E-Sphere® Stool DNA Extraction Kit for clinical laboratories raises the bar for efficiency using standard laboratory equipment.

(Charlottesville, VA, May 16, 2011)

Phthisis Diagnostics, a rapidly growing biotechnology company developing a range of innovative molecular diagnostics technologies, announces the introduction of its first product, the E-Sphere® Stool DNA Extraction Kit.  The E-Sphere® Stool DNA Extraction Kit is the first product in Phthisis Diagnostics’ Simply Molecular® product line.

Laboratories have expressed their need for a faster, simpler method to purify genomic DNA from stool samples prior to PCR amplification and analysis.  The new kit answers the market need for speed with the added benefits of accuracy, improved cost effectiveness, reduced risk of sample contamination, and greater safety for lab technicians. The process requires only standard clinical laboratory equipment.

The novel E-Sphere® stool sample preparation method allows manual DNA extraction from 12 stool samples in less than 30 minutes. The streamlined process includes just 9 steps and minimizes sample contamination risk with only 2 sample transfers. Stool samples can be quickly processed within a biological safety cabinet.

“This new process provides significant time savings to clinical laboratories performing PCR analysis,” explains Crystal Icenhour, Ph.D., President and Director of Research at Phthisis Diagnostics. “We have developed the fastest and easiest manual process yet for stool DNA extraction, a notoriously difficult and unpleasant sample type. The speed of our entire process is comparable to the preparation time needed for many automated extraction systems. We have made the process very easy and reliable by removing the complexity seen with older methods”.

Advanced technology in the kit includes the high performance E-Sphere® Stool Enzyme, a thermostable reagent that digests fecal matter at 75°C during the 15 minute incubation stage. A further innovation is the proprietary E-Sphere® Clean-up Column which purifies the DNA.

Phthisis Diagnostics will present the kit for the first time in May at the American Society for Microbiology annual meeting (asm 2011 – booth #531) in New Orleans.  In the meantime, Phthisis Diagnostics invites interested laboratories to inquire about special evaluation pricing on this innovative kit.

The E-Sphere® Stool DNA Extraction Kit is developed and manufactured in the USA to ISO 9001 & ISO 13485 standards in a QSR & cGMP compliant facility, and is designated as a general purpose reagent.

About Phthisis Diagnostics

Phthisis (TYE-sis) Diagnostics is a rapidly growing biotechnology company developing the Simply Molecular® product catalog, a range of innovative molecular products designed for speed, accuracy, and ease of use. The Simply Molecular® catalog offers solutions for nucleic acid extraction, molecular diagnostics, and laboratory quality control.

Phthisis Diagnostics develops enzyme-based DNA extraction kits for rapid sample preparation prior to PCR applications in laboratories. The first product in this line will drastically reduce the time required to extract DNA from stool samples. This optimized workflow minimizes procedural steps, sample transfers, and potential for error.

Phthisis Diagnostics is also developing molecular diagnostic assays using PCR technology to detect intestinal pathogens associated with diarrheal disease, including Cryptosporidium, Giardia, Microsporidia, and others. For more information, visit www.phthisisdiagnostics.com.

About Crystal Icenhour, PhD

In 2006, Crystal Icenhour, PhD, became President and Director of Research for Phthisis Diagnostics, located in Charlottesville, VA. She is also an adjunct assistant professor at Duke University Medical Center’s Division of Infectious Diseases in their Department of Medicine. She has demonstrated business leadership in addition to her scientific capabilities and has expressed a goal of “bridging the translational gap between these two worlds.”

She has authored seven patents, has authored and co-authored 13 research articles and theses, and has been a prolific speaker and presenter at scientific conferences. She has served on review panels for the National Science Foundation and Environmental Protection Agency Small Business Innovation Research (SBIR) grants. Dr. Icenhour currently serves on the board of the Virginia Biotechnology Association and on the editorial board for the Journal of Microbiological Methods. She is a member of the Charlottesville Business Innovation Council, Sigma Xi, Medical Mycology Society of the Americas, National Postdoctoral Association, and the American Society for Microbiology.

About Molecular Diagnostics

Molecular diagnostics is defined as the use of DNA, RNA, and proteins to test for specific states of health or disease.  Molecular diagnostic methods have been increasingly used over the past ten years to improve the sensitivity and speed of diagnosis in infectious diseases. Although their routine use has been primarily limited to the detection of pathogens that are difficult to culture in vitro, ‘real-time’ methods, commercial kits, quantification, and automation will increase their use. Molecular diagnostic methods are now widely used for epidemiological fingerprinting of isolates of public health importance and increasingly being used by clinical laboratories to diagnose genetic and infectious disease.

Contact:
Dory Hulse, Media Relations
434-964-1037 or 434-242-1333 (mobile)
Dory1333@embarqmail.com

Charlottesville, VA – (May 9, 2011) – Phthisis Diagnostics, a molecular diagnostics research and development company, is pleased to announce the appointments of Jeffery LaFave as Sales & Marketing Manager and Elizabeth Pyle as Administration & Operations Director.

A specialist with over 30 years experience in the field of molecular diagnostic product sales and marketing, Mr. LaFave is a recognized biotechnology leader known for crafting the requisite strategic vision to achieve bottom-line results. He offers a unique blend of executive acumen, global sales, and marketing solutions. Jeff’s immediate focus will be the launch of the E-Sphere® Stool DNA Extraction Kit and participation in the American Society for Microbiology meeting in New Orleans, LA May 21 – 24, 2011.

As a consultant with Phthisis since 2007, Ms. Pyle has seen the company grow from a tiny one-person start-up to a thriving early-stage business with seven full-time employees now on the cusp of bringing its Simply Molecular® product line to the market place. Elizabeth brings 20+ years of business development experience to the strategic growth of Phthisis Diagnostics’ administrative and operational processes.

Crystal Icenhour, PhD, President and Director of Research at Phthisis Diagnostics stated: ”Our recent series A investments have allowed Phthisis to bring on two extraordinary new team members. I am pleased to hire our long-time business consultant Elizabeth Pyle. Liz adds significant value and structure to Phthisis. I am also excited that Jeff LaFave has joined the Phthisis team. Jeff has extensive sales and marketing experience in the field of molecular diagnostic products and brings a focused approach as we formally launch our first product, the E-Sphere® Stool DNA Extraction Kit at the ASM meeting in New Orleans later this month.”

About Phthisis Diagnostics

Phthisis (TYE-sis) Diagnostics is a rapidly growing biotechnology company developing the Simply Molecular® product catalog, a range of innovative molecular products designed for speed, accuracy, and ease of use. The Simply Molecular® catalog offers solutions for nucleic acid extraction, molecular diagnostics, and laboratory quality control.

Phthisis Diagnostics develops enzyme-based DNA extraction kits for rapid sample preparation prior to polymerase chain reaction (PCR) applications in laboratories. The first product in this line will drastically reduce the time required to extract DNA from stool samples. In addition to the improved accuracy for patient diagnosis and treatment, is the optimized workflow which minimizes procedural steps, sample transfers, and potential for error. This means greater efficiency for busy laboratories.

Phthisis Diagnostics is also developing molecular diagnostic assays using PCR technology to detect intestinal pathogens associated with diarrheal disease, including Cryptosporidium, Giardia, Microsporidia, and others. For more information, visit www.phthisisdiagnostics.com.

CONTACT:

Dory Hulse, Media Relations
434-964-1037 or 434-242-1333 (mobile)
Dory1333@embarqmail.com

Charlottesville, VA – (April 26, 2011)—Phthisis Diagnostics, Inc, announced today a fresh round of funding that will enable the company to immediately launch their first product, The E-Sphere® Stool DNA Extraction Kit, with another product in development  and available for launch in approximately 18 months.

The closing of the $450,000 Series A round of capital financing was led by Piedmont Angel Network (PAN – www.piedmontangelnetwork.com).  Other participates in the round were New Dominion Angels of Warrenton, VA and Center for Innovative Technology of Herndon, VA.  These new funds will be used to launch the E-Sphere® Stool DNA Extraction Kit. The R-Sphere™ diagnostic test line is scheduled to debut in late 2012.

“The Piedmont Angel Network is excited to have led the Series A round for Phthisis Diagnostics which will fund the launch of the company’s innovative line of molecular diagnostic products,” commented Andy Dreyfuss, PAN Fund Executive.  “As the rate of infectious diseases has increased in the United States over the past 15 years, doctors and laboratories have been under pressure to quickly, accurately, and cost-effectively diagnose incidents.  We believe that Phthisis Diagnostics has superior technology, an excellent management team, and the expertise to capitalize on the rapid growing use of molecular diagnostics to improve patient outcomes.”

“We are delighted to work with Piedmont Angel Network, New Dominion Angels, and Center for Innovative Technology on this investment,” stated Crystal Icenhour, PhD, President and Director of Research & Development for Phthisis Diagnostics.  “This funding will allow Phthisis to shift its focus from research and development to commercialization of its technologies.”

Phthisis Diagnostics will be attending the American Society for Microbiology (ASM) annual meeting on May 20-25, 2011 in New Orleans, LA (Booth #531), where The E-Sphere™ Stool DNA Extraction Kit  will be formally introduced.    “We are excited about attending this year’s ASM meeting,” commented Dr. Icenhour.  “Not only will we be participating as first-time exhibitors, introducing our innovative diagnostic product line Simply Molecular™, but three of our researchers will be presenting posters demonstrating data on current and future product development.”

Phthisis (TYE-sis) Diagnostics is a rapidly growing biotechnology company developing the Simply Molecular® product catalog, a range of innovative molecular products designed for speed, accuracy, and ease of use. The Simply Molecular® catalog offers solutions for nucleic acid extraction, molecular diagnostics, and laboratory quality control.

Phthisis Diagnostics develops enzyme-based DNA extraction kits for rapid sample preparation prior to polymerase chain reaction (PCR) applications in laboratories. The first product in this line will drastically reduce the time required to extract DNA from stool samples. In addition to the improved accuracy for patient diagnosis and treatment, is the optimized workflow which minimizes procedural steps, sample transfers, and potential for error. This means greater efficiency for busy laboratories.

Phthisis Diagnostics is also developing molecular diagnostic assays using PCR technology to detect intestinal pathogens associated with diarrheal disease, including Cryptosporidium, Giardia, Microsporidia, and others. For more information about Phthisis Diagnostics, please visit http://phthisisdiagnostics.com/.

CONTACT:

Dory Hulse, Media Relations
434-964-1037 or 434-242-1333 (mobile)
Email

Phthisis Diagnostics has been nominated as a 2011 Virginia Healthcare Innovator in the Medical Device category.  This innovation award is sponsored by the Virginia Department of Health and Human Resources, as well as a number of organizations devoted to innovation in the State of Virginia.

Finalists for this innovation award will be announced March 15, 2011, with finalists and winners will be recognized at an awards event at Lewis Ginter Botanical Gardens in Richmond, VA on March 29, 2011.

For additional information on the 2011 Virginia Healthcare Innovator Awards and the sponsors of this program, visit www.virginiahealthcareinnovators.org.

(Charlottesville, Virginia, 11/01/2010)   Phthisis Diagnostics, a rapidly growing biotechnology company developing a range of innovative molecular diagnostics products, has been awarded $280,000 in funding under the qualifying therapeutic discovery project (“QTDP”) program.  Established under Section 48D of the Internal Revenue Code, all applications have been reviewed by the Department of Health and Human Services (DHHS).

 “We are pleased that the IRS and DHHS have given us this positive evaluation,” states Crystal Icenhour, Ph.D., President and Director of Research. “These grants validate the importance of the research we are conducting at Phthisis Diagnostics and provide additional non-dilutive funding for our research and commercialization programs.”

Phthisis Diagnostics has already established a formidable track record in grant applications under the leadership of Dr Icenhour, having successfully competed for over $2.25M in NIH funding from the Small Business Innovation Research (SBIR) and other grant programs.

The QTDP program was established as a result of the Patient Protection and Affordable Care Act of 2010 to provide tax credits or grants to taxpayers with no more than 250 employees in an amount equal to 50% of eligible 2009 and 2010 expenses related to a qualifying therapeutic discovery project. The program targeted projects that show potential to produce new therapies to treat areas of unmet medical need or prevent, detect or treat chronic or acute diseases and conditions, reduce long-term health care costs in the United States, and create high value jobs.

Prior funding has enabled the company to ready its first product, the E-Sphere™ Stool DNA Extraction Kit, for commercialization in early 2011. Phthisis Diagnostics is also developing a range of assays for the rapidly growing molecular diagnostics market, a segment which uses advanced technology to detect DNA targets in specimens. Ongoing research includes a test to detect two pathogens, Cryptosporidium and Giardia, both contagious intestinal parasites which can cause dangerous and disruptive gastric infections in humans.

Phthisis Diagnostics is currently in the latter stages of a Series A funding round.

Contacts:

Phthisis Diagnostics                                       (434) 293-8180

Crystal Icenhour, Ph.D.                                

President, Director of Research                 

Rolf Taylor                                                         

Sales & Marketing Director                     

About Phthisis Diagnostics

Charlottesville based Phthisis (TYE-sis) Diagnostics is a rapidly growing biotechnology company developing the Simply Molecular ^TM product catalog, a range of innovative molecular diagnostics products designed for speed, accuracy, and ease of use. The Simply Molecular ^TM catalog offers solutions for DNA Extraction, Molecular Diagnostics, and Laboratory Quality Control.

Phthisis Diagnostics develops enzyme-based DNA extraction kits for rapid sample preparation prior to PCR applications in clinical laboratories. The first product in this line, the E-Sphere™ Stool DNA Extraction Kit will drastically reduce the time required to extract DNA from stool samples prior to testing for pathogens such as Clostridium difficile. This optimized workflow minimizes procedural steps, sample transfers, and potential for error.

Phthisis Diagnostics is also developing the R-Sphere^TM range of clinical molecular diagnostic assays using PCR technology to detect microbial pathogens associated with significant risk to public health, including Cryptosporidium, Giardia, Microsporidia, and Tuberculosis. Phthisis Diagnostics is also creating a Molecular Standard Library, reliable positive controls for selected microbial pathogens.

Dr. Crystal Icenhour was recently interviewed by GenomeWeb for an article in their June 03,2010 edition entitled “qPCR’s Big Bag of Tricks”.  Click on the following link to access this article:  qPCR’s Big Bag of Tricks.

For more information about GenomeWeb, visit www.genomeweb.com.

Phthisis Diagnostics recently attended the American Society for Microbiology 110th General Meeting held in San Diego, CA May 23rd through 27th.  This General Meeting consists of researchers, clinicians, and companies committed to improving clinical and environmental microbiology issues. 

Phthisis Diagnostics was represented by Dr. Crystal Icenhour, Mrs. Elizabeth Coleman, and Ms. Linh Nguyen.  Dr. Icenhour gave a presentation on Careers in Start Ups for the Special Interest Symposium on Non-Academic Career Tracks in Microbiology.  Dr. Icenhour also presented a poster on Phthisis’ lead product, B-Sphere™ Stool DNA Extraction kit.  Mrs. Coleman presented a poster on Phthisis’ intestinal parasite diagnostic, R-Sphere™ Crypto/Giardia Detect and Ms. Nguyen presented a poster on molecular standards.

For more information on Phthisis Diagnostics’ and its products, visit www.phthisisdiagnostics.com.  For additional information on the ASM 110th General Meeting, visit www.gm.asm.org.

The Phthisis Diagnostics Team at the ASM 110th General Meeting

Phthisis Diagnostics will be presenting at the University of Virginia Venture Summit.  The Second Annual UVA Venture Summit will be held March 25-26, 2010 in Charlottesville, VA.  This event  is ‘designed to interweave the creativity of university scholars and researchers, the innovation of venture capitalists, and the commitment of this diverse partnership to the entrepreneurial imperative in a global knowledge economy’.

Phthisis Diagnostics will be showcased in the Start-up Companies presentations, along with three other companies: ADial, ContraVac, and Privaris.  Additional information about the UVA Venture Summit can be found at www.virginia.edu/vpr/venture_summit.html.

Phthisis Diagnostics has been awarded a phase I SBIR award from the National Institutes of Health, National Institute of Allergy and Infectious Diseases.  This 12 month award will focus on developing a prototype for a molecular diagnostic for Microsporidia.  Microsporidia cause a cryptic enteric infection and will benefit from the development of an easy-to-use and sensitive diagnostic.  Dr. Crystal Icenhour will serve as Principal Investigator on this award with Elizabeth Coleman serving as Project Manager.

Phthisis Diagnostics has been awarded a phase I SBIR award from the National Science Foundation.  This 6 month award focuses on synthetic biology, creating synthetic standards for use in various areas such as water quality, clinical diagnostics, and basic research.  Dr. Crystal Icenhour will serve as Principal Investigator on this award with Brian Loyal serving as Project Manager.  “This award provides support for an exciting product line for Phthisis Diagnostics”, says Dr. Icenhour.

Additional information about the National Science Foundation can be found at: www.nsf.org.