Nirmidas Biotech announced this week that it received FDA emergency use authorization (EUA) for its COVID-19 test in point-of-care settings. Palo Alto, Calif-based Nirmidas Biotech’s MidaSpot rapid COVID-19 antibody combo detection kit uses fingerstick serology testing to detect IgG/IgM antibodies related to the SARS-CoV-2 virus causing COVID-19, according to a news release. MidaSpot, touted by […]
Genomics/Molecular Diagnostics
Hologic says revenue nearly doubled in Q1
Hologic (NSDQ:HOLX) announced today that its revenues nearly doubled year-over-year in the first quarter of fiscal 2021. Marlborough, Mass.-based Hologic expects to report revenues of more than approximately $1.6 billion, an increase of 89.3% from the first quarter of 2020. That tops the company’s November guidance of between $1.35 billion and $1.425 billion for the quarter […]
Hologic to acquire Biotheranostics for $230M
Hologic (NSDQ:HOLX) announced that it agreed to acquire molecular diagnostic test maker Biotheranostics for approximately $230 million. Privately held, commercial-stage Biotheranostics provides molecular diagnostics for breast and metastatic cancers. Both of its tests are PCR-based gene expression tests which have been validated in large studies in areas of oncology with unmet needs and high growth potential, […]
FDA authorized more than 300 COVID-19 tests and collection kits in 2020
The FDA says it authorized more than 300 COVID-19 test and collection kits in 2020. COVID-19 first made waves at the end of 2019 but began to spread throughout the U.S. in the early months of 2020. As the country faced a pandemic, a number of companies developed diagnostics in an effort to slow the […]
FDA warns on false negatives with Curative COVID-19 test
The FDA yesterday alerted healthcare providers and patients that there is a risk of false results with the Curative SARS-CoV-2 test. The Curative SARS-CoV-2 assay is authorized for prescription-only use as a real-time RT-PCR test used to detect the virus causing COVID-19. The test analyzes throat swabs, nasopharyngeal swabs, nasal swabs and/or oral fluid specimens […]
23andMe raises $82.5M
23andMe filed an SEC Form D last month to confirm the sale of approximately $82.5 million in an equity financing round. The DNA testing developer made the first sale in the new notice financing on Dec. 9, 2020. The company is looking to raise $85 million, leaving just $2.5 million remaining to be sold, according […]
DiaSorin gains BARDA funding for COVID-19 testing kit
DiaSorin Molecular announced that it received federal funding from BARDA for its Simplexa COVID-19 direct testing kit. Cypress, Calif.-based DiaSorin’s undisclosed funding total received from the Biomedical Advanced Research and Development Authority (BARDA) is slated to support the validation and submission of the test for FDA 510(k) clearance and the ramp-up of manufacturing capacity for […]
Quidel wins EUA for COVID-19 test with faster runtime
Quidel Corp. (NSDW:QDEL) announced that it received FDA emergency use authorization (EUA) for its Solana SARS-CoV-2 assay. San Diego-based Quidel’s Solana SARS-CoV-2 assay is an isothermal reverse transcriptase-helicase-dependent amplification (RT-HDA) assay designed for the qualitative detection of nucleic acid from the virus causing COVID-19 in nasopharyngeal and nasal swab specimens, according to a news release. Testing […]
SEC charges diagnostics company with fraud over COVID-19 test claims
The SEC announced charges against Decision Diagnostics (OTCMKTS:DECN) and its CEO, alleging false and misleading claims over a COVID-19 blood test. Westlake Village, Calif.-based Decision Diagnostics and its CEO Keith Berman are alleged to have made the claims in numerous press releases, saying that the company had developed a working, breakthrough technology for detecting COVID-19 […]
Abbott secures CE Mark for test that helps measure immune repsonse to COVID-19
Abbott (NYSE:ABT) announced today that it received CE Mark approval for its new SARS-CoV-2 IgG lab-based serology test. The Abbott Park, Ill.-based company’s IgG antibody test for the virus causing COVID-19 offers a quantitative result to help evaluate a person’s immune response to a vaccine, according to a news release. Abbott’s quantitative IgG antibody test detects […]
What are the most effective COVID-19 antibody tests?
The FDA released a list of emergency use authorized COVID-19 antibodies to offer comparisons over the sensitivity of the diagnostics. Among the larger companies on the list with larger sample sizes, antibody tests made by Roche and Siemens were some of the highest-ranking diagnostics, according to the FDA comparison. Tests are in part described by […]