The biotechnology and genetic testing fields are intensely competitive both in terms of service and price, and continue to undergo significant consolidation, permitting larger clinical laboratory service providers to increase cost efficiencies and service levels, resulting in more intense competition. In addition, we may have to work with collaboration partners on one or more of our tests or development programs, which could lower the economic value of those programs to our company. We are responsible for all of the information contained in this prospectus. Under the broad sweep of the Anti-Kickback Statute, even commonplace activities such as a laboratory paying non-employee sales representatives to generate business from physician practices, could be viewed as prohibited remuneration to the sales representatives in exchange for their recommending or arranging for the purchase, by the physician practices, of laboratory services reimbursable by a federal healthcare program. In the near term, we expect to expand our IDgenetix tests from three to five therapeutic areas and, in the future, we plan to invest in continued expansion of IDgenetix and enhance our bioinformatic algorithm, with the intent to continually increase the clinical utility of our services. However, trade secrets are difficult to protect. We manage and maintain our applications and data utilizing a combination of on-site systems, managed data center systems and cloud-based data center systems.
We also store sensitive intellectual property and other proprietary business information, including that of our customers, payors and collaboration partners. We also cannot assure you that any technologies or tests that we develop will be preferred to any existing or newly developed technologies or tests. As a result, we are required to comply with both HIPAA privacy and security regulations and varying state privacy and security laws. The HITECH Omnibus Rule and subsequent regulations indicate that the laws governing transmission, privacy and security of health information are complex and evolving. Any product liability or professional liability claim brought against us, with or without merit, could increase our insurance rates or prevent us from securing insurance coverage in the future. We cannot assure you that we would be able to find another CLIA-certified facility, or that another laboratory would be willing to perform the necessary tests for us on commercially reasonable terms, or at all. Since launch and through September 30, , we completed IDgenetix tests for more than 13, patient samples, of which more than 7, samples were completed in the quarter ended September 30,
If technological innovations or other advances in medicine were serues reduce the need to conduct diagnostic v or allow our customers or other third parties to perform PGx testing services similar to ours, our business, prospects, results of operations and financial condition could be adversely affected.
One of our marketing strategies entails highlighting our ability to perform testing services and deliver an actionable report to healthcare providers in a timely manner. We use hazardous materials that require considerable expertise and expense for handling, storage or disposal and may result in claims against us.
In addition, we cannot entirely eliminate the risk of accidental injury or contamination from these materials or wastes. While this sales force focuses exclusively on physicians, they have also generated a significant number of leads for the institutional sales team due to deep client relationships within their respective geographical areas.
Federal, state and local laws and regulations govern the use, generation, manufacture, storage, handling and disposal of these materials and wastes.
Even if we were to enter into an arrangement with such provider, there can be no assurance that they will provide the same level of quality in transport services. Table of Contents financial condition. Approximate date of commencement of proposed sale to the public: The uncertainty regarding the status of LDTs under FDA regulation may negatively impact the willingness of third parties to supply us with necessary reagents and testing devices or promote our tests and may ultimately require us to seek k clearance or PMA approval for our existing products and products under development.
Neither we nor any of the underwriters has authorized anyone to althaedx you with information different from, or in addition to, that contained in this prospectus or any free writing prospectus prepared by or on behalf of us and to which we may have referred you in connection with this offering.
AltheaDx Raises $30M In Series C –
The HITECH Omnibus Rule and subsequent regulations indicate that the laws governing transmission, privacy and security of health information are alhteadx and evolving. However, trade secrets are difficult to protect. Our business, results of operations and financial condition may be adversely affected if, among other things: Any of the aforementioned sanctions could cause reputational damage, undermine our ability to maintain and increase our revenue and harm our business, financial condition and results of operations.
While we intend to notify physicians of these referral prohibitions and require them to certify that neither they nor their immediate family members have a prohibited ownership interest in our company, we cannot assure you that these efforts will be entirely successful in preventing violations of the Stark Law, or similar self-referral state laws.
A number of court cases have determined that paying commission-based compensation to independent contractor marketers can violate the Anti-Kickback Statute. This could affect our ability to continue marketing our products and to develop and introduce new products.
In addition, IDgenetix addresses the needs of physicians across multiple specialties, such as cardiologists, general practitioners, obstetricians and neurologists.
If premarket review is required by the FDA, there can be no assurance that our products will be cleared or approved on a timely basis, if at all, nor can there be any assurance that any cleared or approved labeling claims will be consistent with our current claims or adequate to support continued adoption of and reimbursement for our products.
Table of Contents compliance with applicable laws and regulations, a determination that we have violated these laws, or the public announcement that we are being investigated for possible violations of these laws, would adversely affect our business, prospects, results of operations and financial condition. If we are found to have made false or misleading claims about our products, or otherwise to have violated promotion or advertising restrictions, we may become subject to significant fines and other liabilities.
AltheaDx’s Series C Round – CB Insights
However, we expect that we may have very little control over, or altheadxx into, the conduct of any such clinical studies. The effectiveness and utility of IDgenetix has not been demonstrated in any clinical studies. These factors and other factors beyond our control could limit the commercial success of our existing tests or delay the launch of enhanced or new tests. Certain Relationships and Related Party Transactions.
The laws that may affect our ability to operate include, but are not limited to: The Office for Civil Rights of HHS, which enforces the HIPAA regulations, has been taking an increasingly rigorous approach to enforcement, and sometimes imposes penalties or settlements in excess of one million dollars.
You should read these risks before you invest in our common stock. Our tests may conflict with patents that have been or may be granted to others. Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair business efforts.
Despite our altheqdx to retain valuable employees, members of our management, scientific and development seriss may terminate their employment with us on short notice. Unlike the althdadx Anti-Kickback Statute, the Stark Law is a strict liability statute, meaning that all of the requirements of a Stark Law exception must be met in order for referrals to an entity by a physician with a financial relationship with the entity to be compliant with the law.
Table of Contents The marketing, sale and use of IDgenetix could result in substantial althewdx arising from product liability or professional liability claims that exceed our resources. We are subject to CLIA, which is administered by CMS and extends federal oversight to virtually all clinical laboratories by requiring that they be certified by the federal government or by a federally-approved accreditation agency.
San Diego, California Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to perform tests, provide test results, bill payors or patients, process claims and appeals, provide customer assistance services, conduct research and development activities, develop and commercialize tests, collect, process and prepare company financial information, provide information about our tests, educate patients and clinicians about our service and manage the administrative aspects of our business, any of which could damage our reputation and adversely altheadc our business.
Any representation to the contrary is a criminal offense. In the near term, we expect to expand our IDgenetix tests from three alrheadx five therapeutic areas and, in the future, we plan to invest in continued expansion of IDgenetix and enhance our bioinformatic algorithm, with the intent to continually increase the clinical utility of our services. Significant market alhteadx for personalized, genetic based information in treating patients.
We cannot be certain that any discussions will result in a consummated collaboration. As our sample volume increases, we expect our average cost per sample to decrease.
AltheaDx Raises $30M In Series C
Seried a PGx testing services provider, we rely extensively on our high quality of service to attract and retain healthcare providers as our customers.
Increased competition, including from competitors replicating our key service offerings in the future, and the failure to provide a higher quality of service than that of our competitors could adversely affect our revenue and profitability.
In order to successfully commercialize tests that we may develop in the future, we may need to conduct lengthy, expensive clinical studies and develop dedicated sales and marketing operations seires enter into collaborative agreements to achieve market awareness and demand. As a result, we believe our products are exempt from regulation under current FDA enforcement policies.
Although no claims against us are currently pending, we may be subject to claims that we or these consultants have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers or their former or current customers.