140 IVD Articles
Posted in IVD by amanda.pedersen on August 9, 2017
p.p1 {margin: 0.0px 0.0px 0.0px 0.0px; font: 11.0px Helvetica} span.s1 {font-kerning: none} span.s2 {font-kerning: none; background-color: #fefefe} Investors just poured $50 million into a blood-based test for infectious diseases, developed by Karius Inc.Amanda Pedersen Liquid biopsy has a... Continue
Posted in IVD by Nancy Crotti on July 28, 2017
German company numares AG is developing a noninvasive test to diagnose bladder cancer, and executives believe the technology can be used to generate other diagnostic tests. Nancy CrottiA German company has developed a system that uses patients’ metabolites to diagnose and monitor certain canc... Continue
Posted in IVD by Daphne.Allen on July 12, 2017
The liquid biopsy, already a leap in diagnostic technology, is advancing further—this time from artificial intelligence (AI).Daphne AllenDr. Jurgi Camblong, CEO and cofounder of SOPHiA GENETICSAt the 2017 Annual Meeting of the American Society of Clinical Oncology, SOPHiA GENETICS unveiled a new s... Continue
Posted in IVD by amanda.pedersen on June 30, 2017
FDA has granted its first-ever authorization for a test that uses flow cytometry to aid in the detection of several leukemias and lymphomas.Staff Report FDA has given Beckman Coulter permission to sell its ClearLLab Reagents, the first agency authorized test for use with flow cytometry to aid i... Continue
Posted in IVD by Daphne.Allen on June 26, 2017
Education and additional rapid diagnostics are needed to help save lives, say advocates.Daphne Allen Deaths from antimicrobial resistance (AMR) could reach 10 million annually by 2050, fears a new industry alliance. Diagnostics manufacturers (along with those developing pharmaceutical and biote... Continue
Posted in IVD by Nancy Crotti on June 7, 2017
Neolys Diagnostics says its kit and lab-based test can detect sensitivity to radiation therapy for cancer patients.Nancy CrottiGuillaume Vogin, MD, PhD, of the Institut de Cancérologie de Lorraine in Nancy, France, presented study results supporting Neolys Diagnostics' technology at ESTRO 2017 in V... Continue
Posted in IVD by Jamie Hartford on June 5, 2017
There is a growing demand for economically viable and flexible diagnostic tools that swiftly deliver accurate results. Dr. Giles SandersTTP’s Desktop Biology service enables diagnostic providers to rapidly convert their biological assays into market-ready point-of-clinic systems cap... Continue
Posted in IVD by amanda.pedersen on May 17, 2017
CDC recommends retesting of certain children, pregnant women, and nursing mothers who have been tested for lead exposure with Magellan Diagnostics’ lead tests.Qmed Staff FDA is investigating a problem related to Magellan Diagnostics’ lead tests after data indicated that the tests may provid... Continue
Posted in IVD by Kristopher Sturgis on April 21, 2017
MeMed Ltd has been awarded a $9.2M Department of Defense contract to support a rapid point-of-care test designed to distinguish between bacterial and viral infections, ultimately helping to mitigate the misuse of antibiotics.Kristopher SturgisMeMed's second-generation point-of-care test is designed ... Continue
Posted in IVD by Nancy Crotti on March 17, 2017
Chinese researchers believe their new, paper-based test could be used in war zones and remote locationsNancy Crotti Chinese researchers have developed a speedy paper blood-type test using a common pH indicator.The researchers used antibodies immobilized on paper test strips to separate red bloo... Continue
Posted in IVD by Daphne.Allen on March 16, 2017
The 60-second rapid HIV test, INSTI, receives innovative technology award.By Daphne AllenHIV-positive patients may not always know they are infected. Routine screening has been a challenge, but one potential solution has just won an innovative technology award and a group purchasing contract with on... Continue
Posted in IVD by Nancy Crotti on March 2, 2017
With colorectal cancer on the rise in young adults, the maker of the Cologuard noninvasive home test for the disease says it might be time to adjust the screening age.Nancy CrottiColorectal cancer is on the rise in young adults, according to a study by the American Cancer Society, which is recommend... Continue
Posted in IVD by amanda.pedersen on February 28, 2017
Data published in the Journal of the American College of Cardiology shows a new blood test detected a significant coronary obstruction 90% of the time, and also tipped doctors off to a patient's risk of a future heart attack.Amanda Pedersen A Massachusetts General Hospital cardiologist said Pre... Continue
Posted in IVD by amanda.pedersen on January 10, 2017
Illumina shares soared Tuesday after the company introduced its newest sequencer, the NovaSeq, that could one day enable researchers to sequence a genome for as little as $100.Amanda PedersenIllumina CEO Francis deSouza said the new NovaSeq, will enable genomic studies that were not possib... Continue
Posted in IVD by Nancy Crotti on December 22, 2016
New models based on test results may help doctors and patients decide whether and when to discontinue aggressive treatment.Nancy CrottiA routine blood test can predict how long cancer patients in palliative care will survive, researchers reported at an oncology conference in Singapore this week.Rese... Continue
Posted in IVD by amanda.pedersen on December 22, 2016
Clinical Genomics’ new blood test does the same thing as a 1970s test, only better.Amanda Pedersen If old dogs can indeed be taught new tricks, perhaps the same is true for blood tests. That appears to be the case with a new blood-based test for colorectal cancer (CRC) recurrence monitoring d... Continue
Posted in IVD by Jamie Hartford on December 15, 2016
State and local officials offered the company millions of dollars in tax breaks, and Siemens Healthineers is responding by adding 400–700 jobs at the Walpole, MA, facility over the next 10 years. Jamie HartfordSiemens will manufacture assays to run on the Atellica Solution analyzer at the Wal... Continue
Posted in IVD by Chris Newmarker on October 27, 2016
CEO Anne Wojcicki describes it as a “hot shiny object” for her industry. But the company wants to focus on core areas for now. Chris Newmarker23andMe—which has made a name for itself selling relatively affordable genetic tests to the masses—has halted its pursuit to create more advanced sequ... Continue
Posted in IVD by Kristopher Sturgis on October 14, 2016
A new technique developed by researchers at MIT can test tumors for drug susceptibility by measuring how cancer drugs affect the growth rate of cancerous tumors in single cells.Kristopher SturgisWhen it comes to cancer treatment, selecting cancer drugs can oftentimes be a process of trial and error.... Continue
Posted in IVD by Nancy Crotti on September 20, 2016
Would FDA regulation of laboratory-developed tests add cost and delays or prevent potential danger to patients? A Senate committee took on the topic this week.Nancy CrottiWho should be regulating laboratory-developed tests (LDTs)? Currently, that’s the purview of CMS via the Clinical Laboratory Im... Continue