Paullee
3 years ago
ProPhase Labs Diversifies with Formation of Genomics and Global Healthcare Subsidiaries
ProPhase Labs, Inc.
Thu, June 10, 2021, 8:30 AM
PRPH
-0.19%
ProPhase Precision Medicine, Inc. and ProPhase Global Healthcare, Inc. to Expand Opportunities in Genomics and International Testing Services
ProPhase Diagnostics, Inc. Developing New Testing Capabilities through Research and Acquisition
CEO Ted Karkus to Discuss New Initiatives at LD Micro Invitational XI Virtual Conference Today at 1:00 p.m. ET
GARDEN CITY, NY, June 10, 2021 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH), a diversified medical science and technology company, today announced the formation of two wholly-owned subsidiaries, ProPhase Precision Medicine, Inc., which will focus on genomics testing technologies, and ProPhase Global Healthcare, Inc., which was recently formed to seek to expand the Company’s SARS-CoV-2 (COVID-19) testing into other countries and to pursue additional healthcare-related initiatives.
ProPhase Precision Medicine will seek to acquire existing businesses and technology, or otherwise gain access to technologies utilized to conduct whole-genome sequencing (WGS). WGS is a comprehensive method for analyzing entire genomes, including the genes and chromosomes in DNA. The data obtained from genomic testing can help to identify inherited disorders, predict disease risk, identify expected drug response, and characterize genetic mutations, including those that drive cancer progression. The costs associated with whole genome sequencing have dropped dramatically in recent years, leading to new services that can provide more detailed testing, better diagnoses, and an ability to predict the viability of therapeutic treatments.
“Whole genome sequencing is rapidly becoming a key component of the future of healthcare, with the ability to test every base in the genome,” said Ted Karkus, CEO of ProPhase Labs. “ProPhase Precision Medicine was created to explore opportunities to capture market share in the estimated multi-billion-dollar market of genomic diagnostics, offering patients the ability to understand and make informed choices about the unique genomic variants in each of us. A genomics business within the Company may be synergistic with our existing ProPhase Diagnostics operations if we are able to conduct these activities in conjunction with our current CLIA labs and leverage the extensive infrastructure already built for our other lab testing services. We intend to explore available solutions that may fit our strategy.”
“ProPhase Global Healthcare was launched with the goal of developing COVID-19 testing facilities internationally and conducting additional healthcare-related initiatives,” continued Mr. Karkus.
Karkus added, “With the onset of the global pandemic, testing demand has increased dramatically around the world, and we are well positioned to leverage our knowledge and efficiencies to capture additional share in the global testing market. As we continue to seek new laboratory acquisition targets, we are now open to opportunities that are outside the United States. This business unit is formed to pursue international opportunities in a subsidiary that will be organized in a manner best suited to international transactions.”
“Consistent with our diversification strategy, ProPhase Diagnostics is now developing antigen and antibody tests in partnerships with scientists to broaden our COVID-19 testing beyond RT-PCR testing. Additionally, we are considering the acquisition of other laboratories in the U.S. that may provide pathology, toxicology, blood, urine and oncology testing in order to expand beyond COVID-19 testing. Taken together, we are highly focused on leveraging our success in the testing business to expand into other high value testing capabilities through accretive acquisitions, licensing opportunities and R&D both here and abroad.”
Mr. Karkus added that, although the Company aspires to identify and consummate possible acquisition and expansion targets and opportunities, there can be no assurance that the Company will be able to do so.
Conference Reminder
CEO Ted Karkus will present at the LD Micro Invitational XI virtual conference taking place June 8-10, 2021. He is scheduled to host a virtual presentation during the event as follows:
2021 LD Micro Invitational XI
Date: Thursday, June 10, 2021
Time: 1:00 p.m. EDT – Track 2
Webcast: https://ldmicrojune2021.mysequire.com
A live audio webcast and archive of the event presentation will be available using the webcast link above. For more information on the LD Micro Invitational XI, or to register for the event, please visit https://ldmicrojune2021.mysequire.com.
Paullee
3 years ago
ProPhase Labs Begins Advanced, Saliva-based Viral PCR Multiplex-Testing for COVID-19, Influenza A & B, and Other Viruses After FDA Confirmation of Two Emergency Use Authorizations
More content below
ProPhase Labs, Inc.
Tue, February 9, 2021, 8:30 AM
More content below
PRPH
-2.40%
Company Integrates Spectrum Solutions™ SDNA-1000 Saliva Collection System for Advanced, Simultaneous Multi-Viral Detection of Infections and Viral Mutations
GARDEN CITY, NY, Feb. 09, 2021 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH), a diversified medical science and technology company, has begun new saliva-based, viral RT-PCR multiplex-testing as a laboratory developed test (LDT) classification. Emergency use authorization (EUA) applications have been filed and confirmed by the U.S. Food and Drug administration (FDA) for its two new testing methodologies. Testing integrates the Spectrum Solutions saliva self-collection system with a new, advanced multiplex qPCR platform for the simultaneous RNA detection of not only SARS-CoV-2 (COVID-19) but also COVID-19 viral mutations, as well as Influenza A, B, and more.
This new SDNA Viral™ saliva-based testing combo features pain-free self-collection, 100% in-device viral neutralization, removes the need for cold-chain storage of samples, and provides critical sample consistency for optimal accuracy. It additionally offers patients the most intuitive and safest sample collection process while delivering the most robust testing biomaterial for the detection of multiple viral infections or mutations in a single test.
Spectrum Solutions, innovative medical device manufacturer and industry leader in bio-sample collection devices, helped secure the FDA’s very first saliva-based testing EUA and continues to lead the charge in saliva-based molecular diagnostic solutions and research. This new, efficient, and cost-effective multi-viral testing product has been engineered to increase testing accuracy and overcome the challenges of limited samples and costly analysis.
This testing provides patients an immediate diagnostic advantage using a single saliva test to quickly detect and identify COVID-19, any of its 17+ current viral mutations, including those first reported in the United Kingdom and now found throughout the United States as well as Influenza A and B. With test processing already underway at both ProPhase New York and New Jersey CLIA certified lab locations, this new, innovative technology ensures optimal assay reliability, offers numerous diagnostic advantages over other testing applications, and delivers the capacity to process more than 60,000 tests per day.
“We are privileged to be working with Spectrum Solutions, one of the leading life-science companies in the world on innovative testing solutions for detecting dangerous viruses including COVID-19,” said Ted Karkus, CEO of ProPhase Labs. Mr. Karkus added: “This collection device and multiplex testing methodology deliver significant value to testing that other platforms have missed. Not only does our methodology identify the original COVID-19 virus, our assay also has the multiplex capability of identifying Covid-19 viral mutations. With the FDA deciding to limit its review of EUA submissions for COVID-19 laboratory developed tests, receiving confirmation of a formal review from the FDA device division is a great win for all of us. Our new state-of-the-art molecular diagnostic testing equipment from Thermo Fisher not only streamlines testing results but prepares us for additional testing capabilities moving forward.”
“Testing is the purposeful pursuit of understanding a disease and a window into each individual’s personalized response,” said Bill Phillips, Chief Operating Officer at Spectrum Solutions. Mr. Phillips added: "Without testing, patients and medical professionals would not be able to make informed decisions on the proper treatment path. We could not be more excited to partner with industry front-runner ProPhase Labs on the new Spectrum SDNA Viral testing solution. The industry needs more innovative testing collaborations like this, delivering real actionable insights, to help move us all forward."
This collaboration coupled with other technologies and innovations will continue to provide a wide range of laboratory testing services for the diagnosis, screening, and evaluation of additional diseases. For more information on the RT-PCR multiplex testing, competitive pricing and some of the industry’s fastest testing turnaround times, please contact us at 866-7LAB TEST (866-752-2837) or info@prophasedx.com
ABOUT SPECTRUM SOLUTIONS™, SPECTRUM DNA™
Headquartered in Salt Lake City, Utah, Spectrum Solutions and its medical device division, SpectrumDNA, focus their industry expertise on engineering innovative end-to-end solutions for clinical diagnostic projects and commercial product plans. A single-source solution provider for medical device development, manufacturing, custom packaging, kitting, and direct-to-consumer fulfillment. Their bio-sample collection devices, patented technologies, and dedicated client services deliver measurable process optimization, unprecedented efficiency, and unmatched global scalability. For more information, please visit spectrumsolution.com/SDNA.
About ProPhase Labs
ProPhase Labs (NASDAQ: PRPH) is a diversified medical science and technology company with deep experience with OTC consumer healthcare products and dietary supplements. The Company is engaged in the research, development, manufacture, distribution, marketing and sale of OTC consumer healthcare products and dietary supplements in the United States. This includes the development and marketing of dietary supplements under the TK Supplements® brand. The Company’s subsidiary, ProPhase Diagnostics, Inc. (“ProPhase Diagnostics”), offers COVID-19 and other Respiratory Pathogen Panel (RPP) Molecular tests. The Company also continues to actively pursue strategic investments and acquisition opportunities for other companies, technologies, and products. For more information visit us at www.ProPhaseLabs.com.
Paullee
3 years ago
this should be the start
ProPhase Labs Announces Opening of Large CLIA Lab Covid Testing Facility in Garden City, New York
ProPhase Labs, Inc.
Updated Fri, January 29, 2021, 8:52 AM
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- Total Company Processing Capacity On Track to Reach 60,000 Tests Per Day –
GARDEN CITY, NY, Jan. 29, 2021 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH), a diversified medical science and technology company, announced today the opening of its 25,000 square foot facility in Garden City, New York. The new lab features state-of-the-art technology and offers a wide range of laboratory testing services for diagnosis, screening and evaluation of diseases, including COVID-19 and Respiratory Pathogen Panel Molecular tests.
The lab features the latest Thermo Fisher Scientific lab equipment and employs approximately 75 technical staff. The Company will add additional technical staff to meet client needs as the lab continues to ramp-up. The lab is already processing COVID-19 tests, and the Company plans to expand lab capacity to be able to process up to 50,000 COVID-19 tests per day by the end of the current fiscal quarter. The technology embedded in the new lab will enable the Company to offer highly competitive pricing to customers and to deliver test results, in most cases, within 24 hours. The lab also will be operating and processing tests seven days a week.
“We are exceptionally proud of our team’s rapid buildout of the new lab and successful onboarding of a world-class technical staff for the new facility. Our strategic rollout of CLIA Labs is proceeding exactly as planned,” said Ted Karkus, CEO of ProPhase Labs. “Our two labs, Garden City, New York and Old Bridge, New Jersey, working in tandem, are expected to enable us to process 60,000 tests per day. In addition to COVID-19 testing, we are looking to diversify into other areas of high margin diagnostic molecular testing,” explained Karkus.
ProPhase Diagnostics Update
ProPhase Diagnostics, Inc., a wholly-owned subsidiary of the Company, which was formed to aggregate medical testing business opportunities for the Company, continues to expand its lab capabilities and testing capacity by expanding its physical presence to include the new Garden City, New York location and adding several key new hires to its team.
Steve Kamalic, Chief Operating Officer - ProPhase Diagnostics
Steve Kamalic is a veteran operations executive with decades of experience building and growing lab processing units. At ProPhase Diagnostics, Steve will be responsible for ensuring the company meets its stated goal of 60,000 tests per day between its Garden City, New York lab and Old Bridge, New Jersey lab. Prior to joining ProPhase Diagnostics, Steve served as Chief Operating Officer and Sales Director at a substantial regional lab. He oversaw a laboratory business that significantly grew its annual revenues. He has worked at several startups and has a vision for growth and expansion. Steve holds an AAS in medical technology and a BS in Health Administration.
Sergio Miralles, Chief Information Officer - ProPhase Diagnostics
Sergio Miralles is an experienced IT Leader, with over 12 years of experience in enterprise level Cybersecurity, Infrastructure, and Architecture. At ProPhase Diagnostics, Sergio will be responsible for ensuring a complete end-to-end technology solution that links its lab customers’ patient data via interface to efficiently process and report results. Previously, Miralles founded and led a successful IT consulting firm overseeing 18 IT consultants. For the last 5 years, his primary focus has been on the medical, lab, and diagnostics business. Sergio holds several certifications from Cisco, ISC2, and CompTIA.
Carlos D. Brewster, Head of Molecular Lab Testing - ProPhase Diagnostics
Carlos Brewster has over 18 years of experience in the Molecular Biology field, which started with an internship with the Federal Government in Washington DC. Carlos’ current responsibilities encompass assay design, validation, implementation and training. Prior to joining ProPhase Diagnostics, he served as a Research and Development Specialist. Since the onset of the pandemic he has received several FDA Emergency Use Authorizations for the COVID-19 Assay, which is now being utilized within the industry by numerous laboratories and has generated millions of dollars in revenue. Carlos holds a Bachelor of Science in Biology. He also holds a New York State License as a Clinical Laboratory Technologist.
Karkus added: “We are privileged to welcome these three experts in their respective fields to the ProPhase team. Steve has decades of experience building out lab processing, and his knowledge will be of great value as we continue our expansion efforts. Sergio will help us to bridge the gap between lab processing and the more difficult challenge of linking to customers via an interface to efficiently upload patient data and report results in a timely and efficient manner. Carlos was instrumental in the purchase, acquisition and installation of the latest Thermo Fisher equipment for our New Jersey lab and our new New York facility. Carlos’ focus will now be on helping us to expand our overall testing capacity and achieve our goal of hitting 60,000 tests per day. Together, the leadership team at ProPhase Diagnostics is coming together, and I have never been more confident in their ability to position us as a leading testing provider.”
About ProPhase Labs
ProPhase Labs (NASDAQ: PRPH) is a diversified medical science and technology company with deep experience with OTC consumer healthcare products and dietary supplements. The Company is engaged in the research, development, manufacture, distribution, marketing and sale of OTC consumer healthcare products and dietary supplements in the United States. This includes the development and marketing of dietary supplements under the TK Supplements® brand. The Company’s subsidiary, ProPhase Diagnostics, Inc. (“ProPhase Diagnostics”), offers COVID-19 and other Respiratory Pathogen Panel (RPP) Molecular tests. The Company also continues to actively pursue strategic investments and acquisition opportunities for other companies, technologies and products. For more information visit us at www.ProPhaseLabs.com.
Paullee
3 years ago
ProPhase targets 'enormous goal,' expects $100M in new revenue from Covid-19 pivot
By John George – Senior Reporter, Philadelphia Business Journal
Jan 13, 2021, 12:34pm EST
A Bucks County over-the-counter health care products and supplements company that late last year pivoted to Covid-19 testing is now performing more than 1,500 such tests a day — and expects that number to grow.
ProPhase Labs of Doylestown was previously best known as the manufacturer of Cold-Eeze zing lozenges for cold sufferers. It sold the Cold-Eeze brand for $50 million in 2017 to Mylan.
In October, ProPhase (NASDAQ: PRPH) signed an agreement to acquire a North Jersey accredited laboratory owned by Confucius Plaza Medical Laboratory Corp. for $2.5 million. The 4,000-square-foot lab in Old Bridge — approved for a variety of medical tests, including Covid-19 and respiratory pathogen panel molecular tests — is now owned by ProPhase’s new subsidiary, ProPhase Diagnostics Inc.
"The opportunity is enormous, both to help people and to generate significant returns for our shareholders," said Ted Karkus, Prophase's chairman and CEO, when asked about the move into Covid testing.
ThinkEquity, a New York City boutique investment firm and division of Fordham Financial Management, just initiated coverage of ProPhase with a "buy" rating based largely on the growth potential of its Covid-19 saliva-based, diagnostic testing business.
The firm's target price for ProPhase's stock, which opened Wednesday at $14.52 per share, is $20.
ThinkEquity analyst Ashok Kumar, in his report initiating coverage of ProPhase, noted the company has indicated the capacity at its North Jersey lab is 10,000 tests per day. The company is also leasing space for a second lab in Garden City, New York, that is expected to be operational later this month and have the capacity for 50,000 tests per day to handle future demand.
"The company is currently at 1,500 tests per day, five days a week," Kumar stated in his report. "We are modeling 2,500 tests per day [during the first quarter of] 2021, increasing to 5,000 tests per day [for the rest of the year]."
Kumar further stated cash customers are paying $50 to $75 per test, with an average insurance payout of $100 per test. He estimated Prophase's 2021 Covid testing revenue at $84 million.
ProPhase posted revenue of $9.4 million during the first three quarters of 2020.
In his analysis, Kumar said he expects the company's legacy revenues from its contract manufacturing and supplement sales businesses to generate $17 million in sales for the company this year.
"For 2021, we forecast continued improvement in profitability along with strong sales growth," Kumar stated. "The success of the company’s new diagnostic testing labs business will depend on both attracting sufficient customers who choose to use the lab to process their test kits, and the ability to successfully operate a new business line."
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Karkus said he believes ThinkEquity's revenue forecast for ProPhase is conservative, and thinks the Covid testing business could generate "well over" $100 million in revenue this year.
"Our new goal is to be processing as many as 10,000 tests per day by March 31," Karkus said. "If we achieve just $30 profit per test, that’s $300,000 per day in daily pre-tax profit. This is an enormous goal and yet we believe that it is achievable."
Karkus said one of the company's top challenges is dealing with specimens that don’t have all of the required information on the collection devices. "This slows down the ability to record patient data, process the specimen and then report the results," he said. "This may not sound like a big challenge when you are processing 500 tests per day, but is incredibly challenging if processing 5,000 or 10,000 tests per day."
ProPhase is providing 24-hour turnaround times for test processing.
"Given all of the problems with turnaround times in the industry, often 3-7 days by the major labs, there is plenty of opportunity for those labs that can execute," Karkus said.
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