IHC
PD-L1
22C3 FDA (KEYTRUDA®) for TNBC (Breast) is
ready for global and tech-only orders. FDA approval of this companion
diagnostic test occurred November 13, and was based on the KEYNOTE-355 study’s
findings of improved progression-free survival in certain triple-negative
breast cancer patients who were treated with chemotherapy plus Keytruda and
whose tumors expressed PD-L1 with Combined Positive Score (CPS) ≥10. Read more here.
Test Updates
HER2 FISH and IHC
As new data emerges for testing HER2 in other indications, we
want to ensure our test offerings allow for that flexibility. As a result, HER2
IHC and FISH offerings are expanding effective December 7th. Please see
our webinar “HER2 IHC & FISH Updates (Except Breast)” by Dr. Sally
Agersborg on NeoUniversity™ here.
Name and use change for HER2
Non-Breast IHC and HER2 Non-Breast FISH: The new test names
are HER2 Gastric/GEA IHC and HER2 Gastric/GEA FISH.
- Intended for gastric cancer and gastroesophageal
adenocarcinoma (GEA)
- Scoring is performed according to 2016 CAP/ASCP/ACSO
consensus guidelines for gastric/gastroesophageal adenocarcinoma
- Service levels, CPT Codes, and TAT are unchanged
New tests for colorectal
cancer: HER2 Colorectal IHC and HER2 Colorectal FISH
- Created as clinical guidelines for colon cancer
recommend following the HERACLES clinical trial scoring criteria which
differ from breast and gastric scoring. (Reference is available here)
- Global and technical service levels will be available
for both IHC and FISH. The CPT Code will be 88360x1 for IHC and 88374x1
for FISH. IHC TAT is 48hrs for Global, 24hrs for Technical. FISH TAT is
3-5 days.
New tests for other clinical
indications, including those without consensus guidelines: HER2
(Other) with either Breast Scoring or Gastric Scoring for IHC and FISH.
- Select either Breast or Gastric scoring method; Breast
Scoring will be the default
- Use of Breast Scoring is recommended for endometrial
cancer, salivary duct carcinoma, serous carcinoma, and ovarian cancer.
Scoring is performed according to 2018 CAP/ASCP/ASCO consensus guidelines
for Breast Cancer.
- Reflexes to FISH will use the same scoring that was
selected for the IHC
- Global and Technical service levels will be available
for both IHC and FISH. The CPT Code will be 88360x1 for IHC and 88374x1
for FISH. IHC TAT is 48hrs for Global, 24hrs for Technical. FISH TAT is
3-5 days.
NeoTYPE®
Cancer Profiles
These changes are effective December 7th.
NeoTYPE® Lung,
Discovery (Lung and Other), Pancreas, and Ovarian Tumor Profiles: Replace
HER2 Non-Breast FISH with HER2 (Other) FISH with Breast Scoring (no CPT change)
and add concurrent HER2 (Other) IHC with Breast Scoring (add CPT 88360x1)
NeoTYPE®
Endometrial Profile: Add concurrent HER2 (Other) IHC with
Breast Scoring and HER2 (Other) FISH with Breast Scoring (add CPT 88360x1 and
88374x1)
NeoTYPE® GI
Predictive Profile
- Replace HER2 Non-Breast FISH with HER2 Colorectal FISH
(default) or HER2 Gastric/GEA FISH (no CPT change)
- Add concurrent HER2 Colorectal IHC (default) or HER2
Gastric/GEA IHC (add CPT 88360x1)
- The above options will be available on new printed test
requisitions, but clients who want to order non-default Gastric testing
online should write in their instructions.
NeoTYPE®
Colorectal Tumor Profile: Add HER2 Colorectal IHC (add
CPT 88360x1) with reflex to HER2 Colorectal FISH (add CPT 88374x1 if reflexed)
NeoTYPE® Gastric
Profile: Add MMR IHC (add CPT 88361x4 unless opting out)
- MMR IHC testing for the detection of mismatch repair
defects is recommended for gastroesophageal and small bowel cancer
patients who are being considered for checkpoint blockade therapies.
- Image analysis is available with global and technical
levels of service.
- ‘Opt-Out’ selection will be available.
Molecular
NGS Fusion Profiles added genes
and test name changes, effective December 7th. There
are no changes to CPT Codes or turnaround times.
- Lung NGS Fusion Profile, which currently has the 6 targets ALK, NTRK1/2/3,
RET, and ROS1, will be available in two options:
- Lung Complete NGS Fusion Panel with 8 targets
including addition of MET Exon 14 skipping and the NRG1 gene. NRG1
fusions are an emerging therapy target, uncommon in NSCLC overall
(<1%) but with high prevalence of ~30% in mucinous adenocarcinoma of
the lung.
- Lung Limited NGS Fusion Panel with ALK and ROS1
omitted to leave the 6 targets MET Exon 14 skipping, NRG1, NTRK1/2/3, and
RET. This options is useful for clients who perform ALK and ROS1 FISH or
for samples that were tested previously.
- NGS Comprehensive Sarcoma Fusion Profile will be renamed Sarcoma Comprehensive NGS Fusion Panel
and it gains 70 genes (96 total) for broader reach in diagnosis and
subclassification
- NGS Non-Ewing Sarcoma Fusion Profile will be renamed Non-Ewing Sarcoma NGS Fusion Panel and
gains the SS18 gene target (24 total) for improved synovial sarcoma
detection
- NGS Ewing Sarcoma Fusion Profile will be renamed Ewing Sarcoma NGS Fusion Panel and
gains the ERG gene target (2 total) for enhanced diagnosis
NGS Fusion Profiles test name
changes only, effective December 7th. There are no changes to CPT
Codes or turnaround times.
- NTRK NGS Fusion Profile becomes NTRK NGS Fusion Panel
- NTRK & RET NGS Fusion Profile becomes NTRK & RET NGS Fusion Panel
- NGS Rhabdomyosarcoma Fusion Profile becomes Rhabdomyosarcoma NGS Fusion Panel
Discontinued Test
Molecular
NGS
Pediatric Sarcoma Fusion Profile will be discontinued
effective December 7th. Please order the Sarcoma Comprehensive NGS
Fusion Panel instead for best coverage of fusions found in pediatric sarcoma.