April 20, 2017 –
NEW YORK -- (GenomeWeb, Justin Petrone) -- Applied Biocode intends to have a panel for identifying 18 different gastrointestinal pathogens on the clinical market by the end of the year.
CEO Winston Ho said that the Santa Fe Springs, California-based molecular diagnostics company will soon commence clinical trials for the assay, called the Gastrointestinal Pathogen Panel, which runs on its barcoded magnetic bead-based multiplex BioCode MDx 3000 system, at five sites in the US.
If all goes well, the company will submit the clinical trial data to the US Food and Drug Administration for 510(k) clearance by the end of June. Should the agency clear the test and system, it will become Applied Biocode's first in vitro diagnostic product on the clinical market. It will also allow the firm to directly challenge Luminex, which offers its own FDA-cleared xTAG Gastrointestinal Pathogen Panel for 14 microorganisms on several instruments.
Luminex has been offering xTAG GPP to high-volume laboratories for clinical use since 2013 and the firm has considered the assay to be a growth driver. However, according to Ho, as well as to Bob Wessel, a marketing and strategic planning consultant who works for Applied Biocode, the availability of their GPP and BioCode MDx 3000 system could temper Luminex's dominant market position.
"This is a very rapidly growing market and customers with whom we have talked about the system really want it badly," Wessel said of Applied Biocode's offering. "We are planning to displace Luminex," he noted. "Luminex is a non-automated system, some of their customers have not been happy with that, and they are looking for another solution."
Representatives for Luminex declined to comment on Applied Biocode's statements.
Ho, who is also Applied Biocode's CTO, founded the firm in 2008 to commercialize its barcoded magnetic bead technology, where DNA targets are coupled to barcoded beads, providing a high-contrast transmitted signal, no fluorescence background, and nearly 100 percent decoding accuracy, according to the company. Applied Biocode's BMB technology provides up to 4,096 unique digital barcodes for multiplex analysis, he noted, and the technology is protected by several US patents.
The new BioCode MDx 3000 system is based on a 96-well microplate format, which should spur its adoption in clinical labs, Ho said. The system automates the PCR amplification, hybridization, and detection steps of the assay, and it can process up to 94 patient samples in less than five hours.
"It's a high-throughput, automated multiplex system, and we are targeting the high-volume labs with it," said Ho of the company's offering.
Applied Biocode has long eyed the infectious disease testing market as a primary opportunity for the technology, and its GPP has been in development for years. The assay simultaneously detects and differentiates between 18 diarrhea-causing pathogens, including bacteria like Campylobacter and E. coli O157, viruses such as Rotavirus A, and parasites like Giardia lamblia.
Ho said that the company also has a respiratory virus panel in its pipeline, and would seek FDA clearance for that test, too, once it sees its BioCode MDx 3000 system cleared for clinical use. Wessel commented that Applied Biocode also offers a version of the system that will enable users to run their own custom assays, therefore easing its path to adoption for laboratory-developed tests. For this, the company will also have Luminex as a main competitor, which already offers an FDA-cleared xTAG Respiratory Virus Panel and enables customers to develop their own tests.
Applied Biocode recently concluded beta site trials for its GPP assay at the University of California, Los Angeles, and at Poplar Healthcare, a Memphis, Tennessee-based laboratory services company. Ho said that one of the beta users will take part in the clinical trial as well, although he declined to say which one or name any of the other sites.
Anami Patel, vice president of genomics operations and development at Poplar Healthcare, oversaw the beta trial at that site and said that it is possible that Applied Biocode could win over customers who are looking for greater automation for gastrointestinal pathogen testing.
"When Luminex introduced multiplex testing for that indication, it brought a very good molecular tool into the market as a first mover," Patel said. "Our physicians were very excited about ordering that test when it became available and I had never seen such excitement for such a test."
Though the xTAG GPP takes about six or seven hours to complete, he said, it was "still better than culture," the conventional method that many labs still employ, and "brought a lot of efficiency" to his laboratory.
While he noted that Applied Biocode's GPP has a few more targets than Luminex's offering, he said that its greater degree of automation is also a positive for Applied Biocode's offering as there is "less room for error." To date, Poplar has run about 400 specimens on the system, and Patel said that Applied Biocode's automation, as well as its software, which he described as easy to use, are both important for lab efficiency.
Pricing for the system remains unknown, although Ho said it will be competitive. Patel said that he is "very curious" about how much Applied Biocode's offering might cost, adding that an automated system like the BioCode MDx 3000 would certainly fit into Poplar's workflow, where about 90 specimens are analyzed every day. Because of that volume load, other, less automated offerings, such as BioMérieux's BioFire Diagnostics FilmArray Gastrointestinal Panel, which gained FDA clearance in 2016 and allows users to test for the presence of 22 different pathogens in one sample at a time, are not directly competitive for Poplar's lab. "BioFire won't fit into our workflow," he said.
It is unclear if Luminex is planning to update the GPP to counter any challenge from Applied Biocode. In recent months, the company has progressed with bringing in vitro diagnostics to market, albeit on its newer, real-time PCR-based ARIES system. In January, for instance, it gained FDA clearance for its Aries Group B Streptococcus (GBS) assay for antepartum detection of GBS colonization in pregnant women. Last year, the company also acquired Nanosphere for $58 million, and integrating the molecular diagnostics company has also been a focus for Luminex.
Like Patel, Sanjib Bhattacharyya, laboratory director of the City of Milwaukee Health Department, who has used Luminex's xTAG GPP, described the assay as "the first of its kind" on the market but acknowledged that there would be many more and that molecular testing had become "very popular" in labs that conduct infectious disease testing versus conventional culture.
However, he said that some public health reference labs are concerned that these new platforms miss the opportunity for culture-based antimicrobial susceptibility testing, which he described as "critical" for assessing microbial drug resistance as well as for future drug development. He also said that the availability of such high-throughput multiplex systems, like the ones offered by Applied Biocode, would only increase the need for skilled clinical interpretation.
"Since these panels will bring in lots of information, understanding the cause of diseases and symptoms, [and] infection versus colonization for some of those pathogens will be important for optimal therapy and antibiotic use, for those [in] need," said Bhattacharyya.
He added that while resistance detection is currently limited on such panels, it may become available as the field moves from phenotypic to genotypic susceptibility testing. He suggested that test developers increase their cooperation with clinical and public health reference laboratories, to spur such advances.
"Infection control practitioners will be valuable for defining algorithms and judicious use of these enteric panels," Bhattacharyya said.
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.