LungLife AI, INC LungLife AI Laboratory achieves CAP accreditation (8967S)
November 19 2021 - 2:00AM
UK Regulatory
TIDMLLAI
RNS Number : 8967S
LungLife AI, INC
19 November 2021
LungLife AI, Inc.
(the "Company" or "LungLife")
LungLife AI Clinical Laboratory achieves CAP accreditation
Independent inspection confirms highest standard of care for
laboratory patients
LungLife AI (AIM: LLAI), a developer of clinical diagnostic
solutions for lung cancer enhanced by artificial intelligence,
announces that its clinical laboratory in Thousand Oaks, California
has been awarded accreditation by the College of American
Pathologists (CAP). The Company, whose clinical laboratory is
already CLIA certified, voluntarily sought the accreditation as
part of its on-going commitment to maintaining best in class
quality systems.
The Company's laboratory processes have been independently
assessed by the CAP, the world's largest organisation of
board-certified pathologists and leading provider of laboratory
accreditation and proficiency testing programmes, during a recent
on-site inspection designed to ensure the highest standard of care
for all laboratory patients.
As part of this process, the inspectors examine a laboratory's
records and quality control procedures, as well as laboratory staff
qualifications, equipment, facilities, safety programme and overall
management. The U.S. federal government recognises the CAP
Laboratory Accreditation Program as being equal-to or
more-stringent than the government's own inspection programme, and
the Centers for Medicare and Medicaid Services (CMS) have granted
the CAP Laboratory Accreditation Program "deeming authority," which
allows for CAP accreditation in lieu of a CMS inspection.
Lara Baden, VP Clinical Operations, LungLife AI, commented: "We
are proud of the recognition of our quality by the College of
American Pathologists through receiving this accreditation, which
reflects our commitment to maintaining the highest standards of
excellence in laboratory testing for patients and ensuring that our
work practices meet the rigorous CAP assessment standards. This
accreditation will provide ordering physicians and patients a
further degree of confidence in the results they are receiving for
our LungLB(R) test as well as for future products."
For further information please contact:
LungLife AI, Inc. www.lunglifeai.com
Paul Pagano, CEO Via Walbrook PR
David Anderson, CFO
Investec Bank plc (Nominated Adviser Tel: +44 (0)20 7597 5970
& Broker)
Daniel Adams / Virginia Bull / Cameron
MacRitchie
Walbrook PR Limited Tel: +44 (0)20 7933 8780 or LungLifeAI@walbrookpr.com
Paul McManus / Alice Woodings Mob: 07980 541 893 / 07407 804 654
About LungLife
LungLife is a developer of clinical diagnostic solutions for
lung cancer enhanced by artificial intelligence. The Company's
diagnostic solutions are designed to make a significant impact in
the early detection of lung cancer.
The Company's technology is a combination of the recovery of
rare cells and blood-based biomarkers shown to be altered in lung
cancer. The Company employs machine learning to improve biomarker
detection, and intends to build a deep, novel pool of lung
cancer-related data for AI-enabled applications designed to improve
its diagnostic solutions over time.
The Company's core technologies are integrated in the LungLB(R)
test, which is intended to be used as a tool to provide physicians
with additional information to help in the decision-making process
for people with indeterminate lung nodules that may be lung cancer
following a CT scan. There are estimated to be over 1.5 million
individuals with indeterminate lung nodules diagnosed each year in
the United States. The LungLB(R) test may have additional
utilities, the most significant of which is likely to be in
monitoring individuals for recurrence following surgical removal of
cancerous lung nodules.
The Company has completed a 149 subject pilot study to evaluate
the LungLB(R) test, which showed a well-balanced performance and a
Positive Predictive Value of 89 per cent. The Company is now
gearing up to proceed to a larger, multi-centre validation study to
garner regulatory and reimbursement support and facilitate
commercialisation.
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