NEW YORK – The US Food and Drug Administration this week granted breakthrough device designation to Quanterix's Simoa phospho-Tau 181 (pTau-181) blood test as an aid in the diagnostic evaluation of Alzheimer's disease. The Simoa pTau-181 test is a semiquantitative immunoassay intended for the measurement of pTau-181 concentration in human serum and plasma using the Quanterix HD-X immunoassay system. Proposed indications under the breakthrough device designation include use of the test results in adult patients 50 and older presenting with cognitive impairment who are being evaluated for AD and other causes of cognitive decline as an aid in diagnostic evaluation for AD. The test is not intended as a standalone diagnostic assay, and test results will be interpreted in conjunction with other diagnostic tools to establish a final clinical diagnosis, Quanterix said.
Cue Health and the National Basketball Association this week announced that the diagnostic company will be the league's Official Home and Point of Care Test for the 2021-22 season. The firm said it will provide all 30 NBA teams and the league's referees with the integrated Cue molecular diagnostic platform, which consists of the portable Cue Health Monitoring System and its COVID-19 tests.
The US Food and Drug Administration granted Emergency Use Authorization for Cue's COVID-19 test in March for at-home and over-the-counter use without a physician's supervision or a prescription.
Hologic said this week that it has signed a definitive agreement to acquire Louisville, Colorado-based Bolder Surgical, a provider of advanced energy vessel sealing surgical devices, for approximately $160 million. Hologic said the acquisition will broaden its growing surgical portfolio by adding Bolder’s advanced vessel sealing and dissection tools that are used in laparoscopic procedures.
The announcement comes in the wake of three molecular-diagnostic company acquisitions by the Marlborough, Massachusetts-based firm earlier this year.
Interpace Biosciences announced this week that it and its subsidiaries have entered into a new $7.5 million revolving credit facility with Comerica Bank. The facility matures on Sept. 30, 2023, and allows for advances based on 80 percent of eligible accounts receivable, plus an applicable non-formula amount consisting of $2 million of additional availability at close, stepping down $250,000 per quarter beginning with the quarter ending June 30, 2022. The interest rate is equal to prime plus 0.5 percent, prime being the greater of the bank's stated prime rate or the sum of the daily adjusting LIBOR rate, plus 2.5 percent per annum, the company said.
CareDx this week filed a notice of its intent to appeal a recent United States District Court for the District of Delaware decision to invalidate three patents held by Stanford University and licensed exclusively to the company. The patents were at the center of an infringement lawsuit that Stanford and CareDx originally filed against Natera and Eurofins Viracor in March 2019. CareDx’s appeals brief is due later this year.
The BICO Group said this week that it has completed its previously announced acquisition of QInstruments, a German developer, manufacturer, and supplier of sample preparation automation tools and technologies, for a preliminary purchase price of €61.25 million ($71.1 million).
The preliminary purchase price is subject to adjustment for net cash/debt and deviation from normalized working capital according to its balance sheet at the closing date, BICO said.
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.