’s rapid antibiotic susceptibility testing solutions, including its Next Generation Phenotyping platform, which provides results for antimicrobial therapy within 24 hours.
Canadian liquid biopsy firm BioMark Diagnostics this week reported revenues of C$43,933 (US$48,000) for its fiscal year ended March 31 compared to no revenues in the prior year. The Vancouver, British Columbia-based company said the revenues were derived from its wholly owned subsidiary BioMark Diagnostic Solutions (BDS), which entered into research and collaboration agreements with various biotech companies during the year. As of March 31, BioMark had cash and cash equivalents totaling C$382,711 compared to C$877,678 the year before. BioMark recently closed a non-brokered private share placement, netting C$1.3 million to help accelerate the commercialization of its lung cancer detection technology. In addition, the company secured a non-dilutive line of credit up to C$235,000 through BDS. The firm intends to use these funds to seek lab accreditation, perform an assay validation and verification study, participate in a large-scale lung cancer screening program in Quebec, and perform business development activities in the US.
Genetic Technologies of Australia said this week that it has completed the previously announced acquisition of direct-to-consumer firm AffinityDNA, including its websites, brand identities, laboratory testing, and distribution agreements, for an undisclosed amount. Genetic Technologies said the acquisition provides an additional platform for its growth in the consumer genomics market. AffinityDNA sells lifestyle, health, and well-being genomic tests, as well as animal tests related to allergies.
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.