title: StrandAdvantage test for early-line and advanced-stage treatment decisions in solid tumors.
abstract: Comprehensive genetic profiling of tumors using next-generation sequencing (NGS) is gaining acceptance for guiding treatment decisions in cancer care. We designed a cancer profiling test combining both deep sequencing and immunohistochemistry (IHC) of relevant cancer targets to aid therapy choices in both standard-of-care (SOC) and advanced-stage treatments for solid tumors. The SOC report is provided in a short turnaround time for four tumors, namely lung, breast, colon, and melanoma, followed by an investigational report. For other tumor types, an investigational report is provided. The NGS assay reports single-nucleotide variants (SNVs), copy number variations (CNVs), and translocations in 152 cancer-related genes. The tissue-specific IHC tests include routine and less common markers associated with drugs used in SOC settings. We describe the standardization, validation, and clinical utility of the StrandAdvantage test (SA test) using more than 250 solid tumor formalin-fixed paraffin-embedded (FFPE) samples and control cell line samples. The NGS test showed high reproducibility and accuracy of >99%. The test provided relevant clinical information for SOC treatment as well as more information related to investigational options and clinical trials for >95% of advanced-stage patients. In conclusion, the SA test comprising a robust and accurate NGS assay combined with clinically relevant IHC tests can detect somatic changes of clinical significance for strategic cancer management in all the stages.
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.|Mazumdar-Shaw Center for Translational Research (MSCTR), Mazumdar-Shaw Medical Foundation, A-Block, 8th Floor #258/A, NHHealth City, Bangalore, India.
authors.forename: Manimala
authors.initials: M
authors.lastname: Sen
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Shanmukh
authors.initials: S
authors.lastname: Katragadda
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Aarthi
authors.initials: A
authors.lastname: Ravichandran
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Gouri
authors.initials: G
authors.lastname: Deshpande
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Minothi
authors.initials: M
authors.lastname: Parulekar
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Swetha
authors.initials: S
authors.lastname: Nayanala
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Vikram
authors.initials: V
authors.lastname: Vittal
authors.affiliation: Strand Life Sciences, 12635 E. Montview Blvd., Suite 360, Aurora, Colorado, 80045.
authors.forename: Weiming
authors.initials: W
authors.lastname: Shen
authors.affiliation: Strand Life Sciences, 12635 E. Montview Blvd., Suite 360, Aurora, Colorado, 80045.
authors.forename: Melanie
authors.initials: M
authors.lastname: Phooi Nee Yong
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Jemima
authors.initials: J
authors.lastname: Jacob
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.|Mazumdar-Shaw Center for Translational Research (MSCTR), Mazumdar-Shaw Medical Foundation, A-Block, 8th Floor #258/A, NHHealth City, Bangalore, India.
authors.forename: Sravanthi
authors.initials: S
authors.lastname: Parchuru
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.|Mazumdar-Shaw Center for Translational Research (MSCTR), Mazumdar-Shaw Medical Foundation, A-Block, 8th Floor #258/A, NHHealth City, Bangalore, India.
authors.forename: Kalpana
authors.initials: K
authors.lastname: Dhanuskodi
authors.affiliation: Strand Life Sciences, 12635 E. Montview Blvd., Suite 360, Aurora, Colorado, 80045.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Eyring
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Pooja
authors.initials: P
authors.lastname: Agrawal
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Smita
authors.initials: S
authors.lastname: Agarwal
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Ashwini
authors.initials: A
authors.lastname: Shanmugam
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Satish
authors.initials: S
authors.lastname: Gupta
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.|Mazumdar-Shaw Center for Translational Research (MSCTR), Mazumdar-Shaw Medical Foundation, A-Block, 8th Floor #258/A, NHHealth City, Bangalore, India.
authors.forename: Divya
authors.initials: D
authors.lastname: Vishwanath
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.|Mazumdar-Shaw Center for Translational Research (MSCTR), Mazumdar-Shaw Medical Foundation, A-Block, 8th Floor #258/A, NHHealth City, Bangalore, India.
authors.forename: Kiran
authors.initials: K
authors.lastname: Kumari
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.|Mazumdar-Shaw Center for Translational Research (MSCTR), Mazumdar-Shaw Medical Foundation, A-Block, 8th Floor #258/A, NHHealth City, Bangalore, India.
authors.forename: Arun K
authors.initials: AK
authors.lastname: Hariharan
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.|Mazumdar-Shaw Center for Translational Research (MSCTR), Mazumdar-Shaw Medical Foundation, A-Block, 8th Floor #258/A, NHHealth City, Bangalore, India.
authors.forename: Sai A
authors.initials: SA
authors.lastname: Balaji
authors.affiliation: Strand Life Sciences, 12635 E. Montview Blvd., Suite 360, Aurora, Colorado, 80045.
authors.forename: Qiaoling
authors.initials: Q
authors.lastname: Liang
authors.affiliation: Strand Life Sciences, 12635 E. Montview Blvd., Suite 360, Aurora, Colorado, 80045.
authors.forename: Belen
authors.initials: B
authors.lastname: Robolledo
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Vijayashree
authors.initials: V
authors.lastname: Gauribidanur Raghavendrachar
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Oomer Farooque
authors.affiliation: ProPath LLC, Dallas, Texas.
authors.forename: Cary J
authors.initials: CJ
authors.lastname: Buresh
authors.affiliation: Strand Life Sciences, 12635 E. Montview Blvd., Suite 360, Aurora, Colorado, 80045.
authors.forename: Preveen
authors.initials: P
authors.lastname: Ramamoorthy
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Urvashi
authors.initials: U
authors.lastname: Bahadur
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Kalyanasundaram
authors.initials: K
authors.lastname: Subramanian
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Ramesh
authors.initials: R
authors.lastname: Hariharan
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Vamsi
authors.initials: V
authors.lastname: Veeramachaneni
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.
authors.forename: Satish
authors.initials: S
authors.lastname: Sankaran
authors.affiliation: From Strand Life Sciences, 5th Floor, Kirloskar Business Park, Bangalore, India.|Mazumdar-Shaw Center for Translational Research (MSCTR), Mazumdar-Shaw Medical Foundation, A-Block, 8th Floor #258/A, NHHealth City, Bangalore, India.
authors.forename: Vaijayanti
authors.identifier: http://orcid.org/0000-0001-8716-5307
authors.initials: V
authors.lastname: Gupta
mesh_terms: D045744:Cell Line, Tumor; D056915:DNA Copy Number Variations; D004273:DNA, Neoplasm / Q000235:genetics* / Q000378:metabolism*; D056726:Genetic Association Studies; D020022:Genetic Predisposition to Disease; D059014:High-Throughput Nucleotide Sequencing / Q000379:methods*; D006801:Humans; D007150:Immunohistochemistry / Q000379:methods*; D009369:Neoplasms / Q000235:genetics / Q000378:metabolism / Q000628:therapy*; D020641:Polymorphism, Single Nucleotide; D015203:Reproducibility of Results; D017422:Sequence Analysis, DNA / Q000379:methods*; D059039:Standard of Care; D014178:Translocation, Genetic
chemical_list: D004273:DNA, Neoplasm
keywords: Clinical utility; immunohistochemistry; next-generation sequencing; solid tumors; standard-of-care therapy