CardioDx Expands Patient Access to the Corus(R) CAD Test Through National Agreement With Quest Diagnostics

CardioDx Expands Patient Access to the Corus(R) CAD Test Through National Agreement With Quest Diagnostics

CardioDx Also Separately Raises $20 Million in New Financing to Support the Company’s Commercial Growth and Operations

Redwood City, CA, September 16, 2015 – CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, today announced a national specimen-draw agreement with Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, that will expand patient and clinician access to the Corus CAD lab-developed blood test for aiding the assessment of obstructive coronary artery disease (CAD)*.

Under a multi-year agreement, clinicians will be able to order blood draws on patients for testing through Quest’s approximately 2,200 patient service centers and 4,000 phlebotomists in physician offices in the United States. Samples will be forwarded to CardioDx’s CLIA-certified laboratory (in Redwood City, Calif.) for testing.

CardioDx Raises $35 Million in Equity Financing

– Funding Slated for Further Commercial Deployment of the Corus® CAD Blood Test and Continued Development of Next Generation Products –
REDWOOD CITY, CA – December 18, 2014 – CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, today announced the close of $35 million in total equity financing. Alberta Investment Management Corporation (AIMCo) participated in this round together with the company’s existing investors.

CardioDx Announces Results of Study Demonstrating the Benefits of the Corus CAD Gene Expression Test Use in an African American Patient Population

– Patients with Low Corus CAD Scores Had a 95% Decreased Rate of Referral for Advanced Cardiac Testing Versus Patients with Elevated Corus CAD Scores –

REDWOOD CITY, Calif. – [October 20, 2014] – CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, today announced the presentation of the study, “The Use of a Gene Expression Score Showed Clinical Utility in Evaluating African Americans Presenting with Symptoms Suggestive of Obstructive Coronary Artery Disease in a Primary Care Practice,” at the 36th Annual North American Meeting of the Society for Medical Decision Making, taking place from Oct. 18-22 in Miami.

CardioDx Announces Aetna and Coventry Health Coverage for Corus® CAD Gene Expression Test

– Blood-Based Test Has Potential to Improve Quality of Care and Lower Costs of Evaluation of Obstructive Coronary Artery Disease –
REDWOOD CITY, Calif. – [July 7, 2014] – CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, confirmed today that Aetna has established a clinical policy for the company’s Corus® CAD gene expression test. With this decision, the Corus CAD gene expression test is eligible for coverage among Aetna and Coventry Health members. Aetna considers the Corus CAD gene expression test medically necessary for evaluation of non-diabetic adults with chest pain or anginal equivalent symptoms who have no history of obstructive coronary artery disease.

New Study Results Further Reinforce that the Corus® CAD Test Helps Primary Care Clinicians Make Effective Referral Decisions for Patients with Suspected Obstructive Coronary Artery Disease

– Patients with a Low Corus CAD Score had 94% Reduced Odds of Referral to a Cardiologist –

– REGISTRY I Study Results Add to the Established Evidence Base Supporting the Clinical Utility of the Corus CAD Gene Expression Test in Real-World Clinical Practice –

PALO ALTO, Calif. – [May 05, 2014] – CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, today announced the publication of the REGISTRY I study, which examined the assessment of non-acute chest pain and related symptoms that may be suggestive of obstructive coronary artery disease (CAD) in the primary care setting with the Corus® CAD blood-based gene expression test. The study, published online in the American Journal of Medical Quality in May 2014, found a strong association between cardiac referral rates by low (≤15) and elevated (>15) Corus CAD score groups, with only 6% (10/167) of the low Corus CAD score patients versus 70% (122/175) of the elevated Corus CAD score patients being referred for further cardiac evaluation (P < .0001). Corus CAD is the first and only commercially available blood-based gene expression test that provides a current-state assessment of obstructive CAD in non-diabetic patients presenting with typical or atypical symptoms. With a 96% negative predictive value and 89% sensitivity, Corus CAD can help clinicians accurately rule out obstructive CAD as the source of their patients’ symptoms, so that they may investigate other non-cardiac causes.

Study Finds the Corus® CAD Gene Expression Blood Test Influenced Primary Care Decision- Making in the Assessment of Patients with Suspected Obstructive Coronary Artery Disease

– IMPACT-PCP Study Results Reinforce the Clinical Utility of Corus CAD in the Primary Care Setting, Where Almost 8,000 Patients Present With Non-Acute Chest Pain and Related Symptoms Every Day –

– Clinicians Modified Their Diagnostic Strategy in 58% of Patients Following a Corus CAD Test Score –

PALO ALTO, Calif. – March 10, 2014 – CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, today announced the publication of the IMPACT-PCP (Investigation of a Molecular Personalized Coronary Gene Expression Test on Primary Care Practice Pattern) trial reinforcing the value of Corus® CAD as an initial diagnostic test for the evaluation of patients presenting with non-acute symptoms suggestive of obstructive coronary artery disease (CAD) in the primary care setting. The study appears in the March 2014 issue of the Journal of the American Board of Family Medicine.

New Data Highlight Value of Corus® CAD in Reducing Unnecessary Cardiac Testing and Costs for Women with Symptoms Suggestive of Obstructive Coronary Artery Disease

Corus® CAD Has Potential to Reduce Cardiac Diagnostic Costs in Women by More Than $500 per Patient

PALO ALTO, Calif., Oct. 10, 2013 /PRNewswire/ — CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, today announced results of two studies indicating that Corus® CAD, a blood-based gene expression test, may help reduce unnecessary cardiac testing and costs by aiding clinician decision-making in the evaluation of women with symptoms suggestive of obstructive coronary artery disease (CAD). The studies were presented at The North American Menopause Society (NAMS) 2013 Annual Meeting, taking place October 9-12, 2013 in Dallas, TX.

CardioDx Press Release – CardioDx Honored as One of FierceMedicalDevices’ Fierce 15 Most Promising Private Companies

PALO ALTO, Calif. – Oct. 2, 2012 – CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced that the company has been named one of FierceMedicalDevices’ Fierce 15 most promising privately held medical device and diagnostics companies in the world. FierceMedicalDevices editors chose this year’s winners based on their top management teams, notable financial backing, promising technologies and market opportunities. The award was presented today at an event that took place during AdvaMed 2012: The MedTech Conference in Boston, Mass.

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CardioDx Honored as One of FierceMedicalDevices’ Fierce 15 Most Promising Private Companies

PALO ALTO, Calif. – Oct. 2, 2012 – CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced that the company has been named one of FierceMedicalDevices’ Fierce 15 most promising privately held medical device and diagnostics companies in the world. FierceMedicalDevices editors chose this year’s winners based on their top management teams, notable financial backing, promising technologies and market opportunities. The award was presented today at an event that took place during AdvaMed 2012: The MedTech Conference in Boston, Mass.

CardioDx Completes $58 Million Equity Financing

 

CardioDx Completes $58 Million Equity FinancingProceeds to Support Commercial Expansion of Corus CAD and New Product Development

PALO ALTO, Calif. – August 27, 2012 – CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, today announced the completion of a $58 million two-tranche equity financing. The financing included Temasek, an Asia investment company based in Singapore; and existing investors Longitude Capital; Artiman Ventures; Kleiner, Perkins, Caufield & Byers; J.P. Morgan; Mohr Davidow Ventures; TPG Biotech; Intel Capital; Acadia Woods Partners; Bright Capital; the venture arm of RU-COM; Pappas Ventures; DAG Ventures; Asset Management Group; and GE Capital. All previous investors participated in the round.

Proceeds from the financing will be used to support the commercial expansion of Corus® CAD, the only clinically validated gene expression test for obstructive coronary artery disease, and to develop additional genomic diagnostics in the field of cardiovascular disease.

“This funding positions CardioDx well to capitalize on the significant opportunity to improve the diagnosis of the millions of patients who visit their physicians with symptoms suggestive of obstructive coronary artery disease each year,” said David Levison, the company’s President and Chief Executive Officer. “The favorable Medicare coverage decision that we received earlier this month is a significant milestone that further validates the clinical benefit of and economic rationale for Corus CAD. This additional capital will help us expand our sales force in the U.S., further broaden reimbursement coverage, and support continued investments in research and development of new products.”

CardioDx recently announced that Palmetto GBA, a national contractor that administers Medicare benefits, has established coverage for the Corus CAD gene expression test for the evaluation of patients presenting with typical and atypical symptoms suggestive of coronary artery disease. With this decision, the Corus CAD gene expression test is now a covered benefit for more than 40 million Medicare enrollees in the U.S.

Studies have shown that typical and atypical presentations of stable chest pain account for up to two percent of outpatient office visits each year in the U.S., which equates to up to three million patients per year in the Corus CAD intended-use population. However, a study of nearly 400,000 patients published in The New England Journal of Medicine in 2010 reported that as many as 62 percent of stable patients who undergo elective invasive angiographic procedures are found to have no obstructive coronary artery blockage, despite broad usage of prior noninvasive imaging. The authors concluded that current modalities used to identify patients for elective invasive angiography to diagnose obstructive coronary artery disease have limitations, and that better methods are needed for patient risk stratification.

As much as $5 billion is spent on noninvasive testing, imaging and elective invasive angiography in the Corus CAD intended-use population annually in the U.S.