Download ambry genetics managed care value

managed care value / april 2014
ambry genetics
Ambry Genetics (Tax ID 33-0892453 & NPI 1861568784) is a molecular diagnostic laboratory located in Aliso Viejo, CA that
applies innovative technology to answer complex questions in the diagnosis of genetic conditions and hereditary risk.
managed care value
Ambry Genetics is your managed care partner. Our goal is to provide health care providers cost-effective, clinically-relevant testing
solutions for the patients they serve. The following are some of the reasons we are contracted nationally with many of the leading
Health Insurance Plans:
comprehensive menu:
unparalleled service and support:
Over 300 different genetic tests including the most commonly
ordered assays (BRCA1/2, Lynch Syndrome & CFTR testing for
cystic fibrosis).
Genetic testing can be complex; we provide pre- and post-test
support from 30+ in-house genetic counselors to clinicians so
they can better serve their patients.
advocates of responsible testing:
ongoing education:
Ambry markets primarily to genetics-trained professionals and
our laboratory genetic counselors review every test order for
medical necessity.
options:
Gene testing can be ordered sequentially (most common gene
first followed by next most common), concurrently for STAT
purposes, or as part of a comprehensive multi-gene test that
accounts for multiple differentials.
Ambry conducts routine webinars in an effort to educate health
care providers on the benefits and clinical utility of genetic
testing. We will also in-service clinics with our field-based
genetic counselor team.
research to improve patient care:
Ambry is committed to sharing data and promoting scientific
discoveries through presentations at national meetings and peerreviewed publications.
testing services overview
With over 300 genetic tests available, Ambry Genetics offers a full menu of diagnostic solutions for multiple medical specialties
including geneticists, oncologists, and neurologists. Our current specialty menus include over 35 individual cancer genes (largest
available in the US), multiple neurology genetic tests, and a large pediatric genetic tests menu.
neurology
cancer
test menu highlights
test name
test description
BRCA1 & BRCA2
Comprehensive testing including gene sequence and deletion/duplication
(i.e. large rearrangement), Ashkenazi Jewish panel, and specific site analyses
BRCAplus
Multi-gene test of 6 genes associated with hereditary breast cancer, all with published clinical
management guidelines
GYNplus
Multi-gene test of 9 genes associated with hereditary ovarian and hereditary uterine cancer, all
with published clinical management guidelines
BreastNext
Multi-gene test of 18 genes associated with hereditary breast cancer
OvaNext
Multi-gene test of 23 genes associated with hereditary ovarian, uterine and breast cancer
PancNext
Multi-gene test of 13 genes associated with hereditary pancreatic cancer
ColoNext
Multi-gene test of 14 genes associated with hereditary colon cancer and polyposis
RenalNext
Multi-gene test of 18 genes associated with hereditary renal cancers
PGLNext
Multi-gene test of 10 genes associated with hereditary paragangliomas and pheochromocytomas
CancerNext
Multi-gene test of 28 genes associated with hereditary cancers
Lynch syndrome
Comprehensive testing for MLH1, MSH2, MSH6, EPCAM, and PMS2
Polypsosis testing
Comprehensive menu of polyposis genes: APC, MYH, STK11, SMAD4, BMPR1A, & more
FMR1
Comprehensive testing for Fragile X Syndrome
Cytogenetic
Karyotype analyses
Microarrays
Analyses for micro-deletions/duplications (SNP+CGHarray, 180K Oligo Array)
XLID Panel
Multi-gene test of 81 genes associated with X-Linked Intellectual Disability
Noonan syndrome
Multiple testing options for PTPN11, SOS1, RAF1, and KRAS
Rett syndrome
Multiple testing options for MECP2, CDK5L, and FOXG1
Exome
Clinical Diagnostic Exome testing with 8-12 week turn-around-time
benefits of multi-gene cancer tests using next-gen sequencing: summary of experience
We have offered hereditary cancer single gene/syndrome testing since 2003 and in early 2012 we were the first commercial laboratory to offer large multi-gene cancer tests. The uptake of testing for all large multi-gene cancer tests has been strong since we
launched two years ago. In the first year we received over 2500 orders for multi-gene cancer tests from institutions such as: Dana
Farber Cancer Center in Boston, USC Norris Cancer Center in LA, City of Hope Cancer Center, UCLA, UCSF, Cedars Sinai in Los
Angeles, Fox Chase Cancer Center in Philadelphia, Cleveland Clinic, Mayo Clinic, Yale Cancer Center, and hundreds of other cancer
centers around the country. Order volume has grown exponentially in the last year.
We have reported well over 15,000 multi-gene cancer test results and have very significant data showing the yield of testing using
this approach. Among the first 1000 tests that were reported (second-line testing in patients who previously tested negative for
BRCA1/2) there was a positive result that impacted medical management in 10.6%. This is slightly higher than the 10% positive rate
for BRCA testing alone (reported by Informed DNA for their patients who met criteria and underwent testing.) Therefore, the utilization of multi-gene cancer tests that include BRCA1/2 (when applicable) in addition to the other associated genes will essentially
double the rate of identifying high risk individuals for whom changes in surveillance and screening will provide the greatest benefit.
sample types accepted
• Blood
• Saliva
• DNA
• Blood Spots
common cpt/mopath codes billed by ambry genetics
81211
81213
81223 81922
81321 81404
81292
81405
81295
81406
81298
81407
client base in usa
For 13 years Ambry Genetics has been serving the molecular diagnostic testing needs of hospitals, reference labs, and specialty
clinicians in North America. Our client base includes the following medical centers and care givers:
clinical expertise
scientific and clinical expertise
Ambry Genetics is committed to providing clinicians and patients with world-class genetic testing services. We have a dedicated
team of scientists who have spearheaded the development and application of new genetic technologies for the advancement of
diagnosis and disease research. Our highly experienced clinical team of Medical Geneticists, Board-Certified Medical Directors and
over thirty Board-Certified Genetic Counselors works together to help clinicians provide appropriate testing and accurate results
interpretation for each patient. We are a trusted resource for clinicians, as we are CAP-accredited, CLIA-licensed and have our own
in-house medical technologist training program.
Our Clinical Leadership include the following nationally recognized physicians and pathologists:
Elizabeth Chao, MD, FACMG
Chief Medical Officer
Trieu Timothy D. Vo, PhD, DABMG, FACMG
Laboratory Director
Sharon Mexal, PhD
Director of Clinical Operations
Sha Tang, PhD, DABMG
Assistant Director of Clinical Genomics
Aaron Elliott, PhD
Director of Research and Development
Chia-Ling Gau, PhD, DABMG
Laboratory Director
customer service
Ambry’s Clinical and Client Services Teams are available to assist providers and patients throughout the entire testing process,
including:
• Order processing
• Benefit eligibility and verification
• Prior authorization
• Reimbursement questions
• Understanding test result reports
• On-line test ordering, status tracking and patient reporting with AmbryPort 2.0/Laboratory Bi-Directional Interfacing
Ambry’s Medical Directors and Genetic Counselors are available to provide clinicians with information and support Monday
thru Friday from 8:00 AM EST to 8:00 PM EST. Ambry also has dedicated Preverification and Authorization teams that are
available to assist providers and patients with benefit eligibility verification, test authorization and questions regarding billing and
reimbursement. Our goal is to make the genetic testing process simple and easy from ordering to result reporting and we are always
available along the entire pathway to answer any questions.
about ambry
Founded in 1999 by CEO Charles Dunlop, Ambry Genetics has consistently been at the forefront of applying new technologies
to the clinical molecular diagnostics market place. Known initially for being the first commercial laboratory to offer complete
sequence analysis of the Cystic Fibrosis gene, Ambry Genetics has expanded its services to be recognized as a global leader in
providing cutting-edge, comprehensive, accurate genetic testing services. Our Clinical Diagnostics and Genomic Services divisions
are focused on meeting the needs of healthcare providers and researchers in university, community, pharmaceutical, and biotech
settings. Ambry’s solid reputation begins with being known as “gene sequencing experts” and ends with unparalleled customer
service.
Over the years, Ambry Genetics has spearheaded the development and application of new genetic technologies for the
advancement of diagnosis and disease research. Our Genomic Services division’s access to new technology and early adopter
programs with all of the major sequencing manufacturers has allowed Ambry to work with new testing systems years before they
are applied to the clinical market place. Some of our first to market launches include:
• First to offer CTFR gene sequencing commercially for Cystic Fibrosis
• First to offer NextGen/Massively Parallel Sequencing XLID multi-gene test (81 genes)
• First to offer Whole Exome Sequencing clinically
• First to offer NextGen cancer multi-gene tests
• First to offer BRCA1&2 testing post June 13, 2013 Supreme Court Ruling on gene patents
Providing outstanding service and support are top priority at Ambry Genetics. We strive to keep the test ordering process easy by:
validating our tests in multiple sample types, including saliva, so that blood draw does not become a logistic issue; preverification of
insurance benefits performed within 72 hours so the patient knows out of pocket costs before start of testing; and available pre- and
post-test consultation with an Ambry clinical expert to assist caregivers in the diagnosis and treatment of their patients for the best
possible clinical outcome.
for more information, please contact:
Direct 949.900.5500
Fax 949.900.5501
[email protected]
D0414-09-188-MKG-00