FDA Issues Another Emergency Use Authorization for Commercial H1N1 Flu Test to Quest Diagnostics' Focus Diagnostics

FDA Issues Another Emergency Use Authorization for Commercial H1N1 Flu Test to
Quest Diagnostics' Focus Diagnostics
Test runs on the 3M Integrated Cycler; Reflects first Simplexa(TM) branded
molecular test kit from Focus Diagnostics

MADISON, N.J., Oct. 16 /PRNewswire-FirstCall/ -- The U.S. Food and Drug
Administration (FDA) today issued a second emergency use authorization (EUA)
to Focus Diagnostics, the infectious disease diagnostics business of Quest
Diagnostics Incorporated (NYSE: DGX), for its 2009 H1N1 influenza virus test.
With the EUA, Focus Diagnostics is the only company in the U.S. to offer test
kits for detecting the pandemic 2009 H1N1 virus that the FDA has authorized
for emergency use by CLIA high-complexity labs, which include certain hospital
and regional labs. The test allows clinicians to quickly and definitively
identify infected patients, differentiating from those who have similar
symptoms.

The new EUA authorizes Focus Diagnostics to market and offer its Simplexa(TM)
Influenza A H1N1 (2009) test for use on the 3M(TM) Integrated Cycler from 3M
(NYSE: MMM) to CLIA high complexity laboratories for the duration of the
emergency. The 3M Integrated Cycler is a microfluidic molecular diagnostic
testing system and is not FDA cleared or approved. Used on the 3M platform,
the test can provide increased capacity for 2009 H1N1 influenza virus testing
to a wide range of CLIA-high complexity laboratories, including many
hospitals, coping with a surge in testing demand.

The new test offering is one outgrowth of an exclusive global distribution
agreement formed between Focus Diagnostics and 3M under which Focus will
develop and offer its first line of molecular diagnostic test kits, to be sold
under the Simplexa brand name, on the 3M Integrated Cycler. The 2009 H1N1
influenza test kit is the first offering from the Simplexa product line, and
the company plans to launch additional Simplexa test kits on the 3M Integrated
Cycler for infectious diseases in 2010.

"FDA's EUA for our new Simplexa H1N1 test on the 3M Integrated Cycler is a
major advance for 2009 H1N1 influenza testing," said Jon R. Cohen, M.D.,
senior vice president and chief medical officer, Quest Diagnostics. "Until
now, many CLIA-high complexity labs didn't have the technology, space or
expertise to perform molecular testing for the 2009 H1N1 flu virus. Our
relationship with 3M means that not only will more labs be able to perform
this type of testing, but they will also be able to fulfill higher levels of
testing demand. Expanded lab capability may be critical to the nation's
management of increased 2009 H1N1 testing this winter."

"Our exceptional collaboration with Focus Diagnostics underscores 3M's
commitment to leading the industry in introducing new technologies in clinical
diagnostics," said Debra Rectenwald, vice president, general manager, 3M
Infection Prevention Division. "We are excited that Focus Diagnostics will be
able to implement a real-time molecular technology that can improve the speed
and meet the demand for H1N1 testing."

Quest Diagnostics' Focus Diagnostics has a track record of being first to
market with new laboratory testing services for emerging infectious diseases.
On July 24, 2009, FDA announced that it had issued its first emergency use
authorization for a commercial 2009 H1N1 influenza virus test to Focus
Diagnostics for a laboratory developed test it had launched in May 2009. This
EUA was issued for the test running on equipment from Roche and Applied
Biosystems.

The Focus Diagnostics Simplexa(TM) Influenza A H1N1 (2009) test, which employs
real-time polymerase chain reaction (PCR), qualitatively detects RNA of the
2009 H1N1 flu virus in a patient's nasal or nasopharyngeal specimens. The test
targets a separate region of the hemagglutinin gene of the 2009 H1N1 influenza
virus to differentiate the presence of the 2009 H1N1 flu virus from seasonal
human influenza A virus.

The 3M Integrated Cycler is an instrument offering real-time polymerase chain
reaction (PCR) technology that provides results in 30-75 minutes. The compact
instrument utilizes advanced data management software to help laboratories
process, store and transfer data quickly and effectively. In addition, the
instrument has a small laboratory footprint at approximately 12 inches high
and 12 inches deep, and can process up to 96 samples per run.

"Our reference laboratories typically report results within 24 hours of
receipt of specimen," said John G. Hurrell, PhD, vice president and general
manager, Focus Diagnostics. "With the Simplexa test on the 3M Integrated
Cycler, a typical CLIA high-complexity laboratory can generate results within
hours, considerably reducing time spent to send a specimen to an outside lab.
Faster turnaround time can aid in clinical management of the patient and allow
hospitals to segregate infected patients from other high-risk individuals."

Quest Diagnostics performs H1N1 flu testing using the Focus Diagnostics test
authorized for emergency use by FDA in July at its Focus Diagnostics
laboratory in Cypress, CA, as well as at its Nichols Institute laboratories in
San Juan Capistrano, CA, and Chantilly, VA, and its Specialty Laboratory in
Valencia, CA.

For more information about Quest Diagnostics and influenza testing options,
please visit www.QuestDiagnostics.com/2009H1N1 or www.FocusDx.com/2009H1N1.

About the FDA's Emergency Use Authorization
The FDA has not cleared or approved any tests for the identification of the
2009 H1N1 influenza virus. The emergency use authorization authority allows
the FDA, based on the evaluation of available data, to authorize the use of
unapproved and uncleared medical products or unapproved or uncleared uses of
approved or cleared medical products following a determination and declaration
of emergency, provided certain criteria are met. An EUA only authorizes use
for the duration of the declaration of emergency, which is currently set to
expire on April 26, 2010, unless it is terminated or revoked sooner or
renewed.

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(TM) are top-selling Focus Diagnostics products used in laboratories
worldwide. Focus Diagnostics is a wholly owned subsidiary of Quest
Diagnostics.

Focus Diagnostics has collaborated with the U.S. Centers for Disease Control
and Prevention, the World Health Organization and other public health agencies
to help identify and develop diagnostic tests for emerging infectious
diseases. Focus Diagnostics was instrumental in developing the first
laboratory developed test for West Nile virus after it was identified in New
York in 1999. Focus Diagnostics also introduced the first laboratory developed
test for SARS and one of the first FDA-cleared serological test kits for Lyme
disease.

Visit www.focusdx.com for additional information.

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
www.QuestDiagnostics.com.

About 3M
A recognized leader in research and development, 3M produces thousands of
innovative products for dozens of diverse markets. 3M's core strength is
applying its more than 40 distinct technology platforms - often in combination
- to a wide array of customer needs. With $25 billion in sales, 3M employs
75,000 people worldwide and has operations in more than 60 countries. For
more information, visit www.3M.com.

Contacts:
Wendy Bost (Media): 973-520-2800
Kathleen Valentine (Investors): 973-520-2900

SOURCE Quest Diagnostics Incorporated

Media, Wendy Bost, +1-973-520-2800; or Investors, Kathleen Valentine,
+1-973-520-2900, both of Quest Diagnostics