IHC - PD-L1
SP142- Notice of Roche Urgent Medical Device Correction
On November 21, 2022, NeoGenomics
received an Urgent Medical Device Correction notice from Roche pertaining to
specific lot numbers of the Ventana PD-L1 (SP142) assay resulting in
unacceptable light staining requiring review of any negative results. At this time there is
no action needed from our clients.
We appreciate your patience as we work towards a resolution. Should you have
any questions or need any assistance, please do not hesitate to contact your
local NeoGenomics Sales Consultant or our Client Services team at (866)
776-5907, option 3.
Now Available -
FOLR1 Sponsored Testing Program
Folate Receptor alpha (FRα) protein expression in patients
with platinum-resistant ovarian cancer is now actionable. NeoGenomics is
pleased to partner with ImmunoGen on a FOLR1 sponsored testing program
initiative called FR-ASSIST™, providing access to the newly FDA-approved FOLR1
Immunohistochemistry companion diagnostic (CDx) test for ovarian cancer
(including epithelial ovarian cancer, fallopian tube or primary peritoneal
cancer) at no cost to eligible patients.
Details: The FOLR1 Sponsored Testing Program includes one (1)
FOLR1 FDA (ELAHERE™) for Ovarian Carcinoma test per patient.
Please use the FOLR1 Sponsored Testing Program Requisition to participate in
To learn more about the program, eligibility criteria and to download the test
requisition form, visit the FOLR1
Sponsored Testing Program webpage.
t(3;8) by FISH is now available!
- BCL6/MYC translocation is observed
recurrently in high-grade B-cell lymphoma, reported in the literature as
“pseudo” double-hit or non-Ig/MYC translocation; however, it has a better
prognosis than double hit/triple hit lymphomas with Ig/MYC translocations.
- Specimen requirements: Paraffin block or
- TAT: 3-5 days
- Level of service: both Global and
Tech-only options available
- NYS Approval: No
2023 AMA CPT
Good news! AMA CPT Code revisions are limited to 13 of our NGS Fusion Panels as
described below. Ewing, Rhabdomyosarcoma, NTRK, and NTRK & RET NGS Fusion
Panels are not impacted. Please note these changes are effective Monday,
Discontinuation - We want to provide a bit of
clarification around this recent test discontinuation. The test Thymidylate
Synthase (also known as TS) had two test codes in our system for the same test.
The test named ‘TS’ was discontinued effective November 21st. The test named ‘Thymidylate
Synthase’ remains active and orderable. We apologize for
any confusion this may have caused.
Ovarian Profile- Add-on FOLR1 IHC Testing
Effective as of November 18, clients ordering the NeoTYPE®
Ovarian Profile can now add-on FOLR1 IHC testing.
- FOLR1 IHC testing is indicated as an aid
in identifying patients with ovarian cancer (including epithelial ovarian
cancer, primary peritoneal cancer or primary fallopian tube cancer)
- Available as Global level of service,
please add CPT 88360
- To order, please write-in ‘add FOLR1 IHC’
on the NGS Testing Requisition or comments in Online Orders. For
Interfaced clients, please see the Interface Updates section of NeoNEWS.
- Note: FOLR1 IHC when added on to the
NeoTYPE® Ovarian Profile will be billed according to the Bill
Type on the requisition. If you would like to utilize the FOLR1 Sponsored
Testing Program for FOLR1 IHC testing instead, please visit the FOLR1
Sponsored Testing Program webpage for more information.
The CPT codes provided with our
test descriptions are based on AMA guidelines and are for informational purposes
only. Correct CPT coding is the sole responsibility of the billing party.
Please direct any questions regarding coding to the payor being billed.
The new versions of the below
requisitions for Heme services are now available. They are downloadable on Neo website.
Paper copies can be ordered with Client Services.
- Hematopathology Requisition – version 111122
- New York Hematopathology Requisition – version 111322
the complete list of interface-related test changes that took effect Monday November 21st,
for a downloadable document to view the impacted interface test codes.
Please reactivate: HSV1/2 test code 3247XHSG
Electronic ordering of the following tests is not available at this time, but
it is planned to be available in December.
-FOLR1 FDA (ELAHERE™) for Ovarian Carcinoma, Sponsored Testing Program
-(Any) NeoType Ovarian with the FOLR1 FDA (ELAHERE™) for Ovarian Carcinoma
Paper requisitions are available here.
For temporary order and result options, please contact the InterfaceTeam@Neogenomics.com
for further details.