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Published on December 7, 2020
When Congress reconvenes in January, the lengthy docket of action items is expected to include proposed solutions to the years-long conundrum over how to regulate laboratory developed tests (LDTs). The FDA touched off the issue in 2014 when it proposed regulating “high-risk” LDTs along the lines of Class III medical…
Published on November 20, 2020
Michael Heltzen, CEO and co-founder of Cardea Bio, a San Diego startup integrating tiny bits of biology into modern electronics, believes that the way researchers have been observing biological signals is about to change. Our ability to “see” detail in space and time is limited by resolution. Take, for example,…
Published on September 28, 2020
Microbiomics is taking a sharp turn. Until now, the field was limited to fecal transplants from healthy patients to those with gut conditions. The transplant is an awkward procedure that also creates regulatory and other challenges. But as the field has progressed, companies today are pushing forward to adapt technologies…
Published on August 14, 2020
Thermo Fisher Scientific today terminated its agreement to acquire QIAGEN after the would-be buyer failed to persuade enough QIAGEN shareholders to approve the potentially $12.5 billion deal. Shareholders with only 47% of outstanding QIAGEN shares agreed to support the acquisition deal, which required approval by owners of 66.67% of those…
Published on August 3, 2020
Biomarkers hold out the promise of significant time and money savings for drug discovery and development, but finding the right ones is notoriously tough. Many putative biomarkers fail validation after years of study, leaving developers poorer but not much wiser—a fact that highlights the complexity of biomarker development. But a…
Published on July 31, 2020
Guardant Health will partner with Radius Health to pursue approvals for Guardant’s Guardant360® CDx liquid biopsy as a companion diagnostic for Radius’ Phase III breast cancer therapeutic elacestrant (RAD1901), through a collaboration whose value was not disclosed. Elacestrant is a selective estrogen receptor degrader (SERD) being studied in the treatment of advanced…
Published on July 16, 2020
In response to restricted access to critical diagnostics for cancer patients resulting from the COVID-19 pandemic, a Canadian consortium led by Canexia Health (formerly named Contextual Genomics) has launched Project ACTT (Access to Cancer Testing & Treatment). The CAD $2,590,000 initiative will leverage liquid biopsies for cancer testing in an…
Published on June 26, 2020
Clinical laboratories are showing signs of rallying after the recent slump in activity due to COVID-19, according to a new study from Arlington, Va.-based Kalorama Information, an in vitro diagnostics market research firm. The study, released June 25, found labs are running more tests and a greater variety of them…
Published on June 23, 2020
Invitae has agreed to acquire ArcherDx for up-to-approximately $1.4 billion, in a deal that would bring germline and somatic testing, liquid biopsy technologies and services, as well as tumor tissue genomic profiling onto a single platform The deal—announced just two weeks after ArcherDx filed for a $100 million initial public…
Published on June 18, 2020
Illumina announced yesterday it has acquired BlueBee, which provides a rapidly configurable data analysis platform for researchers and clinicians alike. Price of the acquisition was not disclosed. According to Illumina, BlueBee’s genomics analysis solutions which are designed to extract insights from genomic data into its cloud portfolio, will allow the…
Published on June 15, 2020
As the field of precision medicine matures, it requires evermore technological improvements across a broader base of disciplines. Our list of half-a-dozen companies that are providing innovative solutions is no exception. From new applications of NGS and non-invasive testing, to leveraging technology to handle disparate datasets and solve genetic counseling…
Published on June 15, 2020
Molecular diagnostics for everything from cancer testing to what medications doctors should prescribe—or not prescribe—for heart disease, mental health and a host of other conditions have been steadily increasing their share of the diagnostics pie over the past five years. That was until COVID-19 and the subsequent, ongoing global pandemic…
Published on May 21, 2020
Has Abbott announced a government contract to supply millions of its laboratory-based IgG antibody tests to National Health Service (NHS) laboratories across the U.K. over the coming months. Abbott has capacity to provide significant numbers of tests to the UK and has already shipped 800,000 antibody tests this week to…
Published on May 7, 2020
CRISPR engineering biology company Sherlock Biosciences today announced today that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Sherlock CRISPR SARS-CoV-2 test kit for the detection of the virus that causes COVID-19. “While it has only been a little over a year…
Published on April 6, 2020
Molecular diagnostics and assay development company Luminex announced today that its ARIES SARS-CoV-2 Assay for rapid detection of the virus that causes COVID-19 has received and Emergency Use Authorization from the FDA. According to the company, the test will run on its FDA-approved ARIES system an automated system that can…