SAN DIEGO, CA, February, 14, 2012 | American Clinical Laboratory Association Welcomes Pathway Genomics as New Member
Pathway Genomics, a genetic testing laboratory specializing in genetic testing for nutrition and exercise response, inherited disease, prescription drug response and health condition risks, has received membership in the American Clinical Laboratory Association (ACLA). As the nation’s leading industry group to advocate lab interests with the U.S. Food and Drug Administration (FDA) and Congress, ACLA was created in 1971 and is committed to promoting public awareness about the value of laboratory services in preventing illness, diagnosing disease, and monitoring medical treatment.
“ACLA is proud to welcome Pathway Genomics as its newest member,” said Alan Mertz, president of ACLA. “Pathway Genomics is another example of our nation’s laboratories that are at the forefront of genetic testing and personalized medicine.”
“ACLA is proud to welcome Pathway Genomics as its newest member,” said Alan Mertz, president of ACLA. “Pathway Genomics is another example of our nation’s laboratories that are at the forefront of genetic testing and personalized medicine.”
In addition to Pathway’s ACLA membership, the San Diego-based company was recently accredited by the College of American Pathologists (CAP), and the recipient of a Certificate of Accreditation from the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid, under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
“ACLA is an essential organization within the laboratory community,” said Jim Plante, Pathway’s founder and CEO. “The approval of our membership is representative of the importance of genetic testing, and the promise and value of personalized health care.”
“ACLA is an essential organization within the laboratory community,” said Jim Plante, Pathway’s founder and CEO. “The approval of our membership is representative of the importance of genetic testing, and the promise and value of personalized health care.”
Using saliva samples collected from patients, Pathway provides genetic tests for drug responses, nutrition and exercise response, inherited genetic conditions, and risk of many diseases. Pathway consists of more than 40 scientific and medical professionals, including medical doctors, molecular geneticists, and genetic counselors, as well as an expert scientific advisory board.
SAN DIEGO, CA, September 28, 2011 |Pathway Genomics’ Chief Medical Officer Presents at the 2011 American Dietetic Association Conference
ichael Nova, M.D., Pathway Genomics’ chief medical officer, presented this week at the 2011 American Dietetic Association (ADA) Food and Nutrition Conference and Expo (FNCE). Dr. Nova’s presentation elaborated on the connections between nutrition, lifestyle and genetic expression.
“Ultimately, people need to know genetic makeup and lifestyle have the power to impact health and wellness,” said Nova. “Pathway’s goal is to educate and empower health care practitioners and patients through detailed personal genetic reports and individualized lifestyle recommendations.”
Held at the San Diego Convention Center, the ADA’s annual meeting brought together more than 10,000 registered dietitians, nutrition science researchers, health care providers, industry leaders and policy makers in an effort to address key issues affecting the health of the American people. Tackling the obesity epidemic was a clear highlight of the meeting.
Ultimately, people need to know genetic makeup and lifestyle have the power to impact health and wellness,” said Nova. “Pathway’s goal is to educate and empower health care practitioners and patients through detailed personal genetic reports and individualized lifestyle recommendations.”
Nova’s presentation focused on nutrigenetics – how individual differences in genes influence the body’s response to diet and nutrition – and epigenetics, which focuses on the interaction between genes and environment. Pathway Genomics’ premier personal genetic testing service, Pathway Fit®, is the most comprehensive nutrigenetic testing service on the market. It analyzes over 75 genetic markers and gives patients and their health care practitioners detailed recommendations on exercise, nutrition and lifestyle based on his or her genetic and biometric makeup.
Pathway Fit has been used by thousands of patients for a wide variety of reasons, including weight management, diabetes control, general metabolism function, and eating behavioral insights.
SAN DIEGO, CA, September 28, 2011 |Pathway Genomics Obtains FDA Registration
The U.S. Food and Drug Administration (FDA) has classified and registered Pathway Genomics’ proprietary saliva collection kit as a Class I exempt device. With guidance from licensed health care providers, Pathway’s saliva collection kit is used to collect samples from patients for genetic testing purposes.
“FDA classification and registration is an important step for Pathway to provide physicians and patients with a safe and effective method of providing samples,” said Jim Nickel, M.D., Pathway’s medical laboratory director.
According to FDA regulation, Class I exempt devices must be manufactured under a specific quality assurance program.
“We’re committed to providing patients with medically actionable genetic information,” said Jim Plante, Pathway’s founder and CEO. “We’re also dedicated to doing it in a manner that adheres to regulations set forth by governing agencies.”
“We’re committed to providing patients with medically actionable genetic information,” said Jim Plante, Pathway’s founder and CEO. “We’re also dedicated to doing it in a manner that adheres to regulations set forth by governing agencies.”
In addition to FDA classification and registration of Pathway’s saliva collection kit as a Class I exempt device, Pathway’s laboratory was recently accredited by the College of American Pathologists (CAP), and also received a Certificate of Accreditation under the Clinical Laboratory Amendments (CLIA) of 1988.
SAN DIEGO, CA, September 22, 2011 |Pathway Genomics Receives CLIA Certificate of Accreditation
Pathway Genomics, a genetic testing laboratory specializing in screening for nutrition and exercise response, inherited disease, prescription drug response and chronic health condition risks, announced that it has received a Certificate of Accreditation from the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid, under the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
“CLIA accreditation demonstrates Pathway’s commitment to exceptionally high standards of laboratory testing,” said David Becker, Ph.D., Pathway’s chief scientific officer. “Reaching this level of accreditation is an important milestone in the company’s growth.”
The objective of CLIA regulations is to ensure quality laboratory testing. While there are several levels of CLIA certification, a Certificate of Accreditation requires the laboratory and its staff to perform at the highest levels of quality.
“CLIA accreditation demonstrates Pathway’s commitment to exceptionally high standards of laboratory testing,” said David Becker, Ph.D., Pathway’s chief scientific officer.
Last month, Pathway’s laboratory was also accredited by the College of American Pathologists (CAP). Both the CLIA and CAP accreditations signify the company’s dedication to excellence, and help the company bring medically actionable genetic information to physicians and their patients.
SAN DIEGO, CA, August 22, 2011 | Pathway Genomics and BIOCOM Host Roundtable with Chief Deputy Whip, Congressman Peter Roskam
From left: Pathway CEO Jim Plante and Chief Deputy Whip, Congressman Peter Roskam (R-IL)
In a sign of Congress’ growing recognition of the importance of San Diego’s world-leading biotech community, Congressman Peter Roskam (R-IL), Chief Deputy Whip and fourth ranking Republican of the House of Representatives, toured Pathway Genomics and visited with leaders of San Diego’s biotech community.
“I was very impressed. San Diego’s biotech community is indeed leading the world. Every day it becomes more and more important to our nation’s economy and balance of trade,” said Roskam. “It’s critical that Congress works with the private sector to enact policies that support and encourage this kind of revolutionary innovation, and protect public safety.”
The event was held last week at Pathway’s corporate headquarters in San Diego and included a tour of its state-of-the-art laboratory, which is certified by the federal government, licensed by the state of California, and was recently accredited by the respected College of American Pathologists (CAP).
“It’s critical that Congress works with the private sector to enact policies that support and encourage this kind of revolutionary innovation, and protect public safety,” said Congressman Roskam.
“Maintaining an open dialogue between lawmakers and members of the biotech community is vital to the growth of the industry,” said Jim Plante, founder and CEO of Pathway Genomics. “Congressman Roskam clearly recognizes the vast potential the field of genetics has to improve lives, and personalize the delivery of healthcare.”
Roskam’s visit follows a trip by Plante to Washington, D.C., where he met with the Speaker of the House John Boehner, House Majority Leader Eric Cantor, and Congressman Roskam to talk about what the biotech industry needs from Congress. Roskam’s trip to Pathway demonstrates the leadership’s efforts to help the job creators in our society.
From left: BIOCOM CEO Joe Panetta and Congressman Roskam
“We have unlimited potential here, both for the economy and to improve the quality of life in America,” said Joe Panetta, president and CEO of BIOCOM. “By working together, the United States is well-positioned to solidify its position as the worldwide leader in this fast-growing economic sector, and create tens of thousands of high-wage ‘green’ jobs.”
Congressman Roskam’s visit to Pathway comes at an exciting and developing time for the field of genetic testing, and it illustrates the company’s commitment to promote collaboration between industry leaders and the federal government. Pathway plans to continue active involvement with U.S. politicians to help build a road to success for the country’s job growth, innovation, and rapidly growing field of personalized health care.
SAN DIEGO, August 8, 2011 | Pathway Genomics Earns Accreditation from College of American Pathologists
Pathway Genomics has received laboratory accreditation from the College of American Pathologists (CAP). With CAP accreditation, Pathway joins an elite group of clinical laboratories around the world that have met exceptionally rigorous standards in order to achieve the highest caliber of quality.
Pathway consists of more than 40 scientific and medical professionals, including medical doctors, scientists, and genetic counselors, as well as an expert scientific advisory board. The company provides genetic tests for drug responses, nutrition and exercise, inherited genetic conditions, and chronic diseases. Pathway’s high-complexity genetic testing laboratory provides its services to patients and corporations through health care practitioners. Pathway also has numerous alliances with large Fortune 500 companies. CAP accreditation serves to further substantiate the accuracy and reliability of the company’s analytical testing procedures in a rapidly growing industry.
WASHINGTON, D.C., March 18, 2011 | Speaker of the House John Boehner and Top Congressional Leaders Discuss the Impact of Federal Regulations on Job Creation
From left: Pathway CEO Jim Plante and House Speaker John Boehner
Pathway Genomics CEO Jim Plante was among the members of a small group of American entrepreneurs and CEOs invited to the United States Capitol this week to participate in a round table discussion with top Congressional leaders about federal regulations and their impact on job growth and the economy. The event, held before a large audience and broadcast live, was part of a continuing effort by the leadership to engage in an ongoing dialogue with innovative job creators in the private sector to find ways to work together to reduce government red tape, help create jobs and boost the economy.
“We probably ought to take a real serious look at how regulators regulate. We have the most adversarial regulatory system in the United States than almost anywhere in the world,” said House Speaker John Boehner. “All of my colleagues are having this event today so that we can better understand the obstacles that are in the way of creating jobs in America.”
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