NEW YORK (GenomeWeb) – As part of an effort to "reinvigorate sample growth," Biocept has been tweaking various aspects of its business in recent months, including adding a next-generation sequencing panel to its menu of single-gene PCR assays and placing a new marketing focus on specific clinical areas where the company believes that physicians may view its liquid biopsy tests as more immediately relevant or useful.
As clinicians, guidelines bodies, regulators, and payors continue to weigh which liquid biopsy technologies and which uses of these technologies they will embrace, different companies have had varying success in growing adoption of their assays in the clinic. Biocept saw 13 percent year-over-year growth in its test volume last quarter, but the firm currently processes fewer samples than some other companies in the space.
Hoping to boost clinical adoption, the company is shifting marketing to areas where it believes it can make a better case for the utility of liquid biopsy, or where clinicians may offer a warmer reception. These include lung cancer — an area that continues to lead the liquid biopsy field as a whole — as well as breast cancer and prostate cancer, where the company believes its program to allow pathologists to perform, and bill for, certain aspects of a test in-house, is spurring new enthusiasm.
The firm saw a major milestone in lung cancer this month, launching its first multi-gene next-generation sequencing panel — run on Thermo Fisher Scientific's Ion Torrent Platform — which spurred a huge spike in the company's stock price on Monday.
Biocept's business prior to this launch was organized as a menu of individual assays, but the oncology field — with lung cancer leading the way — has seen a rapid sea change in its embrace of comprehensive NGS assays, including both regulatory and reimbursement recognition for this model emerging last year.
Apart from continuing to emphasize its offerings for lung cancer, Biocept also is focusing new marketing efforts on prostate cancer and urology, with a significant proportion of the firm's Q1 growth derived from this market, according to CEO Michael Nall. Specifically, Nall said, Biocept sees pathologists working in this space as prime targets for the firm's recently expanded Empower TC program, in which Biocept performs only the "technical component" of an assay, allowing pathologists to perform and charge for the "professional component" themselves, which includes interpreting the test results.
According to Nall, the Empower TC program now includes both circulating tumor cell enumeration and a handful of biomarker assays of interest in prostate cancer, including PTEN, and measurement of the androgen receptor splice variant AR-V7.
Banking on enthusiasm for this type of prostate cancer testing does not come without challenges, though. While many of the biomarkers in the company's overall menu are reimbursed by insurance companies when analyzed in certain tumor types, like lung cancer, others, such as AR-V7, are not currently or widely covered.
Genomic Health and Epic Science's AR-V7 test did receive a positive coverage decision from Medicare contractor Palmetto GBA last year. But the US Centers for Medicare and Medicaid Services has not issued a determination on coverage for the biomarker outside of that proprietary assay.
In breast cancer, meanwhile, Nall said that Biocept is seeing renewed interest in monitoring of circulating tumor cells, as well as growing attention to the potential utility of longitudinal testing in triple-negative cases for the emergence of targetable alterations like ER and HER2 that could make them eligible for less toxic, more effective drugs than the chemotherapy to which they would otherwise be limited.
The field has been grappling with CTC isolation and enumeration for several years. Though the CellSearch CTC platform was successfully cleared for marketing by the US Food and Drug Administration for counting CTCs to assess patient prognosis, Medicare contractors issued non-coverage determinations for the system that have not yet been reevaluated.
Nall said Biocept is trying to convince CMS to approve at least partial payment for CTC testing, essentially bringing this aspect of liquid biopsy in line with how tissue tests are billed and reimbursed. When a biomarker is tested in tissue there is separate payment for slide creation, apart from any biomarker analysis. Mirroring this, Biocept hopes to make the case that CTC isolation should be paid for, even if particular follow-on analysis is not.
Alongside pushing its marketing focus toward physicians in breast and prostate cancer, Biocept Chief Commercial Officer Edwin Hendrick said recently during the company's quarterly earnings call that the firm has also begun funneling outreach toward naturopathic doctors, or NDs.
Though their name includes the title "doctor," NDs are not graduates of the same medical schools that generate MDs. They instead train at programs accredited by their own "Council on Naturopathic Medical Education"." Naturopaths are also not required to complete medical residencies or pass the same medical board exams and licensures required of MDs.
NDs are licensed separately by several US states and Canadian provinces. In addition, the Oncology Association of Naturopathic Physicians (OncANP) awards NDs the status of "Fellow by the American Board of Naturopathic Oncology" (FABNO) if they meet requirements such as going through a two-year residency focused on naturopathic oncology that is accredited by the CNME, or having a least five years of practice with 2,250 "oncology patient contacts" and passing a case review and exam process.
According to Hendrick, there are over 5,000 naturopathic physicians practicing in the United States, many affiliated with major medical centers. There are about 80 FABNOs, he added.
Hendrick called NDs "early adopters" when it comes to monitoring patients using CTCs or ctDNA — an area that is gaining increasing attention in the research space and has begun to see the first commercial forays by companies like Natera for applications in early-stage patients.
He cited some of the applications the company is highlighting in the breast cancer arena — CTC monitoring and longitudinal testing for emerging ER, PR, and HER2 markers — as testing that naturopathic doctors have sought from the company.
Nall and Hendrick said that the company's existing interaction with NDs is both in the context of those working in integrative medicine practices instituted at major centers, including places like Memorial Sloane Kettering, Mayo Clinic, and Dana Farber, as well as "more independent" practices, though these still remain connected in some way to medical oncology practices.
Nall said that Biocept can face hurdles in making the case for its liquid biopsy tests with medical oncologists, who are increasingly busy, versus a naturopath. "We have an easier time to get in to see the integrative oncology person and more time to talk to them about what the test can do," he said.
According to Nall and Hendrick, Medicare test reimbursement does not apply to naturopathic doctors, so in cases where these practitioners are ordering tests for patients, it's a patient-pay situation, though Biocept is billing the ND as a customer, not the patient.
Because naturopaths don't receive the same medical education as MDs, Nall and Hendrick recognized that it is possible they might not have the same ability to weigh the evidence for clinical utility of these tests that traditional oncologists do. But in Biocept's experience thus far, the same tests that NDs are interested in — ER and HER2 monitoring in triple-negative breast cancer patients, for example — are also being ordered by traditional oncologists, Hendrick said.
Under the laboratory-developed test model, labs must prove their tests are analytically valid, but it is up to physicians to assess clinical utility when they consider ordering a genetic test. In this context, Nall said, it is possible for the firm to receive misguided orders from any customer, whether medical oncologists or naturopaths.
"Our medical director is very strict about what we accept and what we don't, and I can say that sometimes we get specimens that don't meet our criteria that we have to reject," Nall said. The reasons a sample may get rejected include poor sample quality, orders for a biomarker test in mismatched tissue type, or for a use the company doesn't market its tests for such as screening.
Although FDA continues to practice enforcement discretion over laboratory-developed tests, it has at times cracked down on companies that market liquid biopsy and other testing directly to consumers. The agency's view of where naturopaths fit in the doctor/consumer binary hasn't been laid out. But, according to the website of the American Association of Naturopathic Physicians, naturopathic doctors that are practicing in states where they are licensed can order diagnostic tests such as blood tests, X-rays, and MRIs.