Consumer: Page 6

AACC objects to FDA's at-home virus kit clearance, following go-ahead for Everlywell
By Emily Hayes
The FDA has been approving products related to SARS-CoV-2 rapidly through the EUA pathway. In a letter to FDA Commissioner Stephen Hahn, the AACC said that this haste has resulted in the "introduction of an unproven product into the market." The letter referenced a product that received clearance on May 16, without noting a product or company name.
May 20, 2020
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Diaceutics launches diagnostic network platform for labs
By LabPulse.com staff writers
The platform, called DXRX -- The Diagnostic Network, will be launched in the fourth quarter of this year, the company said. The company plans to invest $28 million in software and data development toward the platform, which will connect more than 2,500 laboratories into a worldwide network.
May 17, 2020
2020 04 28 19 25 1337 Sequencing Dna Rna Pcr 400
Quest unveils COVID-19 antibody test for consumers
By LabPulse.com staff writers
Available via the firm's QuestDirect consumer-initiated testing business without the need to visit a doctor's office, the test can be requested by individuals and purchased online. A licensed physician then reviews the request and, if appropriate, issues an order for testing, according to the company. Blood testing is conducted by appointment at the company's 2,200 patient service centers.
April 27, 2020
2020 04 02 20 02 8495 Quest Diagnostics 400
Lumos gets cash to expand reach of respiratory test
By LabPulse.com staff writers
Lumos is a Planet Innovation spin-off that merged with RPS Diagnostics in May 2019. The company plans to use the funding to support international market expansion of its FebriDx point-of-care (POC) respiratory infection test, as well as a pivotal trial to support approval of the product by the U.S. Food and Drug Administration (FDA).
February 5, 2020
2019 04 26 21 48 5250 Money Hundred Bills 400
UAE launches national radiology-pathology platform
By LabPulse.com staff writers
The UAE's Ministry of Health and Prevention said the new platform would collect data to serve as a reliable medical reference and diagnostic support system for physicians throughout the country. It would also provide a platform for physicians to share opinions with each other about diagnoses.
January 30, 2020
2020 01 30 21 30 5192 Dubai Waterfront 400
UAE launches national radiology-pathology platform
By LabPulse.com staff writers
The UAE's Ministry of Health and Prevention said the new platform would collect data to serve as a reliable medical reference and diagnostic support system for physicians throughout the country. It would also provide a platform for physicians to share opinions with each other about diagnoses.
January 29, 2020
2020 01 30 21 30 5192 Dubai Waterfront 400
What's next for PacBio and Illumina?
By Bruce Carlson
San Diego-based Illumina is the maker of the most successful sequencing products, including the MiSeq and NextSeq brands, with the largest share of the market, according to Kalorama Information's research. Pacific Biosciences develops long-read sequencers under the Sequel brand.
January 15, 2020
2020 01 16 01 29 7883 Businessman 2020 Start 400
Personalis launches Next Dx cancer profiling test
By LabPulse.com staff writers
The company differentiates the whole exome and transcriptome sequencing product through the comprehensive nature of the profiling, as the platform screens for some 20,000 genes in the tumor exome and transcriptome, in contrast with only a few hundred genes available with some currently marketed products. Personalis noted that the product sheds light on cancer genes and biomarkers that are important for directing treatment with cancer immunotherapies, such as tumor mutational burden (TMB) and microsatellite instability (MSI) status.
January 7, 2020
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Top 10 product news stories for 2019
By Bruce Carlson
In fact, there were hundreds of developments in IVD testing in 2019 and selecting just 10 is a big challenge. But based on its decades of assessing and forecasting the market Kalorama Information selected the news items below as highly significant from the point of view of product advances.
December 23, 2019
2019 11 08 17 54 6978 News Ball 400
Veracyte licenses NanoString diagnostic platform in $50M deal
By LabPulse.com staff writers
Per the deal, NanoString is due another $10 million as Veracyte's tests are launched on the platform commercially. NanoString's platform enables the simultaneous analysis of RNA, DNA, or protein targets for up to 800 genes.
December 3, 2019
2019 07 08 18 08 5459 Men Working Business 400
State of the IVD market: New cancer and infectious disease tests emerge
By Bruce Carlson
Kalorama routinely assesses market opportunities and trends using a combination of vendor interviews and secondary research, and it published its "Worldwide Market for In Vitro Diagnostic Tests" report in August. In October, Kalorama performed an updated analysis, and while general market trends have not changed from August, the firm identified new trends and made some regional assessments.
November 26, 2019
2019 11 26 23 09 8685 Graph Financial Results Global 400
Invitae deploys Apple Watch for cardiovascular genetics study
By LabPulse.com staff writers
The first application of the platform -- dubbed Invitae Discover -- will be cardiovascular disease, the company said in an announcement ahead of the of the American Heart Association (AHA) annual meeting taking place November 16-18 in Philadelphia.
November 14, 2019
2019 11 15 20 31 2385 Computer Heart 400
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