NEW YORK – Roche’s Elecsys Amyloid Plasma Panel has received breakthrough device designation from the US Food and Drug Administration, the company said this week. The panel is intended to be used for symptomatic patients who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. The qualitative test measures the Alzheimer’s biomarkers phosphorylated Tau 181 and apolipoprotein E4 in human plasma to determine the need for further confirmatory testing, such as cerebrospinal fluid testing.
MilliporeSigma said this week that it has broken ground at the site of its first lateral flow membrane production facility in the US, located in Sheboygan, Wisconsin. The new facility is supported by a $136.7 million contract from the US Department of Defense on behalf of the US Department of Health and Human Services. Upon completion, it will be able to produce diagnostic-grade lateral flow membranes, a crucial component in rapid diagnostic test kits, including those used for COVID-19 testing. MilliporeSigma is the US and Canada life sciences business of German firm Merck KGaA.
Natera said this week that its Signatera assay has met the coverage requirements for patients with muscle invasive bladder cancer under the Centers for Medicare and Medicaid Services’ MolDx program, effective April 19, 2022. The test is covered under the program’s local coverage determination for minimal residual disease testing for cancer, which went into effect in December 2021. Signatera is also covered by Medicare for colorectal cancer and pan-cancer immunotherapy monitoring.
LumiraDx this week priced its public offering of 43 million common shares at $1.75 per share for gross proceeds of about $75.3 million. The company has granted the underwriters a 30-day option to purchase up to 6.45 million common shares at the public offering price. Goldman Sachs, Evercore ISI, SVB Securities, and Raymond James are the joint book-running managers for the offering, which is expected to close on July 25.
CTK Biotech said this week that the OnSit COVID-19 Ag Self Test has received the World Health Organization’s Emergency Use listing. The single-use lateral flow immunoassay is designed for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens from individuals suspected of having COVID-19. The test is for use with self-collected samples within the first seven days after the onset of symptoms, Poway, California-based CTK Biotech said.
French in vitro diagnostics and biotherapy firm Theradiag said this week that its preliminary revenues for the first half of 2022 rose almost 15 percent year over year to €6.3 million ($6.4 million) from €5.5 million. The company said it had a cash position of €6.0 million as of June 30.
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.