First moderate-complexity Simplexa™ assay developed through funding by U.S. Department of Health and Human Services’ BARDA BAA program for public health preparedness

Cypress, Calif., and Saint Paul, Minn. — October 9, 2012 – Focus Diagnostics, a business of Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic testing, information and services, and 3M, a global diversified technology company (NYSE: MMM), today announced that the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance and CLIA moderate-complexity categorization to the Simplexa Flu A/B & RSV Direct test on the 3M™ Integrated Cycler.

The new test aids in the qualitative detection and differentiation of RNA of influenza A and B viruses and respiratory syncytial virus (RSV), common causes of respiratory illness. Focus Diagnostics, maker of the Simplexa™ brand of molecular test kits, and 3M™, maker of the 3M Integrated Cycler technology, developed the test through an exclusive global collaboration. The collaboration, formed in 2009, has produced several Simplexa molecular tests, including the first FDA-cleared commercial test for the influenza A H1N1 (2009) virus.

The Simplexa Flu A/B & RSV Direct molecular test is the first moderate-complexity molecular test from the Focus Diagnostics’ Simplexa product line, significantly broadening potential clinical access to the Simplexa/3M technology. Moderate complexity laboratories, defined by the Clinical Laboratory Improvement Amendments (CLIA), include certain types of physician’s offices, community hospitals, health clinics and integrated delivery networks. These facilities typically lack the personnel and technology to perform high-complexity molecular diagnostic tests. Since the test can be performed in these moderate complexity labs, patient results may be obtained readily to help speed therapeutic decisions.

“The future of influenza and all respiratory virus testing is molecular diagnostics, given its potential for high sensitivity and fast reporting of test results, which are essential for patient management,” said Jay M. Lieberman, M.D., medical director, infectious diseases, for Quest Diagnostics and Focus Diagnostics. “The clearance and moderate complexity categorization of the Simplexa test on the 3M Integrated Cycler signifies an important step forward in expanding access to near-patient molecular testing, potentially helping clinicians to make better decisions for their patients.”

The new Simplexa test was developed with funding from The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. It supports the development of new technologies with potential to be effective medical countermeasure products for public health emergency threats. BARDA awarded a .9 million contract for the test’s development.

“We are pleased to be part of this development that brings near-patient quality molecular testing to localized healthcare settings, and see it as evidence that public-private collaborations can produce important medical technologies” said Tom Cole, global marketing manager for 3M Infection Prevention Division. “The availability of this test to a broad swath of healthcare professionals in the U.S. will no doubt advance the diagnosis and management of many patients this coming Flu/RSV season.”

Influenza and RSV are contagious respiratory illnesses caused by viral infections. While influenza and RSV produce relatively mild disease in most healthy individuals, they may cause severe respiratory disease or death in certain populations, including young children and older adults.

Simplexa Flu A/B & RSV Direct test on the 3M™ Integrated Cycler

The Simplexa Flu A/B & RSV test kit is intended for use on the 3M Cycler for the in vitro qualitative detection and differentiation of RNA of influenza A and B viruses and the respiratory syncytial virus (RSV) in nasopharyngeal swabs. The test does not require the time-consuming nucleic extraction process required by many molecular tests, and can be performed and produce results within an hour.
The Simplexa Flu A/B & RSV Direct is now available in the United States. It was CE marked for distribution in Europe in 2011.

About Focus Diagnostics and Simplexa™

Focus Diagnostics, a business of Quest Diagnostics, develops and manufactures the Simplexa line of molecular test products operating on the 3M™ Integrated Cycler, a compact, portable testing platform, as part of an exclusive global collaboration with 3M (MMM). Simplexa was the first test kit to be FDA cleared for aiding in the detection and differentiation of the 2009 H1N1 influenza virus, in May 2010. Additional Simplexa tests aid in the detection and differentiation of Clostridium difficile, Bordetella pertussis and parapertussis, Cytomegalovirus, Epstein Barr virus and BK virus. The Simplexa/3M technology has won two several industry awards for medical innovation, including prestigious Medical Design Excellence Awards (MDEA) in 2012 and 2011.

In addition to Simplexa, Focus Diagnostics’ products sold worldwide include HerpeSelect® type-specific HSV serology and West Nile Virus DxSelect™.

To learn more about or order Simplexa and other Focus Diagnostics tests, please contact Focus Diagnostics at 800-445-0185 (U.S.) or +49-6026-9499540 (Europe), or visit www.Focusdx.com.

About 3M

3M captures the spark of new ideas and transforms them into thousands of ingenious products. Our culture of creative collaboration inspires a never-ending stream of powerful technologies that make life better. 3M is the innovation company that never stops inventing. With billion in sales, 3M employs 84,000 people worldwide and has operations in more than 65 countries. For more information, visit www.3M.com or follow @3MNews on Twitter.

The Simplexa Flu A/B & RSV Direct test on the 3M™ Integrated Cycler project has been funded in whole or in part with Federal funds from Biomedical Advanced Research and Development Authority, Department of Health and Human Services, under Contract No. HHSO100201000049C.

Simplexa™ Direct molecular chemistry win marks back-to-back MDEA Awards for diagnostic innovation

Cypress, Calif., August 13, 2012 – Focus Diagnostics Inc., the infectious disease diagnostics business of Quest Diagnostics, today announced that its Simplexa™ Direct Chemistry technology won a bronze award in the in vitro diagnostics category at the 2012 MDEA awards ceremony held May 23. Focus Diagnostics manufactures the Simplexa™ Direct line of molecular test products for use on the 3M™ Integrated Cycler as part of an exclusive global collaboration with 3M (MMM).

This marks the third accolade for the Simplexa/3M technology since its 2009 marketplace debut. In 2011, the Simplexa/3M technology won a bronze Edison Award for new science and medical diagnostic product, based on criteria that included technological innovation and marketplace success, and a gold MDEA award for in vitro diagnostic innovation.

“Receiving back-to-back MDEA awards for the Simplexa chemistry showcases our commitment to providing laboratories with the tools they need to bring sensitive and timely molecular testing closer to the patient,” says John Hurrell, General Manager, Focus Diagnostics, Inc. “Building upon our lab experience, the Simplexa Direct test menu is designed using our proprietary chemistry which eliminates the need for nucleic acid extraction, a step that typically takes up to 90 minutes.”

The MDEA competition recognizes advances in the design of medical products. Presented by UBM Canon, MDEA award winners are selected by an impartial jury on criteria that include design and engineering features that improve healthcare delivery, innovative use of materials and components, and functional innovations that change traditional medical attitudes or practices or offer significant use-related improvements.

Simplexa tests run on the 3M Integrated Cycler, a compact, portable testing platform which can provide test results in as few as 60 minutes. In 2012, Simplexa C.difficile Universal Direct and Simplexa Flu A/B & RSV Direct were both FDA cleared. In May 2010, Simplexa was the first test kit to be FDA cleared for aiding in the detection and differentiation of the 2009 H1N1 influenza virus. Several other Simplexa branded tests, including Dengue, Epstein Barr Virus, Cytomegalovirus and BK viruses, are CE marked and distributed in Europe.

About Focus Diagnostics
Focus Diagnostics, Inc. is an infectious disease diagnostics company, providing infectious disease reference laboratory services to hospitals and laboratories nationwide, and manufacturing and distributing diagnostic products worldwide. Focus Diagnostics develops innovative tests and products to assist physicians in diagnosing infectious diseases, and often provides the first diagnostic tests in the U.S. for emerging diseases, such as West Nile virus and SARS. HerpeSelect® type-specific HSV serology and West Nile Virus DxSelect™ are top-selling Focus Diagnostics products used in laboratories worldwide. Focus Diagnostics is a wholly owned subsidiary of Quest Diagnostics. Visit FocusDx.com.

Test eliminates nucleic-acid sample extraction, for faster results

MADISON, N.J. and CYPRESS, Calif., April 11, 2012 – Quest Diagnostics  (NYSE: DGX), the world’s leading provider of diagnostic testing, information and services, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to its Simplexa C. difficile Universal Direct Test on the 3M™ Integrated Cycler. 

The test, from the company’s Focus Diagnostics business, is intended to aid in the diagnosis of Clostridium difficile-associated disease, one of the most common and dangerous acquired infections in healthcare settings. It uses a proprietary technique to eliminate the time consuming nucleic-acid sample extraction process required by many other molecular tests, for potentially faster results reporting for hospitals and clinical laboratories.

Simplexa tests, running on the 3M™ Integrated Cycler, employ real-time polymerase chain reaction (RT-PCR) to qualitatively detect viruses, bacteria and other analytes. The Simplexa C. difficile Universal Direct test is performed on liquid or unformed human stool samples and detects the toxin B gene (tcdB) of C. difficile, including NAP1. The test uses a proprietary chemistry that eliminates the need for nucleic-acid extraction. Using the Simplexa test, hospital and other labs may complete the entire testing process in about an hour.

C. difficile-associated disease is a common and sometimes fatal healthcare-associated infection that causes diarrhea and other intestinal problems. As many as 14,000 people die of C. difficile-associated disease in theUnited States each year, according to the U.S. Centers for Disease Control and Prevention. 

“Detecting and containing C. difficile associated disease is one of the greatest clinical challenges in today’s healthcare environment,” said Jay M. Lieberman, M.D., medical director, infectious disease, for Quest Diagnostics and Focus Diagnostics.  “Fast, reliable PCR tests that are highly specific and sensitive in the detection of the tcdB gene, a toxin-B producing gene of C. difficile, are essential for identifying and treating this infection as well as containing its spread.”

With the FDA clearance, the Simplexa C. difficile Universal Direct Test on the 3M Integrated Cycler is immediately available in theUnited States. Focus Diagnostics launched the test inEurope during the second quarter of 2011.

About Simplexa™

Focus Diagnostics, a wholly-owned business of Quest Diagnostics, develops and manufactures the Simplexa line of molecular test products operating on the 3M™ Integrated Cycler, a compact, portable testing platform, as part of an exclusive global collaboration with 3M™.  Simplexa was the first test kit to be FDA cleared for aiding in the detection and differentiation of the 2009 H1N1 influenza virus, in May 2010. Additional FDA-cleared Simplexa tests aid the detection of influenza A and B and respiratory syncytial virus. Several other Simplexa-branded tests, including for Clostridium difficile, Epstein Barr and BK viruses, are CE marked and distributed in Europe. In 2011, the Simplexa/3M technology won a gold Medical Design Excellence Award in the in vitro diagnostics category and an Edison Award for new science and medical diagnostic product.

To learn more about or to order Simplexa and other Focus Diagnostics tests, please contact Focus Diagnostics at 800-445-0185 (U.S.) or +49-6026-9499540 (Europe), or visit SimplexaDx.com or FocusDx.com.

About Quest Diagnostics

Quest Diagnostics is the world’s leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at QuestDiagnostics.com. Follow us at Facebook.com/QuestDiagnostics and Twitter.com/QuestDX.

Quest, Quest Diagnostics, Simplexa and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics.

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