March 29, 2017 07:07 AM Eastern Daylight Time –
SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Today, Applied BioCode announced that they have completed their beta site trials for the BioCode MDx 3000 and their 18-Plex Gastrointestinal Pathogen Panel. The beta site trials were held at both the University of California, Los Angeles, and at the Poplar Healthcare Laboratory in Memphis, TN, and were completed during January and February this year. Applied BioCode have begun shipping systems to their clinical evaluation sites in March. "Completing the beta site trials is an exciting milestone for Applied BioCode," stated Winston Ho, President of Applied BioCode. "We have tested our new investigational molecular diagnostics system in clinical laboratories and have gotten excellent feedback on the diagnostic utility of the BioCode MDx 3000 system."
At Poplar Healthcare, Anami Patel, Ph.D., Vice President of Genomics Operations and Development, was in charge of the Beta Site Trial. He stated: "The BioCode MDx 3000 performed very well in our laboratory. Once we were trained on the BioCode MDx 3000 system we found it very easy to operate. We expect the BioCode MDx 3000 system to provide a workflow advantage for our laboratory and will be an ideal solution for high volume, highly multiplex molecular diagnostic testing."
At the UCLA Health System, Romney Humphries, Ph.D., Section Chief of Clinical Microbiology and Assistant Professor, stated, "We completed the beta testing on the BioCode MDx 3000 system and it went well." Winston Ho also said that he expects that the clinical evaluations from five sites will be concluded by June with submission to the FDA in the subsequent months. FDA 510k clearance is possible in the 4th quarter of 2017.
February 09, 2017 06:07 AM Eastern Standard Time –
SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode is pleased to announce that they have been accepted for listing on the Taiwan Emerging Market Stock Exchange (ticker symbol 6598).
As a registered Cayman Island corporation with facilities in the United States and Taiwan, Applied BioCode designs, develops, and commercializes innovative high value automated products for the Molecular Diagnostics medical industry. Their products and services will revolutionize the industry providing hospitals and reference laboratories with the ability to perform rapid, high volume, low cost molecular diagnostic testing for multiple pathogens. The Applied BioCode automated system* with multiplexing testing capability will allow earlier intervention of therapy by physicians, provide improved outcomes for patients, and globally lower overall healthcare costs.
Dr. Winston Ho, President of Applied BioCode, stated that he is very pleased that they have qualified for acceptance onto the Taipei Stock Exchange.
June 16, 2016 4:07 AM Pacific Daylight Time –
SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode announced that it has signed a Partnership and Supply Agreement with Diatherix Laboratories, LLC, a Eurofins company. Diatherix Laboratories will utilize Applied BioCode's Barcoded Magnetic Beads and BioCode detection systems in conjunction with their proprietary TEM-PCR™ technology to develop highly sensitive multiplex molecular diagnostic infectious disease panels for their laboratory customers.
"We are very pleased to partner with Diatherix Laboratories in this important area of the market," said Winston Ho, President of Applied BioCode. "Our Barcoded Magnetic Beads combined with the Diatherix TEM-PCR™ technology will provide an elegant solution for multiplexing of molecular diagnostic infectious disease tests. We embrace their ability to quickly identify co-infections and link diagnostics testing to the right therapeutic to significantly improve patient outcomes and reduce overall healthcare costs."
"We are pleased to partner with Applied BioCode for their Barcoded Magnetic Bead technology," said Dennis Grimaud, CEO of Diatherix Laboratories. "Their Barcoded Magnetic Bead technology will allow us to reduce the development timeframe to bring new multiplex test panels to market and enhance the sensitivity of our molecular diagnostic panels. We look forward to a long and successful partnership with Applied BioCode."
February 09, 2016 11:48 AM Pacific Standard Time –
SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--The first patent for a digital barcode was issued to inventors Joseph Woodland and Bernard Silver in 1949. Decades later, in 1974, the first scanner for reading digital barcodes was installed at a Marsh's supermarket in Troy, Ohio. Digital Barcodes soon became the industry standard and the most widely used method for identifying information on millions of products. Applied BioCode today announced that the United Stated Patent and Trademark Office has granted US Patent #9,255,922 (February 9, 2016), describing the material and method of a digital barcode, which is 1,000 times smaller than the conventional barcodes, for simultaneously identifying thousands of bacteria, viruses, pathogens, or biomarkers. This patented Barcoded Magnetic Bead allows the 4,096 available barcodes to be easily scanned and accurately identified with no ambiguity.
Applied BioCode develops biopolymer-base micrometer scale barcoded magnetic beads, which not only have great physical properties (density, rigidity, temperature, pressure, shelf-life stability) and chemical properties (pH stability, surface chemistry, bio-functionalities), but also have excellent biological compatibility (nucleic acids, proteins, buffers, and long term stability) for biological applications. "The new patent expands our four earlier granted patents including the optical scanner that is responsible for decoding the digital barcode and identifying each analyte target in the sample," said Winston Ho, Ph.D., President of Applied BioCode. "These patents solidify our intellectual property portfolio by further protecting our encoded polymer bead technology and providing our products with long term market value."
Applied BioCode is currently developing an 18-plex Gastrointestinal Pathogen Panel for the most common pathogens including viruses, bacteria and parasites that cause infectious diarrhea. The 18-Plex GI Pathogen Panel will be run on the BioCode MDx 3000 Molecular Diagnostic System. This system combines the amplification, hybridization, and detection steps with the capability to run up to 188 samples in an 8-hour shift, and up to three different multiplexed panels simultaneously. The multiplexed panels are run in a low cost, high throughput 96 well microplate format. The automation of these steps into a single system will decrease reagent costs, reduce hands on time, and minimize the potential risk of sample contamination. Submission to FDA is expected later this year.
October 20, 2015 11:34 AM Pacific Daylight Time –
SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode announced today that its abstract for a poster on "18-Plex Gastrointestinal Pathogen Detection with a User Friendly, High Throughput System" has been accepted for presentation at the Association for Molecular Pathology meeting, November 5-7 in Austin, TX.
The poster will cover the development progress of Applied BioCode's new high throughput, multiplex automated MDx system. The new BioCode platform utilizes Applied BioCode's proprietary Barcoded Magnetic Beads (BMB) and fully automates the process of amplification, target capture and detection for molecular diagnostic assays.
The poster will also provide the latest analytical and performance data for the 18-plex Gastrointestinal Pathogen Panel that is currently in development. The BioCode 18-plex GI Pathogen Panel includes targets for the bacteria (Campylobacter, Clostridium difficile toxin A&B, Salmonella, Shigella, E. coli O157, Enterotoxigenic E. coli, Enteropathogenic E. coli, Shiga toxin producing E. coli, Enteroaggregative E. coli, Vibrio spp., Vibro parahaemolyticus, Vibro Vulnificus, Vibro Cholerae, Yersinia Enterocolitica), viruses (norovirus group I/II, adenovirus 40/41, rotavirus A), and parasites (Giardia, Cryptosporidium, Entamoeba histolytica).
Preliminary data generated for the Gastrointestinal Pathogen Panel with the automated system will be presented by Applied BioCode's scientific personnel.
May 5, 2015 - Applied BioCode Licenses Patents to Molecular Devices.
August 22, 2013 - Applied BioCode passed a QSIT (quality system inspection technique) audit conducted by the U.S. Food and Drug Administration (FDA) on August 21, 2013 with No Action Indicated (NAI) for a Class II medical device manufacturer of Barcoded Magnetic Beads (BMB) and BMB Analyzers.
January 10, 2012 - Hologic to Use Applied BioCode's Barcoded Magnetic Beads for Ag-Bio Tests.
September 19, 2011 - Applied BioCode's Quality System is Consistent with the U.S. FDA's QSR Approach.
April 19, 2011 - EraGen to Use Applied BioCode's Technology in Molecular Tests.