PRESS ROOM

SSAN DIEGO, CA : True Diagnostics, Inc., a Point-of-Care diagnostic company located in Carlsbad, California, announced today that the Company has completed its pre-submission filing with the Food and Drug Administration (“FDA”) to request additional feedback for its planned 510(k) filing for the TrueDX™ TSH system. True Diagnostics is developing its TrueDX™ system designed to inform real-time treatment decisions for Point-of-Care clinicians.

The diagnostic industry has been evolving towards the Point-of-Care to meet the growing demands of patient care. Researchers project the global POCT market is expected to grow at a CAGR of around 8.4% over the next five years. Point-of-Care tests provide quicker results to make critical diagnostic and therapeutic decisions for both the provider and the patient. The TrueDX™ Platform Technology leverages a proprietary calibration assay and method that demonstrates improved standards for specificity, accuracy, stability and simplicity over traditional Point-of-Care methods.

“The challenges associated with obtaining CLIA-waived status for a medical diagnostic device are standards that we embrace with our product designs. Our management team’s experience and key partnerships will help us deliver on the potential opportunities growing within the Point-of-Care market,” said Jerry Lee, President and CEO of True Diagnostics. “True Diagnostics previously completed device approvals for its TrueDX-TSH test in Europe and China and we look forward to launching the TrueDX platform in the US,” Lee said.

About True Diagnostics

For the $21 billion point-of-care market, the power of the TrueDX™ Platform lies in its simplicity: tests have a 24-month shelf life; they do not require refrigeration; and laboratory quality results from small samples can now be available to clinicians in minutes. The TrueDX™ Platform’s simplicity, portability and affordability also allow it to be easily adopted into emerging markets. The platform’s flexible design additionally permits it to quickly commercialize a myriad of biomarkers discovered for cancer, autism, Alzheimer’s, diabetes, drugs of abuse, infectious diseases, cardiac health, traumatic brain injury, viral and bacterial infections and more. In essence, any biomarker utilizing traditional lab methods, such as an CLEIA, ELISA, or GC/MS can now be ported into a simple, fast, and portable assay which offers quick diagnosis and treatment at the point-of-care, point-of-incidence and remote-of-care settings.

For more information, contact:
Leo Liu
leo.liu@truediag.com
(888) 571-8597 Ext 700

SAN DIEGO, CA : True Diagnostics, Inc., a company dedicated to the discovery and development of innovative diagnostic solutions announced today that they have entered into a collaboration with Merck KGaA, Darmstadt, Germany, a world leader in providing CardioMetabolic Care. Under the agreement, True Diagnostics will collaborate with the biopharmaceutical division of Merck KGaA, Darmstadt, Germany which operates as EMD Serono in the United States and Canada to help improve and increase access to Thyroid Care in the People’s Republic of China. The partnership allows the companies to provide Medical Professionals with a new and meaningful point-of-care method for rapid screening hypothyroidism patients in minutes using only a small sample of whole-blood collected directly from the patient’s fingertip.

Under terms of the partnership, Merck KGaA will have the exclusive right to market and distribute in China True Diagnostics’ proprietary screening assay platform and associated consumables in the Thyroid Care market. True Diagnostics, Inc. received clearance in China from the China Food and Drug Administration (CFDA) for their TrueDX™ Platform and TSH (Thyroid Stimulating Hormone) test and along with Merck KGaA look forward to improving the diagnosis rate of hypothyroidism disease aimed at helping the approximately 76 million patients in China1 who suffer from hypothyroidism.

“We are extremely excited about our partnership with Merck in Darmstadt, Germany,” said Jerry Lee, President and Chief Executive Officer of True Diagnostics. “Through our combined efforts, we will not only be the first to provide a screening option for Medical Professionals, but also provide a technology platform that will eventually help lead to improve the overall efficiency for China’s Healthcare System.”

References
1. Weiping Teng, “Prevalence of Thyroid Disease in 10 cities in China”, The 9th annual meeting of Chinese Society Endocrinology

About True Diagnostics
For the $21 billion point-of-care market, the power of the TrueDX™ Platform lies in its simplicity: tests have a 24-month shelf life; they do not require refrigeration; and laboratory quality results from small samples can now be available to clinicians in minutes. The TrueDX™Platform’s simplicity, portability, and affordability also allow it to be easily adopted into emerging markets. The platform’s flexible design additionally permits it to quickly commercialize a myriad of new biomarkers discoveries for cancer, autism, Alzheimer’s, diabetes, drugs of abuse, infectious diseases, cardiac health, traumatic brain injury, viral and bacterial infections, and more. In essence, any biomarker utilizing traditional lab procedures, such as an ELISA or GC/MS methods can now be ported into a simple, fast, and portable assay which offers quick diagnosis and treatment at the point-of-care, point-of-incidence and remote-of-care settings. For more information, call (888) 571-8597 Ext. 702 or go to www.TrueDiagnostics.com For more information, call (888) 571-8597 Ext 702 or go to www.TrueDiagnostics.com

CONTACT:
True Diagnostics, Inc.
Communications Department
info@truediag.com
(888) 571-8597 Ext 702

SAN DIEGO, CA : True Diagnostics, Inc.™ (www.TrueDiagnostics.com), a company dedicated to the discovery and development of innovative diagnostic solutions, announced today it has received Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for its application covering quantitative testing method used for the TrueDX™ Platform. With this new technology, medical professionals and patients can now immediately perform multiple tests simultaneously using a finger-prick of blood – rather than wait days for test results from an intravenous blood draw. The allowed patent, entitled “Quantitative analyte assay device and method” has the earliest priority date of December 2008. The patent is expected to issue in the next few months. True Diagnostics retains an exclusive license to use, develop, and commercialize this patent.

This is the second Notice of Allowance covering the TrueDX™ Platform. The company also has separate pending international applications covering multiple regions worldwide.

Jerry Lee, President/CEO of True Diagnostics notes, “We are pleased to reach a major benchmark in our vision to bring a forward a generation of new tests. With our technology we can help apply this towards improving the way we diagnose, monitor and treat patients worldwide. We have the potential to increase testing specificity, reduce testing lead times, and simplify testing procedures using one diagnostic platform.“

About the CompanyFor the $21 billion point-of-care market, the power of the TrueDX™Platform lies in its simplicity: tests have a 24-month shelf life; they do not need refrigeration; and, laboratory quality results from small samples can now be available to doctors in minutes. The TrueDX™Platform’s simplicity, portability, and affordability also allow it to be easily adopted into emerging markets. The platform’s flexible design additionally permits it to quickly commercialize a myriad of new biomarkers discoveries for cancer, autism, alzheimer’s, diabetes, drugs of abuse, infectious diseases, cardiac health, traumatic brain injury, viral and bacterial infections, and more. In essence, any biomarker discovery utilizing traditional lab methods, such as an ELISA process, can now be developed into a simple, fast, and portable assay which can offer quick diagnosis and treatment at the point-of-care, point-of-incidence and remote-of-care settings.

For more information, call 760-683-9158 or go to www.TrueDiagnostics.com

CONTACT:
Jerry Lee, CEO
True Diagnostics, Inc.
jerry@TrueDiag.com
760-683-9158 (office)

SAN DIEGO, CA : True Diagnostics, Inc.™ (www.TrueDiagnostics.com) announces it has received a CE Mark for TrueDX™PSA, its quantitative PSA (Prostate Specific Hormone). With the TrueDX™PSA test doctors can immediately determine the PSA level in a patient with only a finger prick of blood – rather than wait days for lab results from an intravenous blood draw. This unique test enables doctors to gain access to diagnoses in minutes and immediately create an effective treatment plan. The Company has a CE mark for a qualitative PSA test, TrueCX™PSA, as a quick screen for other-the-counter use to determine PSA levels greater than 5.0. True Diagnostics is actively engaging distribution partners throughout all EU markets, with initial focus in Germany, UK, France, Italy and Spain.

This is the third regulatory clearance for the TrueDX™Platform with a CE Mark already for its TrueDX™TSH test, and an sFDA approval for TrueDX™TSH in China. The Company expects to run short clinical studies in the U.S. this year and further submit for CLIA-waive and 510k FDA clearances to market the TrueDX™Platform with its quantitative tests throughout the U.S.

Jerry Lee, President/CEO of True Diagnostics notes, “With our TrueDX™PSA, the Company provides general practitioners, urologists, and oncologists with a simple point-of-care tool they can use to measure their patients’ prostate health immediately. This year we expect to announce many more quantitative TrueDX™ tests for the market. We are currently in process of establishing a distribution network across all EU markets.”

About PSA (from the National Cancer Institute) Prostate-specific antigen, or PSA, is a protein produced by cells of the prostate gland. The PSA test measures the level of PSA in a man’s blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood. The blood level of PSA is often elevated in men with prostate cancer, and the PSA test was originally approved by the FDA in 1986 to monitor the progression of prostate cancer in men who had already been diagnosed with the disease. In 1994, the FDA approved the use of the PSA test in conjunction with a digital rectal exam (DRE) to test asymptomatic men for prostate cancer. Men who report prostate symptoms often undergo PSA testing (along with a DRE) to help doctors determine the nature of the problem. In addition to prostate cancer, a number of benign (not cancerous) conditions can cause a man’s PSA level to rise. The most frequent benign prostate conditions that cause an elevation in PSA level are prostatitis (inflammation of the prostate) and benign prostatic hyperplasia (BPH) (enlargement of the prostate). There is no evidence that prostatitis or BPH leads to prostate cancer, but it is possible for a man to have one or both of these conditions and to develop prostate cancer as well.

About the Company For the $21 billion point-of-care market, the power of the TrueDX™Platform lies in its simplicity: tests have a 24-month shelf life; they do not need refrigeration; and, laboratory quality results from small samples can now be available to doctors in minutes. The TrueDX™Platform’s simplicity, portability, and affordability also allow it to be easily adopted into emerging markets. The platform’s flexible design additionally permits it to quickly commercialize a myriad of new biomarkers discoveries for cancer, autism, alzheimer’s, diabetes, drugs of abuse, infectious diseases, cardiac health, traumatic brain injury, viral and bacterial infections, and more. In essence, any biomarker discovery utilizing traditional lab methods, such as an ELISA process, can now be developed into a simple, fast, and portable assay which can offer quick diagnosis and treatment at the point-of-care, point-of-incidence and remote-of-care settings.

For more information, call 760-683-9158 or go to www.TrueDiagnostics.com

CONTACT:
David Larson, CFO/COO
True Diagnostics, Inc.
2774 Loker AvenueWest, Carlsbad, CA 92008
david.larson@TrueDiag.com
760-683-9158 (office)
858-449-7085 (cell)

SAN DIEGO, CA : True Diagnostics, Inc.™ (www.TrueDiagnostics.com) has announced it has received a CE Mark to allow it to distribute its TrueDX Platform and quantitative TSH (Thyroid Stimulating Hormone) test in Europe. With the TrueDX Platform, doctors can immediately determine if a patient suffers from a hypoactive thyroid by using only a finger prick of blood. This unique test enables doctors and patients to gain access to diagnosis in minutes, create an effective treatment plan, while saving physicians’ time and patients cost and anxiety. True Diagnostics is actively engaging distribution partners throughout all EU markets, with initial focus in Germany, UK, France, Italy and Spain.

This is the second regulatory clearance for the TrueDX Platform with TSH test, having received sFDA approval for China in September 2011. True Diagnostics expects to run short clinical studies in the U.S. this summer and further submit for CLIA-waive and 510k FDA clearance to market the TrueDX Platform with quantitative TrueDX-TSH™ tests throughout the U.S.

What will the TrueDX Platform mean for doctors and patients seeking to more easily identify Hypoactive Thyroid? Hypothyroidism affects over 200 million people globally, more than people with diabetes. TSH is the fourth most requested blood test in America. Hypothyroidism is commonly undiagnosed and misdiagnosed with symptoms ranging from weight gain to depression, forgetfulness, hair loss, thinning and drying of skin, fatigue, loss of libido, feeling cold, constipation, and a pronounced goiter.

Jerry Lee, President/CEO of True Diagnostics, notes, “With this latest regulatory clearance, the Company has laid the foundation to begin standardizing a full range of diagnostic and monitoring tests that will provide instant results to doctors and patients and demand little training. With distribution partners already lined up and more coming soon, we expect initial shipments to Europe to begin within 60 days.”

The strength of the TrueDX Platform lies in its simplicity. tests have a 24-month shelf life. They do not need to be refrigerated. Laboratory quality results from small samples can now be available to doctors to review in minutes. The TrueDX Platform’s simplicity, portability, and affordability allow it to be easily adopted into emerging markets. The platform’s flexible design also permits it to stay ahead of potential competitors and quickly commercialize a myriad of new biomarkers discoveries for cancer, autism, alzheimer’s, diabetes, drugs of abuse, infectious diseases, cardiac health, traumatic brain injury, viral and bacterial infections, and more. In essence, any biomarker discovery utilizing traditional lab methods, such as an ELISA process, can now be developed into a simple, fast, and portable assay which can offer quick diagnosis and treatment right in the physician’s office.

About the Company True Diagnostics, Inc. creates simple diagnostic solutions for the $46 billion medical point-of-care, sterility assurance, animal health, and food processing markets. After 30 years in the global medical diagnostic field, the inventor of the home pregnancy test created the TrueDX Platform which can measure the severity of any medical condition (using only a finger prick of blood, small urine or saliva sample, toxins, surface bacteria, and more), provide results in minutes (not days), and is completely portable. The TrueDX Platform takes point-of-care, point-of-incidence, and remote-of-care applications out of the lab to provide more flexible treatment that can begin immediately. The TrueDX Platform creates unique and powerful opportunities for new diagnostic solutions through its ability to: 1) quickly bring new diagnostic tests to market; and, 2) open new geographic and application opportunities.

For more information, call 760-683-9158 or go to www.TrueDiagnostics.com

CONTACT:
David Larson, CFO/COO
True Diagnostics, Inc.
2774 Loker AvenueWest, Carlsbad, CA 92008
david.larson@TrueDiag.com
760-683-9158 (office)
858-449-7085 (cell)

SAN DIEGO, CA : True Diagnostics, Inc.™ (www.TrueDiagnostics.com) announces the Company has received sFDA clearance for its TrueDX™ Platform with its first test for TSH and expects shipments to China to begin before the end of the year. The TrueDX Platform produces quantitative results using LFIA (Lateral Flow Immunoassay) technology and measures the severity of conditions, produces results in minutes from a finger prick of blood (or small urine or saliva sample), and is portable. This allows point-of-care professionals to begin patient treatment immediately. With the TrueDX Platform, the Company can effectively take any biomarker, quickly commercialize it to produce quantitative results, and bring it to market.

Jerry Lee, President/CEO, stated, “After years of development, we broke the code on producing quantitative results in minutes on an LFIA platform which can handle boundless applications. We also expect to make an announcement soon concerning a significant distribution partnership which clarifies how we are entering the China market with our new TrueDX Platform with TSH tests.”

About the Company
True Diagnostics, Inc. creates diagnostic solutions for the $18 billion point-of-care IVD market. After 30 years in the global medical diagnostic field, the inventor of the pregnancy test created the TrueDX Platform which can measure the severity of any medical condition (using only a finger prick of blood, small urine or saliva sample, toxins, surface bacteria, and more), provide results in minutes (not days), and is portable. The TrueDX Platform takes point-of-care, point-of-incidence, and remote-of-care applications out of the lab to allow patient treatment to begin immediately. The flexibility of the TrueDX Platform creates unique and powerful opportunities for new diagnostic solutions through its ability to: 1) quickly bring new diagnostic tests to market; and, 2) open new geographic and application markets.
For more information, call 760-683-9158 or go to www.TrueDiagnostics.com

Contact:
Jerry Lee, President/CEO
jerry@TrueDiag.com

FOR IMMEDIATE RELEASE: True Diagnostics, Inc.™ (www.TrueDiagnostics.com) announces that Dr. Mark Stearns has joined the Company’s Scientific Advisory Board. Dr. Stearns is a tenured Professor in the Department of Pathology and Laboratory Medicine at Drexel University College of Medicine (DUCOM) in Philadelphia. He is the Director of Research and Head of the Prostate Cancer Research Program at DUCOM. His group has published over 100 peer reviewed papers on prostate cancer and developed a strong research program focused on drug discovery targeting metastatic prostate cancer. Dr. Stearns is also the founder and Chief Scientific Officer of Macroarray Technologies LLC, a biotech company involved in the development of diagnostic markers for prostate cancer. Dr. Stearns group’s long term focus is to develop a cure for metastatic prostate cancer.

Jerry Lee, President/CEO stated, “We are very pleased and fortunate to have Dr. Stearns join our Scientific Advisory Board. His passion for developing a cure for prostate cancer coincides directly with diagnostic tests for prostate health we have planned for our TrueDX™ Platform. We look forward to his involvement with our development activities as we continue to commercialize biomarkers onto our new TrueDX Platform.”
Dr. Stearns added, “The promise of proper medical treatment all starts with proper diagnosis. That’s exactly what they’re doing at True Diagnostics and I’m excited to be a part of helping to shape their direction.”

About the Company
True Diagnostics, Inc. creates diagnostic solutions for the $18 billion point-of-care IVD market. After 30 years in the global medical diagnostic field, the inventor of the pregnancy test created the TrueDX Platform which can measure the severity of any medical condition (using only a finger prick of blood, small urine or saliva sample, toxins, surface bacteria, and more), provide results in minutes (not days), and is portable. The TrueDX Platform takes point-of-care, point-of-incidence, and remote-of-care applications out of the lab to allow patient treatment to begin immediately. The flexibility of the TrueDX Platform creates unique and powerful opportunities for new diagnostic solutions through its ability to: 1) quickly bring new diagnostic tests to market; and, 2) open new geographic and application markets.

For more information, call 760-683-9158 or go to www.TrueDiagnostics.com

Contact:
Jerry Lee, President/CEO
jerry@TrueDiag.com

– (www.TrueDiagnostics.com) presented its business plan and demonstrated its new disruptive technology, TrueDX™, at the San Diego Investment Conference held on December 4, 2010 at the Torrey Pines Hilton in San Diego. True Diagnostics joined nine other companies in presenting their companies to a group of approximately 100 investors, broker/dealers and investment banks.
True Diagnostics creates powerful and affordable solutions for the $18 billion point-of-care IVD market through its new disruptive technology packaged in its TrueDX™ platform. Coupled with its quantitative tests for life threatening and quality of life medical conditions – rather than sending patients to a lab for blood work, with a single pin prick of blood, physicians can diagnose the severity of patient problems during a first office visit and begin treatment immediately.
Planned products include diagnosing traumatic brain injury, pre-malignant tumors, colon cancer, prostate health, infectious diseases, fertility, thyroid health, cholesterol, allergies, diabetes, and more. True Diagnostics seeks $2.5 million to expand its R&D activities, field test, receive FDA approval and launch its products into the global market.

CONTACT:
David Larson, CFO/COO
True Diagnostics, Inc.
2774 Loker AvenueWest, Carlsbad, CA 92008
dave.larson@TrueDiag.com
760-683-9158 (office)
858-449-7085 (cell)