Foundation Medicine reported 4,702 Clinical Tests in Q1, 715 were the FoundationOne Heme Cancer Test, average Reimbursement of $3,400 per Test
Reporter: Aviva Lev-Ari, PhD, RN
VIEW VIDEO on FoundationOne
Today, we know more about the complexity of cancer than ever before. Cancers have long been categorized and treated by where they are found in the body: lung, breast, colon, skin, blood, lymph nodes etc. However, we have known for some time that cancers are more accurately categorized by underlying alterations in DNA that drive cancer growth, which can occur in any cancer. As we understand more about these underlying alterations, traditional cytotoxic treatments are rapidly being replaced by less toxic, potentially more effective therapies that specifically target these changes in DNA that are important for cancer cell survival.
Both FoundationOne and FoundationOne Heme help physicians reveal the alterations that are driving the growth of a patient’s cancer and identify targeted treatment options that may not have been otherwise considered. FoundationOne and FoundationOne Heme are more comprehensive and identify more potential treatment options than other available tests because they analyze all genes known to be relevant in human cancers.
FoundationOne, the first clinical product from Foundation Medicine, is a fully informative genomic profile that complements traditional cancer treatment decision tools and often expands treatment options by matching each patient with targeted therapies and clinical trials that are relevant to the molecular changes in their tumor based on the most recent scientific and medical research. The test utilizes next-generation sequencing to identify alterations in all genes known to be somatically altered in human solid tumor cancers.
Test results are provided in a user-friendly interpretive report that highlights the genomic alterations that are relevant to the individual patient and provides information about targeted therapies and clinical trials to inform treatment decisions.
FoundationOne interrogates the entire coding sequence of 236 cancer-related genes plus 47 introns from 19 genes often rearranged or altered in solid tumor cancers. These genes are known to be somatically altered in solid cancers based on recent scientific and clinical literature and are sequenced at great depth to identify the relevant, actionable somatic alterations, including single base pair change, insertions, deletions, copy number alterations, and selected fusions.
VIEW VIDEO on Interactive Cancer Explorer for FoundationOne Heme Cancer Test
SOURCE
http://foundationone.com/learn.php
About FoundationOne Heme
FoundationOne Heme is a fully informative genomic profile for hematologic cancers (leukemia, lymphoma and myeloma), sarcomas and pediatric cancers, designed to provide physicians with clinically actionable information to guide treatment options for patients based on the genomic profile of their cancer. It is Foundation Medicine’s second commercially available targeted sequencing assay.
FoundationOne Heme uses comprehensive, clinical grade next-generation sequencing (NGS) to assess routine cancer specimens for all genes that are currently known to be somatically altered and unambiguous drivers of oncogenesis in hematologic malignancies, sarcomas and pediatric cancers. FoundationOne Heme simultaneously detects all classes of genomic alterations, including
- base pair substitutions,
- insertions and deletions,
- copy number alterations and
- select gene rearrangements in 405 cancer-related genes.
- In addition to DNA sequencing
FoundationOne Heme employs RNA sequencing across 265 genes to capture a broad range of gene fusions, a type of alteration that is a common driver of hematologic cancers, sarcomas and pediatric cancers
FoundationOne Technical Specs for Heme Cancer Test
http://foundationone.com/docs/FoundationOne_tech-info-and-overview(HEME).pdf
FoundationOne Technical Specs
http://foundationone.com/docs/ONE-B-001-20140430.pdf
SOURCE
http://foundationone.com/learn.php
Foundation Medicine’s Q1 Revenues More than Double
NEW YORK (GenomeWeb News) – Foundation Medicine reported after the close of the market Wednesday that its first quarter revenues rose 121 percent from the first quarter of 2013 and 19 percent sequentially, driven by sales of its FoundationOne and FoundationOne Heme cancer tests.
The Cambridge, Mass.-based cancer genomic analysis firm reported total revenues of $11.5 million for the three months ended March 31, up from $5.2 million in Q1 2013 and $9.7 million in Q4 2013. It beat the consensus Wall Street estimate of $11.3 million.
Revenue from clinical testing in the first quarter was $7.1 million, a 209 percent increase in clinical revenue from $2.3 million in the year-ago quarter and 34 percent growth from the prior quarter of $5.3 million. Revenue from its biopharmaceutical business was $4.3 million in Q1, a 47 percent year-over-year increase from $2.9 million, and on par with $4.4 million in prior quarter.
Foundation Medicine reported 4,702 clinical tests in the first quarter, up from 3,752 in the fourth quarter of 2013 and “over four times the volume” from the same quarter last year, SVP of Finance Jason Ryan noted during a conference call discussing the company’s first quarter results.
Of those tests, 715 were the FoundationOne Heme test, which the company launched last December. The company is receiving average reimbursement of $3,400 per test, Ryan said.
“The first quarter was a strong start to 2014 for Foundation Medicine, as we drove 25 percent quarter-over-quarter growth in the number of clinical tests reported to physicians, and in particular, saw early success with the adoption of our second clinical product, FoundationOne Heme,” President and CEO Michael Pellini said in a statement. “To meet the increasing demand in the clinical and pharmaceutical business areas, we are continuing to invest in our commercial and business development infrastructure and expanding our experienced sales force.”
Foundation now has a sales force of 43 and plans to increase that to between 45 and 50 sales people by the end of the year. In addition, it has three professionals dedicated to international sales and expects to at least double its international sales team by the end of the year.
Foundation Medicine posted a net loss of $12.2 million, or $.44 per share, for Q1 2014, compared to a net loss of $7.2 million, or $2.56 per share, in Q1 2013. The loss per share beat the $.48 expected by Wall Street analysts.
Its Q1 R&D expenses were $6.9 million, up from $5 million in Q1 2013. The firm’s SG&A costs were $11.4 million, up from $5 million a year ago.
Foundation Medicine also said it has expanded a collaboration with Clovis Oncologythat began in 2012 to develop an in vitro diagnostic test to identify cancer patients who may best respond to Clovis’ PARP inhibitor drug rucaparib.
The expanded agreement now includes the development of a multi-gene next-generation sequencing-based companion diagnostic test and will include development and regulatory milestone payments that will fund the building of a new lab that meets US Food and Drug Administration regulations and the costs of seeking premarket approval. “We view this expanded agreement with Clovis as an important step away from the traditional marker CDx test towards a universal companion diagnostic that can address the increasing number of targeted therapies in development for complex genomic signatures,” Pellini said.
Foundation Medicine also reiterated previous goals of reporting between 22,000 and 25,000 tests in 2014, including both its FoundationOne and FoundationOne Heme tests, and of generating revenues in the range of $52 million to $58 million.
In the first half of 2014, the company plans to launch an updated version of its FoundationOne test with an expanded set of genes for solid tumors, and in the second half of the year it plans to add new features to the Interactive Cancer Explorer physician portal.
As of March 31, the company had $110.3 million in cash and cash equivalents.
In Thursday morning trade on the Nasdaq, shares of Foundation Medicine were down 6 percent at $26.31.
Related Stories
- Foundation Medicine Revenues Climb 87 Percent in Q4 2013
February 26, 2014 / GenomeWeb Daily News
- Foundation Medicine’s Q3 Revenues More Than Double
November 7, 2013 / GenomeWeb Daily News
- Sequenom Reports 20 Percent Increase in Q1 Revenues
May 2, 2014 / GenomeWeb Daily News
- Mayo Team Shares Early Individualized Medicine Clinic Experiences, Gears Up for Expansion
April 23, 2014 / Clinical Sequencing News - Illumina Posts 27 Percent Jump in Revenues, Ups 2014 Forecast
April 23, 2014 / GenomeWeb Daily News
SOURCE
Foundation Medicine, Clovis to Co-develop IVD for Drug Candidate
NEW YORK (GenomeWeb News) – Foundation Medicine and Clovis Oncology today announced a collaboration to develop an in vitro diagnostic test to identify cancer patients who may best respond to a Clovis drug candidate currently in phase I/II clinical development.
The companies will analyze genomic changes in tissue samples from patients in order to assess the possibility of developing an IVD method directed at Clovis’ drug rucaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor. Particularly, they said, they aim to identify the additional genetic mutations beyond those in germ-line and somatic BRCA associated with defective DNA repair and that may define tumor targets for rucaparib.
The collaboration may be able to increase the percentage of ovarian cancer patients potentially eligible for rucaparib therapy from 15 percent typically found in germ-line mutations of BRCA to about 40 percent to 50 percent who have DNA repair deficiencies due to somatic mutations in a variety of genes, Foundation and Clovis said.
Financial and other terms of the deal were not disclosed.
Today’s deal marks the most recent between Foundation and a pharmaceutical firm in recent months in support of an oncology program, following agreements with Novartis,Array BioPharma, and Sanofi.
SOURCE
http://www.genomeweb.com/mdx/foundation-medicine-clovis-co-develop-ivd-drug-candidate
2012pharmaceutical
Amandeep Kaur
Aashir Awan, Phd
Abhisar Anand
Adina Hazan
Alan F. Kaul, PharmD., MS, MBA, FCCP
alexcrystal6
anamikasarkar
apreconasia
aviralvatsa
David Orchard-Webb, PhD
danutdaagmailcom
Demet Sag, Ph.D., CRA, GCP
Dror Nir
dsmolyar
Ethan Coomber
evelinacohn
Gail S Thornton
Irina Robu
jayzmit48
jdpmd
jshertok
kellyperlman
Ed Kislauskis
larryhbern
Madison Davis
marzankhan
megbaker58
ofermar2020
Dr. Pati
pkandala
ritusaxena
Rick Mandahl
sjwilliamspa
Srinivas Sriram
stuartlpbi
Dr. Sudipta Saha
tildabarliya
vaishnavee24
zraviv06
zs22
Leave a Reply