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GeneStrat and the Competition

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Taylor Wilson

on 30 July 2015

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Transcript of GeneStrat and the Competition

GeneStrat and the Competition
The Future of Liquid Biopsy Tests
The Liquid Biopsy Space
A Liquid Biopsy is....
A diagnostic concept that analyzes therapeutic targets and resistance-conferring genetic mutations on CTCs and cfDNA that have been shed into biofluids by metastasis.

Measuring these biomarkers in the blood and other biofluids can help physicians to guide cancer treatment options
Why Liquid Biopsy?
Before Liquid Biopsy
What is a Liquid Biopsy?
Advancing Competitors
Future Progress
#1: Ability to monitor the change in tumor genetics over time to modify treatments accordingly

#2: Accessibility of the test for patients that are unable to have a biopsy or whose biopsy did not return enough tissue to properly analyze
#3: CTCs and ctDNA originate from different metastatic sites creating a broader image of the entire patient instead of a small section of a single tumor
#4: Generally cost effective with CT-guided biopsy costing upwards of $4000 and in complicated scenarios closer to $15,000
#5: Ability to avoid the risks associated with tumor biopsy procedures. For example the risk of a collapsed lung during lung biopsy
Processs uses ddPCR to analyze cfDNA
Results in 72 hours
Patients have the option to order a full panel or choose the genes individually
EGFR: Exon 19, E746-A750, Exon 21 L858R, T790M
KRAS: G12C, G12D, G12V
Plans to expand the panel to include ALK, ROS1, RET offering

Lung Select
What's Next...
Launched ImmunoSelect May 2015
ImmunoSelect service designed to identify mutant neoantigens and support development of immuno-oncology therapies
Launched LungSelect on June 11th 2015
Recently received $4.3M in funding to advance future sales
Working towards developing companion diagnostics
Tests Offered
What's Next...
Partnered with Insight in January 2015
Collaboration to generate enhanced diagnostics for expression and mutation of ALK for NSCLC treatments
Plans to add RET and MET to existing test
Tests Offered
What's Next...
Guardant360 is currently their only commercialized test
5000 tests processed as of June 2015
Over 100 hospitals and cancer centers across the US implementing Guardant360 regularly
Expanding their panel to include all genes in the NCCN guidelines
Pursuing companion diagnostic opportunities
Test Offered
Guardant360 is pan-cancer and may be used for any solid tumor cancer
These are lab developed tests such as Genestrat that have been made commercially available to physicians to aid in treatment of their patients
What's Next...
July 21st 2015, Sysmex announced a RAS test that shows high concordance (95.5% in stage IV) with tissue
LabCorp collaboration will allow central labs to perform OncoBEAM and Plasma Sequencing testing services globally locations to support oncology clinical trials
Test Offered

ClearID Breast
What's Next...
Currently, ClearID is best suited for breast cancer but other tests are in development from $25.5 million financing deal on June 15th 2015
Cynvenio accepts most insurance plans and is expanding coverage options
On June 18th 2015, Cure Forward partnered with Cynvenio on new patient activation platform that will allow oncologists to leverage data from ClearID to find best treatment options and clinical trials
Tests Offered
What research services do diagnostics companies provide and why would a pharma company benefit from these services?
Diagnostic companies like Qiagen have developed technologies to identify biomarkers in oncology
Biomarkers can be used to not only create new drugs for a disease but to predict if patients will benefit from certain types of treatment
An example of this would be Qiagen’s therascreen
October 2014
Qiagen signed a master collaboration agreement to develop and commercialize companion diagnostics by Astellas Pharma
Acquired PrimeraDx in 2014
Acquired technology and assets from AdnaGen
Acquired Enzymatics in January 2015

November 2014

Qiagen signed a master collaboration agreement with Novartis

Publicly traded company founded in 1984
Headquarters in Germany and the Netherlands
Therascreen was co-developed by Qiagen and AstraZeneca
Helps physicians to identify advanced NSCLC patients who could benefit from treatment with IRESSA when a suitable tumor sample is not available
Approved by the FDA in early July 2015
In the past they have partnered with pharma companies such as ARIAD and Novartis to develop companion diagnostics
Also involved in commercializing diagnostic tests developed by other companies

CLIA lab offering a test that analyzes ctDNA in urine using ddPCR
Test looks at mutations in BRAF V600E, KRAS and EGFR (T790M, L8F8R, Del 19)
Requires a 90-110 mL urine sample and results are >0.03% analytical sensitivity
DNA in urine tends to be much more fragmented, making testing difficult
Company also accepts blood samples for test offering
Focusing on resistance mutations found in lung, melanoma, colorectal
NRAS is next to be added to current test offering
Looking to use technology further for screening tests in oncology
"Yellow is the new red."
Rapidly growing genetic testing and diagnostics company
Currently offering pre-natal testing services
Developing diagnostic tests in oncology
Focus will be on breast, ovarian and lung cancer indications
Company uses exosome-based technology to develop diagnostic tests
Exosomes are vesicles that contain DNA and RNA
Exosomes are found in biofluids such as plasma/serum, urine, cerebrospinal fluid and saliva
Their high stability makes them an attractive source for biomarkers

Tissue Biopsy
The average cost across all patients is $14,634
Median age for lung cancer is 72
91% of lung cancer patients are 55 or older
Roughly 25% of patients are either unable to get a tissue biopsy or have an inconclusive tissue biopsy result
Unless at an academic institution, doctors are unlikely to re-biopsy and make treatment decisions without mutation information
Methods for Tissue Biopsy in Lung Cancer
Bronchoscopic biopsy
: An instrument is inserted down the airway through either the mouth or nose
Needle biopsy:
A long needle is inserted through the chest wall
Open biopsy:
In surgery, a cut is made between the ribs to access the tumor.
Video-assisted thoracoscopic surgery (VATS):
A scope is passed through a small incision in the chest
Continuing the validation of liquid biopsies through research and publications
As targeted therapies are becoming more specialized, knowing genetic mutations is of greater importance and the demand for these tests will likely increase
Pharmacogenomics shows promise as it studies the genetic response to drugs
Drug resistance monitoring will become more prevalent with liquid biopsy and better understanding of different genetic mutations
Screening for early stage cancer
Mid 2014
Early 2015
Mid 2015
Mid 2015
Early 2014
Guardant was founded by Helmy Eltoukhy and AmirAli Talasaz
Guardant patents their Digital Sequencing Technology and launches CLIA lab
Guardant launches Guardant360 test commerically
Guardant expands original test panel from 54 genes to 68 genes
At ASCO 2015 unveils tumor response map and enhanced portal
Partners with NCI on first prospective study to implement cfDNA genomic profiling for Non-Small Cell Lung Cancer
Personal Genome Diagnostics was founded by researchers at Johns Hopkins University
Personal Genome Diagnostics launches METDETECT Assay
PGDx licensed exclusive rights to Digital Karyotyping (DK), an important genome-mapping technology developed by the company’s founders at Johns Hopkins University.
Personal Genome Diagnostics launches CancerSelect and CancerComplete Test
Personal Genome Diagnostics launches ImmunoSelect Assay
Personal Genome Diagnostics launches LungSelect Test
Inostics GmbH was founded in Hamburg, Germany
Inostics GmbH was acquired by Sysmex Corp and becomes Sysmex Inostics
Sysmex Inostics and Bayer HealthCare collaborate to develop blood-based companion diagnostic tests for targeted tumor therapies
Sysmex Inostics launched OncoBEAM test commercially through CLIA lab

Currently developing tests in lung, breast and prostate cancer
In 2014 exosome dx announced partnership with Qiagen to develop liquid biopsy test for lung cancer patients
In 2013 exosome dx partnered with Eli Lilly for blood-based biomarker discovery
Lung offering expected to launch this year will include EML4-ALK and EGFR T790M
Companion diagnostic competition
Commercial Kit Competition
Next generation sequencing- massively paralleled sequencing or deep sequencing

Polymerase Chain Reaction based technologies
Sysmex announces partnership with LabCorp for development of blood based diagnostics
Diagnostics company based out of Massachusetts
Currently offering two NGS tests: FoundationOne and FoundationOne Heme
Interrogates the entire coding sequence of 315 cancer-related genes plus select introns from 28 genes often rearranged or altered in solid tumor cancers
The tissue biopsy is woefully inadequate- like trying to gauge a nations behavior by surveying a single street
- Nature
Currently offer a tissue based RT-PCR test called OncoDx
21 gene panel, test outputs a score between 0-100 to show probability of distant or local recurrence
List price is $4,175.00
Available for breast, colon, prostate
Illumina HiSeq NGS with Digital Sequencing™
Pan cancer 68 gene panel
Two 10 mL tubes of whole blood
14 days for results
Real-time PCR CEE-Selector Technology
EGFR mutations, ALK, ROS1
Two 8 mL tubes of whole blood
5-7 business days
Life Ion Torrent AmliSeq NGS Technology
50 gene panel with 30 actionable genes
Two 10 mL tubes of whole blood
8 days for results
Illumina HiSeq NGS Technology
20 mL of whole blood or 10 mL of plasma
14 days for results
BEAMing Digital PCR Technology
10 mL of whole blood or 2-5 mL of plasma
7-10 business days for results
Roche purchased 56.3% of the company for just over $1 billion dollars earlier this year
Plans to release a cell-free ctDNA assay for pharmaceutical partners by the end of this year and a commercial version of the test in early 2016
Comparing the results of the ctDNA assay to Foundation One Test in a study of over 1000 patients
Online Presence

Funding Summary

Currently offer prenatal testing services using NGS based technology
Since the launch of their MaterniT21 PLUS, 40 patients have had abnormal genetic results suggestive of cancer
To date 26 patients have been diagnosed with various cancers
Earlier this year they announced plans to develop liquid biopsy-based tests in oncology
Development is underway, early access program is planned for later this year
Interrogating over 100 genes relevant to Lung, Breast, CRC, Melanoma, Pancreas, Ovary, Bladder, Prostate, Head and Neck, Liver, Kidney, GIST, Gastric
Test Comparison
Gene Panel Comparison
Turnaround Time Comparison
Validating two thrombodx product lines:
Product Line #1: Biomarker-specific amplicon Seq kits
Product Line #2: biomarker-specific platelet PCR kits
Actively seeking partners for the co-development of platelet-powered cancer diagnostics.
Designed amplicon Seq and PCR based assays for platelet-powered diagnostics of several biomarkers, including EGFR, KRAS, and ALK.

On target to launch first liquid biopsy product in urine early 2016
Validating urine test from 500 patient multi-center study
Test will detect bladder cancer

Outward Facing Metrics
To Monitor
Cost $
Avoided Risk
AstraZeneca and Roche partner to make companion diagnostic for AZD9291
AZD9291 is a 3rd generation EGFR inhibitor and T790M resistance mutation inhibitor
Roche’s companion diagnostic determines patients who need AZD9291

Roche has branch focused in diagnostics
Large pharma that has big potential to enter the mark with more companion diagnostics
Large investment into foundation medicine recently
Full transcript