About Us

Welcome to Qni Diagnostics

We are an ethical company focused not only on the welfare of our customers but of our team. (GP)

About

We are an ethical company focused not only on the welfare of our customers but of our team.
QNI Diagnostics is team focused and prides itself in an egoless environment where the best ideas flourish.
What we focus more on are product deliverables, team and culture fit equally in order for us to accomplish our mission.

Mission

QNI Diagnostics is focused on developing innovative In Vitro Diagnostic (IVD) devices with integrated technology at the Point-of-Use connecting the patient consumer with their health care practitioner to allow for real time diagnosis of disease stage.
We believe in empowering the patient customer by changing the diagnostic paradigm to chart the future of their healthcare with real time, at home and with clinical accurate diagnostic testing.

What We Do

We are an innovation driven venture with an IP portfolio strategy based on personalized medicine which is constantly ideating disruptive solutions by developing and commercializing rapid at home tests.
We focus on aggressively developing more products to compete in the market of molecular diagnostics for immunoassays, single nucleotide detection, novel automated sample prep platforms, reagents, biomarker discovery.

Team Members

Dr. Gerson Aguirre

CEO

CEO: Dr Gerson Aguirre is a co-founder of QNI Diagnostics with10 years of experience in managing and developing R&D technologies for POC and molecular diagnostic products. Founder of Q&I, LLC consulting firm, providing development and commercialization solutions for IVD products. Director of Microfluidics Zepto Life Technologies developed molecular test products for hand-held device. Lead Mech Eng Stratos Genomics, recent acquisition by Roche. Holds 7 patents in POC tech.

Dr. Chandra Dixit

CSO

CSO: Dr Chandra Dixit is a co-founder of QNI Diagnostics and leads projects for the development of rapid molecular tests. Previously spent 15 years developing tools and methods for bioanalytical and IVD applications at GLP/cGMP with over 5 years in IVD genetic and immunoassay manufacturing. He has transferred 6 products from development to manufacturing as senior scientist in PBL Assay Science and QIAGEN which was acquired by Thermo Fisher. Currently holds 3 patents in IVD. He is the author of over 40 high impact journal articles along with books and chapters in the IVD technology space.

James Meyer

Business Advisor

Business Advisor: An accomplished and seasoned executive with over 37 years of experience in Pharmaceutical Industry with heavy emphasis in Oncology and Immunology. As US General Manger Clinigen Group, Commercial Medicines he is building and leading first commercial business operation including acquisition and transition of four oncology products. President of JPM Pharma Commercial Development LLC, specializing in the commercial development of oncology-based biopharmaceutical products. Senior Vice President of Commercial Operations at TenX Biopharma Inc. responsible for overseeing the worldwide commercial development of Zanolimumbab.

Our 6-D Process

01.

The Preanalytic Testing Phase

The pre-analytic testing phase occurs first in the laboratory process. This phase may include specimen handling issues that occur even prior to the time the specimen is received in the laboratory. Important errors can occur during the pre-analytic phase with specimen handling and identification.

02.

Test Information to Provide to Users of Laboratory Services

It is the responsibility of the laboratory director to ensure that the customers’ needs are met … appropriate, providing needed information, and being courteous. Organization … When laboratory testing is being performed to meet a public health need, public … complete but user friendly, and a timely delivery system.

03.

Test Selection Criteria

In other words, testing and selection has to be achievable. Every test needs to satisfy all four criteria (objectivity, validity, reliability, and economy) in order to select the best rowers.

04.

Test Performance

The goal of our study was not to recommend an ‘absolute best’ or ranked list of rapid serology antibody tests, but rather to provide well-controlled performance data to highlight a number of high-quality assays to inform the medical community and government organizations.

05.

Specimen Submission

Our laboratory has noticed an increase in the number of specimens that are submitted to our laboratory that are mislabeled, lacking patient identifiers, and/or unlabeled.

Our goal is to adhere to Joint Commission (JC) and the requirements set forth in the #1 Hospital National Patient Safety Goal (NPSG.01.01.01): Identify Patients Correctly.

06.

Specimen Referral

Strengthening specimen referral networks is critical to serve the entire healthcare delivery system and establish preparedness strategies for effective disease control and prevention,” they said. This coordinated approach involves the safe transfer of a patient specimen from a resource-scare lab or health facility to a facility with the capability to conduct the needed test(s) and provide timely, reliable results.