Truvian Sciences announced that it received FDA emergency use authorization (EUA) for its Easy Check COVID-19 IgM/IgG antibody test. San Diego-based Truvian’s test is now being produced at a mass scale at a U.S.-based manufacturing facility and will be made available to healthcare practitioners immediately, according to a news release. The test has undergone validation […]
Genomics/Molecular Diagnostics
Hologic booms on Q3 revenues driven by COVID-19 diagnostics
Hologic (NSDQ:HOLX) shares got a huge boost today on third-quarter results that beat the consensus earnings forecast. Shares of HOLX were up 10.1% at $70.49 before the market opened today, then remained strong during early-morning trading, registering up 9.3% at $69.98. The Marlborough, Mass.-based company posted profits of $136.4 million, or 53¢ per share, on sales […]
Advamed: Diagnostic COVID-19 tests shipments hit 1m
U.S. shipments of COVID-19 molecular diagnostic tests reached 1 million per day for the week ending July 24, based on the latest data from AdvaMed’s national testing registry. The medtech trade group launched the registry July 21 to aid state and federal pandemic responses. “This incredible milestone is just the latest example of how the medical technology industry […]
HHS, DOD invest $7.6m in Hologic COVID-19 test samples
The U.S. Dept. of Health and Human Services (HHS) and Defense Dept. (DoD) announced a $7.6 million contract for COVID-19 testing from Hologic (NSDQ:HOLX). Marlborough, Mass.-based Hologic will receive the contract with a ceiling of $7.6 million so it can expand production of custom sample collection and processing consumables for COVID-19 testing, according to a news […]
LabCorp COVID-19 test may be used on asymptomatic people
The FDA on Friday added two new indications for the use of a Laboratory Corporation of America (NYSE:LH) COVID-19 RT-PCR diagnostic: to test people who have no symptoms of the virus or have no reason to believe they’ve been exposed; and to allow pooled testing of up to five samples from different people. The test, which received an emergency […]
Thermo Fisher rises on COVID-19 response-driven Q2
Thermo Fisher Scientific (NYSE:TMO) shares got a boost today on second-quarter results that came in well above the consensus forecast. The Waltham, Mass.-based company posted profits of $1.2 billion, or $2.90 per share, on sales of $6.9 billion for the three months ended June 27, 2020, for a 3.3% bottom-line gain on sales growth of 9.5%. […]
Quest COVID-19 test wins FDA nod for pooled sampling
The FDA has authorized a Quest Diagnostics (NYSE:DGX) test for COVID-19 to be used with pooled samples — the first such authorization by the agency since Dr. Anthony Fauci, the nation’s leading infectious disease specialist, started publicly discussing pooled-sample testing about three weeks ago. The authorization, announced Saturday, permits the pooled testing of up to four […]
FDA issues EUA for Luminex COVID-19 antibody test
Luminex (NSDQ:LMNX) announced today that it received FDA emergency use authorization (EUA) for its xMAP SARS-CoV-2 multi-antigen IgG assay for COVID-19. Austin, Texas-based Luminex said in a news release that its serology assay can identify the presence of antibodies in those who have been infected with the SARS-CoV-2 virus causing COVID-19. The newly authorized assay can […]
MedTech 100 roundup: Industry hits pandemic peak
After five months since medtech stocks peaked before the COVID-19 pandemic rocked the markets, the industry inched back toward that pre-pandemic high. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 88.9 points at the end of last week (July 17). That total represents just a -3.7% […]
Thermo Fisher boosts offer for Qiagen
Thermo Fisher Scientific (NYSE:TMO) has boosted its per-share offer price for Qiagen (NYSE:QGEN) after some shareholders reportedly balked at the original offer for the sample and assay tech company. Thermo Fisher Scientific is now offering €43 per QGEN share, up from the previous €39 per share offer, at the same time that the companies have agreed to […]
COVID-19 diagnostics sales boost Abbott’s Q2 results
Abbott (NYSE:ABT) beat the consensus forecast on Wall Street today — with sales of molecular diagnostics including COVID-19 tests more than tripling. The Abbott Park, Ill.-based healthcare giant reported profits of $537 million or 57¢ per share, on sales of $7.33 billion for the three months ended June 30, 2020, for a bottom-line plunge of –47% […]