
Thermo Fisher to buy out PPD for $17.4B
Thermo Fisher is spending a major $17.4 billion to buy out contract research organization PPD. If a major medtech/testing company buying a CRO sounds familiar, it’s right out of the

Roche Elecsys Anti-p53 Test for Cancer Diagnosis Earns CE Mark
Roche announced on Wednesday that its Elecsys Anti-p53 immunoassay for the quantitative detection of anti-p53 autoantibodies has received CE marking. The assay is now available in markets that accept the

Chembio Diagnostics Shares Rise 60 Percent on Launch of SARS-CoV-2, Influenza Test
Chembio Diagnostics’ shares closed on Monday up 60 percent on the company’s announcement last week that it is launching a rapid test for the detection and differentiation of SARS-CoV-2 antigens,

LumiraDx to Go Public on Nasdaq Through SPAC
Special purpose acquisition company (SPAC) CA Healthcare Acquisition on Wednesday announced a merger agreement with point-of-care diagnostic testing firm LumiraDx. The merger with CA Healthcare Acquisition would facilitate the listing

BioMerieux Gets CE Mark for Three Dengue Immunoassays
BioMérieux announced Wednesday the CE marking of three immunoassay to detect dengue virus infections. The fully automated assays run on the firm’s Vidas systems. The Vidas Dengue NS1 Ag assay

Hologic Locks Down 4th M&A Target This Year
It doesn’t look like Hologic will be slowing down with M&A this year. The Waltham, MA-based company has announced its fourth deal – the proposed acquisition of Mobidiag Oy, a

Quidel Sofia SARS Antigen Test Obtains FDA Emergency Use Authorization for Serial Screening
Quidel announced Friday that it has obtained Emergency Use Authorization from the US Food and Drug Administration for the intended use of serial SARS-CoV-2 screening using its Sofia SARS Antigen

Gold Standard Diagnostics Nabs FDA Clearance for Lyme Disease Test
Gold Standard Diagnostics (GSD) this week announced that the US Food and Drug Administration has granted clearance for the company’s B. burgdorferi IgG/IgM VlsE-OspC EIA test. The test can now be used

Allarity Therapeutics Seeks FDA Premarket Approval for Prediction Tool as CDx for Dovitinib
Allarity Therapeutics said on Friday that it has submitted a premarket approval application to the US Food and Drug Administration for its DRP platform for use as a companion diagnostic

Diazyme Gets CE-IVD Mark for Coronavirus Neutralizing Antibody Test
Diazyme Laboratories said on Tuesday that it has received the CE-IVD mark for its SARS-CoV-2 neutralizing antibody test. According to Diazyme, the high-throughput chemiluminescent immunoassay is designed to measure the

Altona Diagnostics Receives CE Mark for HIV-1 Viral Load PCR Assay
Altona Diagnostics said on Thursday that it has received CE-IVD marking for and has launched its AltoStar HIV RT-PCR Kit 1.5. The Hamburg, Germany-based firm’s assay leverages reverse transcriptase quantitative

Quest Diagnostics Sells its Share of Q2 Solutions to Iqvia for $760M
Quest Diagnostics has sold its minority share of lab services firm Q2 Solutions to Iqvia for $760 million in an all-cash transaction, the companies said on Thursday. Iqvia and Quest established

DoorDash to Take COVID-19 Test Distribution to a ‘New’ Level
Vault Health and Everlywell are reaching out to DoorDash in an effort to make FDA-authorized COVID-19 test collection kits widely available to consumers. Yup, you read that right medtech is

Roche Receives CE Marking for New High-Throughput Configurations for Cobas Pro
Roche announced on Tuesday that it has received CE marking for eight new configurations for its Cobas Pro Integrated Solutions analyzer. The new configurations have upped the clinical chemistry and

Beckman Coulter SARS-CoV-2 IgG Antibody Test Gets FDA Emergency Use Authorization
Danaher subsidiary Beckman Coulter announced on Tuesday that its Access SARS-CoV-2 IgG II antibody test has received Emergency Use Authorization from the US Food and Drug Administration. The test measures