Invitae is committed to offering gene panels that are high quality, flexible, customizable, inexpensive, and—importantly—responsive to clinicians’ specific diagnostic questions or indications. From the beginning, we designed our laboratory processes to be extremely efficient, which allowed us to test large numbers of genes at a low price. With the recent massive expansion of our catalog this spring, we’ve seen a small uptick in the number of clinicians asking to place a single order that crosses between clinical areas—oncology and cardiology, for example.
Our model has always been to offer any number of genes within a single area of medicine for the same price. With the larger test catalog and more tests being ordered, the time is right to provide additional clarity to our pricing structure by more clearly apportioning genes into “clinical areas.” To continue to qualify as a single order with a single requisition, a single sample, and a single charge, custom orders can include only genes from a single clinical area. (Please view our online test catalog to see the clinical areas.) Orders that include genes in two different clinical areas will require two sample tubes and will result in two reports generated by two different teams of clinical experts. Please be aware that your order will also represent two billable events, one for each clinical area.
This approach allows us to keep our costs down so that we can translate these savings into the lowest possible prices for patients. It’s also analogous to what is done in the rest of clinical laboratory testing, where a diagnostic question in one disease area, such as chemistry (electrolytes, liver function, or renal function), might be addressed by a comprehensive metabolic panel (CMP) while a different diagnostic question about red cells, white cells, or platelets would require a complete blood count (CBC). The CMP and CBC are separate tests, performed on different blood samples using different assays, and billed separately.
We have made every effort to use good clinical judgment when deciding which genes to assign to which clinical area. In addition, a good number of genes have been assigned to more than one area when variants in those genes are relevant to more than one area. For example, many genes including Alpha-1,4-glucosidase (GAA) are included in both the neuromuscular disorders clinical area and the metabolic and newborn screening confirmation clinical area.
Based on ordering history, we do not expect this policy to affect the great majority of our customers; nearly all test requisitions we receive fall into a single clinical area. We recognize, however, that it is possible for a single diagnostic question to require a panel that includes genes apportioned to different clinical areas. We encourage clinicians who encounter such a circumstance to contact us; we intend to constantly improve our clinical area definitions and boundaries and believe that client feedback will be key to this process.
The medical staff here at Invitae firmly believe that with this reconfiguration we can continue to offer the same high quality testing at low prices, across an ever-expanding number of genes. We’re constantly working to improve our model and services, and encourage you to share your feedback with us by contacting Client Services.