NEW YORK – Roche subsidiary Foundation Medicine said this week that its FoundationOne Tracker test for circulating tumor DNA detection and molecular monitoring has received breakthrough device designation from the US Food and Drug Administration. The test uses optimized algorithms to identify patient-specific variants and a personalized assay design to detect ctDNA in plasma, the company said in a statement. The breakthrough device designation was granted for the assay’s use in the detection of molecular residual disease in early-stage cancer after curative therapy. The test, an RUO version of which launched in June 2021, can help guide further therapy decisions depending on MRD status and the risk of relapse. It was developed in collaboration with Natera and combines Foundation’s tissue-based comprehensive genomic profiling platform with Natera’s expertise in personalized ctDNA monitoring.
Seegene said this week that its fourth quarter 2021 revenues increased 34 percent year over year to ₩410 billion ($342 million), and that full-year revenues rose 22 percent to ₩1.37 trillion. The Seoul, South Korea-based company said sales were driven by growth in SARS-CoV-2 testing products as well as its broader molecular diagnostics portfolio. The firm spent ₩75 billion on research and development last year, three times more than in 2020, and doubled its headcount to approximately 1,100 employees.
Datar Cancer Genetics said this week that it has received breakthrough designation for its TriNetra-Prostate blood test for early-stage prostate cancer. The test detects prostate adenocarcinoma-specific circulating tumor cells and is indicated for men between the ages of 55 and 69 with serum PSA levels of 3 ng/ml or higher.
SQI Diagnostics said this week that it has completed the asset acquisition of Precision Biomonitoring's COVID-19 PCR testing business and its TripleLock molecular diagnostic testing technology for $6.8 million in cash and stock. The acquisition includes the Canadian distribution rights for Biomeme's SARS-CoV-2 Real-Time RT-PCR Test and Biomeme's Rapid Mobile Testing devices, including its Franklin portable test reader for human use.
Australian molecular diagnostics company Genetic Signatures said this week that its revenues for the first half of its fiscal year 2022 increased 16 percent year over year.
For the half year ended Dec. 31, the company posted revenues of A$21.9 million (US$15.8 million) compared to A$18.9 million for the prior-year period. Testing for SARS-CoV-2 accounted for the largest proportion of its sales, the firm said.
Genetic Signatures posted a profit of A$4.7 million, or A$3.20 per share, in the first half of FY 2022, compared to A$4.5 million, or $A3.09 per share, in the prior-year period.
As of Dec. 31, Genetic Signatures had a cash balance of A$37.5 million.
Among the highlights for the first half of fiscal 2022, the firm noted that Australia's Therapeutics Goods Administration registered its saliva-based protocol for collecting and testing patient samples for SARS-CoV-2 using the company's 3base EasyScreen SARS-CoV-2 Detection Kit.
Yourgene said this week that the UK Health Security Agency has approved the firm’s Clarigene SARS-CoV-2 test under regulations implemented last year. The test will be included in the register of the UK's coronavirus test device approvals amendment regulations, which require antigen-based and molecular COVID-19 tests to undergo a desktop review in order to be sold in the region.
In addition, Novacyt said this week that the UKHSA has approved the firm's PROmate COVID-19 2G Real-Time PCR test, which detects two SARS-CoV-2 targets within ORF1ab – nsp16 and an undisclosed gene. In November, Novacyt received UKHSA approval for its Genesig COVID-19 Real-Time PCR test, which targets one gene within ORF1ab.
Dante Labs said this week that its Dante Labs Sequencing Center in Dubai, United Arab Emirates, was licensed as an authorized medical laboratory for genomics last month. The lab is now authorized to operate in clinical cytogenetics, clinical pathology, laboratory-allied healthcare, clinical genetics, cytogenetics, and medical genetics.
Biosample collection firm Mawi DNA Technologies said this week that it has received two ISO certifications, ISO 9001:2015 Quality Management Systems and ISO 13485:2016 Medical Devices Quality Management Systems certification. These ensure that Mawi meets the requirements of the US Food and Drug Administration, according to the firm, and they are the first step toward complying with European regulatory standards for obtaining a CE mark.
ProPhase Labs of Garden City, New York, said this week that its board of directors has declared a special cash dividend in the amount of $.30 per share of the firm’s common stock. The dividend is payable on March 10 to stockholders of record as of March 1.
Abbott said this week that its board has declared a quarterly common dividend of $.47 per share, payable on May 16 to shareholders of record at the close of business on April 15.
Agilent Technologies this week announced a quarterly dividend of $.21 per share, payable on April 27 to shareholders of record at the close of business on April 5.
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.