Few things make the Phoenix happier than to see partnerships like the one announced today between particular friends XIFIN and Translational Software. Individually, each company provides exceptional value--not to mention teams of super-smart and just plain Good People. Together, they stand to create a new standard of quality in laboratory reporting, systems management, and billing, with an end-to-end, cloud-based solution.

Genetic testing is a rapidly expanding field and it can be difficult to keep up with new findings, recommendations, and standards. And don't even get us started on the shifting sands of the billing environment!

This new partnership will yield a solution to ensure your laboratory is providing genotype interpretations based on the most current scientific recommendations and that every facet of your business is operating at its absolute best.

Phoenix recommends XIFIN and Translational with no reservations--and they don't pay me to say it!

Disclaimer: Nope, no disclaimer. They really didn't pay me to write this.

The ASCP, CAP, AMP, and ASCO released a new set of recommendations and consensus opinions in April in anticipation of new guidelines for the Evaluation of Molecular Markers for Colorectal Cancer. The panel uses strong, imperative terms to indicate the necessity for thorough mutational analysis of KRAS and NRAS (codons 12, 13 of exon 2; 59, 61 of exon 3; and 117 and 146 of exon 4), plus BRAF V600 and deficient mismatch repair/microsatellite instability (dMMR/MSI) testing.

Here’s the problem—current FDA-cleared or -approved kits (from Roche, Qiagen, Dako, and bioMérieux) do not assess all of these markers and the PMA process is so cumbersome that it is unlikely any manufacturer will be able to produce and obtain approval for a new test in a reasonable time. This leaves laboratories and physicians with a difficult choice: use the necessarily expensive but out-of-date FDA-approved test or use a comprehensive LDT to provide state-of-the art personalized diagnostics? Reimbursement is still a bit of a crap-shoot either way, and the stamp of FDA approval carries some emotional weight even with physicians and in spite of the new NCCN guidelines. However, laboratories and physicians who wish to provide the best possible test for their patients will want to use LDTs that they know will meet the latest standards for clinical sensitivity and specificity.

The laboratory industry has provided a strong, rational response to FDA’s draft guidance on LDT regulation. Molecular testing in oncology and the test case of colorectal cancer provides the foundation for a sound argument against the FDA model of regulating LDTs as devices and for the proposal for modular regulation of LDTs as “In Vitro Clinical Tests” put forth by the Diagnostic Test Working Group.

Reagent kit manufacturers such as TrimGen have developed technology to allow simultaneous detection of all mutations in a given codon. Laboratories can use these reagents to develop their own LDTs, demonstrate their analytical specificity and sensitivity, and quickly provide the depth of analysis required by the latest NCCN guidelines.

As of this year, colon cancer is the second leading cause of cancer-related deaths in the United States. The best way to improve this statistic is to ensure patients receive the best in molecular diagnostics and prognostics, and that they quickly receive the treatment most appropriate to them. The rapid turnaround enabled by forward-thinking reagent manufacturers and laboratorians is the best answer to this need.