IVDT Insight

Exact Sciences Raises Funds for Cologuard Diagnostic With Stock Sale

Exact Sciences (Madison, WI) is hoping to pull in $63.7 million in a common stock sale. Funds from the stock sale will be used to pursue FDA approval of the company’s stool-based cancer diagnostic. In addition, some of the funds will be used to scale up its distribution and commercialization network.

As of now, the company will offer 5.5 million shares at $12.35 each. Underwriters have an over-allotment option that’s good for up to 825,000 more shares. Exact Sciences believes that it will be able to close the offering by this Friday, June 21.
Earlier this month, Exact Sciences submitted final PMA data to FDA regulators for its Cologuard diagnostic, a test for screening...
read more >>
June 19th, 2013
0
DxInsights and AdvaMedDx Publish Free Informational Report on Molecular Diagnostics

The independent nonprofit organization DxInsights, in collaboration with AdvaMedDx, has launched the first of a series of short, educational reports on innovative diagnostic technologies. This first report, “Essential of Diagnostics: Introduction to Molecular Diagnostics,” is now available free of charge.
"This report is the result of collaboration between AdvaMedDx and DxInsights, bringing together two organizations with a shared mission of educating a wide range of stakeholders on the value of diagnostics,” said Andrew Fish, executive director of AdvaMedDx. “This report explains clearly the basic science and technology underlying molecular diagnostics and illustrates how innovation in this field is rapidly transforming patient care. This is critical information for policy makers, patients...

read more >>
June 19th, 2013
0
Siemens Developing Companion Diagnostic for In-Development Janssen Heart-Failure Drug

Siemens Healthcare Diagnostics has entered into a collaboration with Janssen Pharmaceutica NV to design, develop, and commercialize a companion diagnostic test associated with an early-stage drug being developed by Janssen. The drug targets autoantibodies directed against the human β1-adrenergic receptor (β1-AR) that may contribute to the development of heart failure.
The agreement states that Siemens will work with Janssen to design immunoassay-based companion diagnostic tests for use in Janssen's clinical studies. The Siemens Clinical Laboratory (SCL), a "high-complexity testing laboratory designed to advance personalized medicine" according to Siemens, will develop the clinical trial assay that will be used in Janssen’s clinical trials. In parallel, Siemens will develop and validate an in vitro diagnostic test as a companion diagnostic for the Janssen therapeutic product. The companion diagnostic test will be broadly commercialized on...

read more >>
June 17th, 2013
0
BIO Issues Statement Regarding Myriad Genetics Decision

President and CEO of the Biotechnology Industry Organization (BIO) Jim Greenwood last week issued a statement on  the U.S. Supreme Court's decision regarding Myriad Genetics' patent claims on isolated DNA molecules.
On one hand, BIO expressed relief that cDNA remains eligible for patenting. "cDNA is the commercially most important form of DNA used in biotechnology," Greenwood wrote. "Today's decision offers urgently needed certainty for research-driven companies that rely on cDNA patents for investment in innovation."
On the other hand, BIO expressed disappointment that DNA molecules mimicking naturally occurring sequences are no longer patentable, calling that decision "a troubling departure from decades of judicial and Patent and Trademark...

read more >>
June 17th, 2013
0
Clinical-Test Reimbursement Bill Sports New Name, Gains More Cosponsors

A bill introduced to Congress in May of this year, H.R. 2085, now has a snappy, attention-getting name as well as some additional co-sponsors. "Diagnostic Innovation Testing and Knowledge Advancement Act of 2013," which replaces last year's dead-in-the-water H.R. 6446, "Improving Diagnostic Innovations Act of 2012," was brought by Rep. Peter Roskam (R-IL) and is currently co-sponsored by the following members of Congress:

  • Brett Guthrie (R-KY)
  • Ron Kind (D-WI)
  • Leonard Lance (R-NJ)
  • Richard Neal (D-MA)
  • Erik Paulsen (R-MN)
  • Patrick Tiberi (R-OH)
  • Larry Bucshon (R-IN; joined Jun 13, 2013)
  • Aaron Schock (R-IL)

Not surprisingly, the bill's sponsors are largely from medtech- and life-sciences-heavy states, among...

read more >>
June 17th, 2013
0
Investors Wanted for Magnet-Based Malaria Diagnostic

Magnets may hold the key for future malaria diagnostics, according to researchers at Case Western Reserve University. A new hand-held malaria detector exploits a natural property of malaria parasites. With a high iron content, the innards of a malaria parasite can be magnetized.
With high hopes for the future, researchers and students who developed the new detector are looking for investors. As part of their effort to commercialize the technology, the team incorporated itself as the Disease Diagnostic Group. Through incorporation, the team will be in better standing to solicit investments.
The new technology is very simple. Each device comprises a battery-powered box, a magnetic field, and a laser. There are several significant advantages to the new device. With an estimated price tag of $250, the device is...

read more >>
June 14th, 2013
0
Will Ruling on Human Gene Patents Hurt or Help IVD Innovation?

It's hard to argue with a unanimous Supreme Court decision, says Glen Freiberg, president of RQC Consulting and member of the IVD Technology editorial advisory board. But—and yes, there is one—the court's ruling will have an impact on the IVD industry. How significant that impact will be is up for debate.

The Association for Molecular Pathology et al. v. Myriad Genetics, Inc. ruling ends an almost two-decade monoply held by Myriad Genetics, which had patented the BRCA1 and BRCA2 genes. Mutations in either of these genes indicate a high risk of developing breast or ovarian cancer. Actress Angelina Jolie has one of those mutations and had her breasts removed, sparking a global debate in the process.

Immediately...

read more >>
June 14th, 2013
0
Exact Sciences Submits Final PMA Module for Colorectal Cancer Diagnostic

Exact Sciences (Madison, WI) submitted the final module of its Cologuard PMA to FDA regulators. Cologuard is a stool DNA colorectal cancer screening diagnostic. The final module included clinical data from the DeeP-C trial.
 
Modular PMA submissions are those in which different parts of a PMA are separated into different sections. Each module is submitted and reviewed on its own. Modular PMAs often allow for a more streamlined review process. Since FDA regulators can review information as it is received, companies can often get their product passed through the regulatory process much faster.
 
Exact Sciences’ DeeP-C trial comprised 10,000 patients in the United States. Qualified patients with ages ranging from 50 to 84 were...

read more >>
June 11th, 2013
0
Another Blood Diagnostic for Down Syndrome on the Horizon

A study published in the journal Ultrasound in Obstetrics & Gynecology could lead to another potential diagnostic for Down syndrome. (Current players in this busy field include Sequenom, Natera, Verinata, and Ariosa Diagnostics.)  Researchers at The King’s College in London created a test that can detect fetal DNA that is correlated with an increased...

read more >>
June 10th, 2013
0
Hologic and Quest Diagnostics Team Up For Women’s Health

Hologic and Quest announced that that they have entered into a strategic alliance to more broadly offer testing based on Hologic’s APTIMA family of products, as well as to co-develop and promote "advanced diagnostic solutions" to improve women’s health. The primary features of the collaboration are the national availability of the APTIMA HPV mRNA-based cervical cancer screening test, and a focus on developing and expanding access to diagnostic solutions for women’s health in general, according to the two companies.
Under a non-exclusive agreement with an initial term of five years, and in pursuit of the goals of the partnership, the companies will focus mainly on clinical areas critical to the health of women. Quest Diagnostics will transition to a...

read more >>
June 7th, 2013
0