MannKind Receives Accreditation From College Of American Pathologists

Published: Jun 29, 2017

SALT LAKE CITY, June 29, 2017 (GLOBE NEWSWIRE) -- Sera Prognostics, Inc., a women’s healthcare company, announced today that the Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to Sera Prognostics, Inc., based on results of a recent on-site inspection as part of the CAP’s Accreditation Programs.

The facility’s director, Todd Randolph, M.D., medical director of Sera Prognostics, was advised of this national recognition and congratulated for the excellence of the services being provided. Sera Prognostics is one of more than 8,000 CAP-accredited facilities worldwide.

“Sera’s science and laboratory operations capability is of the highest quality, and the CAP certification is a tribute to our company and strong team of laboratory professionals,” stated Randolph.

“Achieving CAP accreditation is a key milestone for Sera Prognostics as we work to realize our company’s vision to improve the well-being of mothers and infants,” stated Greg C. Critchfield, M.D., M.S., chairman and chief executive officer of Sera Prognostics. “This achievement is recognition of the excellent work performed by our laboratory operations team and quality/regulatory department to provide pivotal information to doctors and patients. I salute all of our dedicated employees and advisors who join us in this quest.”

The U.S. federal government recognizes the CAP Laboratory Accreditation Program, begun in the early 1960s, as being equal-to or more-stringent-than the government’s own inspection program.

During the CAP accreditation process, designed to ensure the highest standard of care for all laboratory patients, inspectors examine the laboratory’s records and quality control of procedures for the preceding two years. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety program and record, and overall management.

“Sera Prognostics demonstrates leadership, innovation, and a passionate commitment to standards of excellence while providing the highest quality services, ultimately for patients,” said Bharati Jhaveri, MD, FCAP, chair of the CAP’s Council on Accreditation. “The CAP congratulates Sera Prognostics on its recent CAP Accreditation.”

About the College of American Pathologists

As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, read the CAP Annual Report at cap.org.

About Preterm Birth

According to the March of Dimes, globally preterm birth affects 15 million infants each year, with 1 million deaths occurring from prematurity. Of nearly 4 million babies born annually in the U.S., approximately one in ten is born prematurely. Preterm birth is defined as any birth before 37 weeks gestation, and is the leading cause of illness and death in newborns. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the lives of affected children.

About the PreTRM® Test

The PreTRM® test is the first and only broadly clinically-validated blood test that provides an early and individual risk prediction for spontaneous preterm birth in asymptomatic, singleton pregnancies. The PreTRM test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM test can help physicians identify early in the pregnancy (as early as 19 weeks of gestation) which women are at increased risk for premature delivery, enabling more informed clinical decisions based on each woman’s individual risk. The PreTRM test enables researchers to better understand the causes of preterm birth and to develop new therapies to improve newborn health.

The PreTRM test is ordered by a medical professional. For more information about the PreTRM test, please visit www.PreTRM.com and the PreTRM test YouTube Channel. You can also join the conversation on Facebook and @PreTRM.

About Sera Prognostics, Inc.

Sera Prognostics, a women’s health company, develops innovative diagnostic tests focused on the early prediction of preterm birth (PTB) risk and other complications of pregnancy. Sera has launched its PreTRM® test, the first and only broadly clinically-validated blood test to accurately predict early in pregnancy the risk of premature birth. The test objectively reports to the physician the risk of premature delivery, enabling earlier proactive interventions designed to prolong gestation and improve neonatal health outcomes. Sera’s technology addresses both the health and economic challenges of PTB. The Company’s strong management team has significant clinical development and women's healthcare diagnostic experience. Sera is backed by highly respected healthcare investors, including Domain Associates, InterWest Partners, Catalyst Health Ventures, the Bill & Melinda Gates Foundation, and LabCorp, who recently entered into an agreement with the Company to become the exclusive U.S. distributor of the PreTRM test. Currently, Sera is working with the Gates Foundation to translate the Company’s discoveries into technologies well suited for low-income countries in its journey to improve maternal and infant health globally. Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company's website at www.seraprognostics.com.

Company Contact: Andrew Sauter, CFO Sera Prognostics, Inc. info@seraprognostics.com (801) 990-0772 Media Contact for Sera Prognostics: Terri Clevenger Continuum Health Communications tclevenger@continuumhealthcom.com (203) 856-4326

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