Cartagenia, leader in providing clinical genetics and pathology labs with variant assessment & reporting support software, announced a partnership with Lexington, Massachusetts-based N-of-One, an industry leading provider of patient-specific clinical interpretation for molecular profiles at the disease, gene and variant level.

With the availability of N-of-One’s services from within the Bench Lab NGS software platform, pathology genetics laboratories can now integrate N-of-One clinical interpretation based on genomic profiling and tumour information into their somatic variant analysis and reporting workflow.

N-of-One clinical interpretation saves pathologists and physicians hours of research and preparation time per patient, without sacrificing quality. N-of-One clinical interpretation delivers scientific and clinical evidence that supports possible therapeutic strategies relevant to each specific patient case. N-of-One clinical interpretation can be configured to easily and efficiently integrate into an organization’s reporting needs.

The N-of-One clinical interpretation services are complimentary to the capabilities we provide with the Bench Lab NGS platform, noted Steven Van Vooren, scientific co-founder of Cartagenia. “No tumor is exactly the same – and N-of-One has a team of experts that provides exactly those deep and patientspecific insights our pathology lab customers need,” Van Vooren said. “Labs automate their somatic variant assessment SOPs on our software platform to Cartagenia identify variants that are relevant to further review, and now can look to N-of-One to provide tailored, patient-specific insights that will efficiently support the pathologists in providing physisicans with the relevant information regarding drugs, trials and treatment options. Labs can include configurable N-of-One clinical interpretation in their lab reports in a single, controlled and supervised workflow”.

To enable this partnership, Cartagenia has created the infrastructure necessary to integrate a lab’s internal knowledge with external information, such as publicly available databases, data shared between collaborating labs, and partner services. Labs can now bring together their proprietary expert knowledge – from their own curation efforts, literature review, and previous findings from other samples – with up-to-date, tailored content on treatment options.

Herman Verrelst, Cartagenia’s CEO, states: “NGS is rapidly being adopted as a standard test in pathology labs. Our customers derive great value from complementing their internal knowledge bases with up-to-date, high-quality interpretation and insights that help physicians assess treatment options. We are very excited to work with N-of-One as their team of in-house PhD and MD experts deliver industry-leading, clinical and scientific evidence tailored to each cancer patient’s molecular profile.”

“Cartagenia serves a broad customer base of leading clinical genetics and pathology laboratories that value an efficient diagnostic workflow.” said Chris Cournoyer, CEO of N-of-One. “We are excited to partner with Cartagenia. The integration of our Clinical Interpretation services into Cartagenia’s clinical-grade software platform for variant assessment support will allow clinical laboratories to keep up with the scale and pace of change in knowledge, and support their physicians in patient treatment planning”.

N-of-One and Cartagenia will promote the partnership by cooperating on marketing initiatives to inform customers of the benefits and advantages of the joint use of each company’s solutions. Cartagenia will be showcasing the availability of N-of-One’s clinical interpretation services through the Bench Lab NGS software platform at the upcoming American College of Medical Genetics annual clinical meeting (ACMG 2015) on March 25-27 at the Salt Palace Convention Center in Salt Lake City, Utah.

Cartagenia supplies variant assessment support and lab report automation software, database systems, and related services to genetic labs, pathology labs and clinicians, enabling them to perform clinically relevant genetic analyses quickly and efficiently, and offer patients and carers high-quality genetic interpretation and counselling.

Cartagenia Bench Lab allows automation of variant assessment protocols and lab report generation for structural and molecular variant assays such as Arrays, Sanger and Next Generation Sequencing. It supports communication with referring physicians, allows labs and clinicians to put variants in their clinical context, and supports confident data sharing.

The Cartagenia Bench platform is built in collaboration with genetics labs and clinical experts involved in routinemedical practice. Because of this, Bench Lab addresses the specific needs of genetic diagnostic labs and clinicians.

Cartagenia Bench is built using a certified ISO13485 Quality Management System and is registered with the FDA as an exempt  Class I Medical Device in the United States and as a Class I Medical Device in Europe in conformity with the essential requirements and provisions of the Council Directive 93/42/EEC concerning medical devices, and with the relevant harmonized standards EN ISO62304.

N-of-One, a leader in enabling precision medicine for oncology, leverages its world-class team of experts coupled with a highly proprietary platform that allows us to provide clinical solutions and services, such as molecular interpretation, to clinicians at the point of care.