Assay Development

Kashi Clinical Laboratories offers high-quality assay development for a wide variety of platforms and chemistries that support multiple specimen types. Our experienced research and development team develops all testing in-house, upon request, and it is tailored to your needs.

As a healthcare provider, is there a genetic test you would like to use in your practice, but that isn’t yet available on the market, or is cost-prohibitive? Contact Kashi to find out more about collaborations in testing development.

Assay Validation

We combine rigorous analytical validation with the flexibility to customize assay parameters and reporting to best meet your needs. Custom assay designs are critical to providing accurate, sensitive, reproducible, efficient, and standardized molecular testing. At Kashi, our accomplished team applies rigorous scientific methods for rapid assay development and validation to not only meet, but exceed, current regulatory guidelines set by Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists.

The Kashi team uses a variety of molecular approaches tailored to your unique needs, including  exome and custom targeted sequencing by Next Generation Sequencing and Sanger Sequencing, RT-PCR for gene expression and SNP genotyping, and capillary electrophoresis. Our commitment to quality biomarker detection extends throughout Kashi. We use the latest in technology, and our customer service is personal and timely.

Case Study: Autism Research Gene Panel Development Process

Hatha Gbedawo, N.D., is a Seattle-based naturopathic physician with a private practice specialized in pediatrics. Her clinical interests include childhood neurodevelopment and behavior disorders, including autism and autism spectrum disorders. Dr. Gbedawo believes that healing the whole family provides the best environment for healthy children and, to that end, she began researching autism and the genetic variations likely contributing to the disorder. Believing that the genes for BH4 and GAD1 are likely culprits in patients with autism, Dr. Gbedawo hoped to find a CLIA (Clinical Laboratory Improvement Amendments) certified laboratory to test for mutations. Her goal was to develop a scientifically rigorous BH4 SNP (single nucleotide polymorphisms) panel associated with autism that would give her useful clinical information, including decreased function versus frank mutation, and an appropriate GAD1 panel for seizures and anxiety.

Dr. Gbedawo had heard about Kashi Health from a colleague and called the founder, Dr. Zahra Kashi, for guidance. “I found labs that could test for genetic mutations in DHPR, but they weren’t focused on functional mutations,” said Dr. Gbedawo. “I am looking for a particular genetic marker with indications for slowing down or speeding up the enzyme or whether it changes the enzyme function to a larger pathological degree. Testing for mutations to gather information about the enzyme function in these genes may help me provide better treatment plans for my patients. For instance, if I know that the BH4 SNP is slowing enzyme function I may recommend a particular supplement or nutritional plan.”

Dr. Kashi and her team quickly gathered for a phone conference to hear about Dr. Gbedawo’s genetic testing inquiry. Out of the conversation came achievable goals for Dr. Gbedawo’s testing needs and a personalized plan for collaboration. “After talking with the Kashi researchers, I felt excited about what we could figure out and do together,” said Dr. Gbedawo.

In collaboration with Dr. Gbedawo, the Kashi team scrutinized the peer-reviewed journal articles on BH4 SNPs. Then the researchers developed a comprehensive and affordable three-tiered panel of testing, focusing on the most relevant genetic markers for what Dr. Gbedawo hoped to accomplish for her patients.

Dr. Gbedawo was pleased with the strategy for her unique testing needs and gave the go-ahead for implementation. She received her first lab report from Kashi on the panel within five business days.

“I was so excited when I got my patient’s first genetic test report,” said Dr. Gbedawo. “Kashi did a great job of outlining the problem and preparing the results. It was very redeeming as a healthcare provider to see the outcome of all our hard work,” she said. “I am looking forward to my next genetic testing project with Kashi.”

Contact us at 877-879-1815 or 503-206-4989, or use our Contact Form to learn more about testing development.